Herpes Vaccines For 2022
Developing protective herpes simplex virus (HSV) vaccines has been an ongoing challenge for decades. Various herpes vaccine candidates are based on DNA, modified mRNA, protein subunit, killed virus and attenuated live virus vaccine technologies. The World Health Organization (WHO) recently published its preferred product characteristics for herpes simplex virus vaccines.
The herpes simplex virus exists as two biologically distinct serotypes, HSV-1 and HSV-2, which differ mainly by their transmission mode, says the U.S. CDC. And a recent Original Investigation found genital HSV-1 shedding was frequent after the first-episode genital HSV-1.
As of November 25, 2022, the U.S. FDA, Europe, Canada, India, and the U.K. had not Authorized or Approved any herpes prevention vaccine. However, there are various clinical trials actively recruiting participants.
Herpes Vaccine Candidates - 2022
The WHO, the U.S. NIH, and global partners launched STI Watch, a portal containing updated information on the most common STIs and related vaccine development status. Both preventive and therapeutic genital HSV-1 vaccines are being explored.
Current herpes vaccine candidates in clinical trials include:
mRNA-1608 is an mRNA vaccine candidate against HSV-2 disease. With mRNA-1608, Moderna Inc. aims to induce a strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity. Independent Study: An mRNA vaccine to prevent genital herpes.
Delta gD-2 (∆gD-2) is a vaccine candidate based on an HSV-2 virus genetically deleting glycoprotein D (gD-2).
HSV529 (HSV15) is a vaccine candidate classified as a replication-defective virus, meaning the virus possesses all the wild-type HSV virus components except two proteins, UL5 and UL29, involved in viral DNA replication. This phase 1/2 study was last updated on January 13, 2021, by Sanofi Pasteur and the National Institute of Allergy and Infectious Diseases.
EXD-12 is a vaccine candidate currently in preclinical testing for safety and efficacy as a prophylactic and therapeutic vaccine for both Herpes Simplex Virus-1, HSV-1, and Herpes Simplex Virus-2, HSV-2.
NanoVax is an adjuvant platform to develop a vaccine candidate to protect against the two viruses that can cause genital herpes.
GSK's Simplirix HerpeVac was in a double-blind, randomized, controlled phase 3 clinical study to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in preventing genital herpes disease in young women who are herpes simplex virus (HSV)-1 and -2 seronegative. Last updated in August 2018.
GSK's HSV vaccine clinical trial (GSK4108771A) This study has been terminated to develop an enhanced vaccine version. GSK launched the first-time-in-human phase 1 clinical study to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine when administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40 years.
RVx201 is a live-attenuated HSV-2 vaccine candidate conducting an observational clinical study RVx-001-PSS in England designed to have a specific degree of attenuation through specifically designed mutations in the ICP0 protein.
Herpes Vaccines - Preclinical Development
Redbiotec is currently developing an HSV-2 therapeutic vaccine (immunotherapy). Their vaccine program is T-cell-mediated protection and aims to outperform antivirals and allow patients to stay symptom-free for >12 months with two injections.
The VC2 vaccine candidate is a live-attenuated vaccine targeting facial, ocular, and genital herpes caused by HSV-1 and potentially protects against genital herpes caused by HSV-2.
Herpes Treatment Clinical Development
UB-621 is a first-in-class anti-gD monoclonal antibody with demonstrated viral suppression of transmission and recurrence of HSV-1 and HSV-2, developed over ten years of research collaboration between the University of Washington, and the National Institute for Allergy and Infectious Diseases, University of Duisburg Essen, Germany, and Dartmouth College.
Herpes (HSV-2) Preventive Gel Clinical Development
Researchers announced in September 2022 that they developed a gel-based lubricant that has significant potential use for thepreventions of individuals exposed to HSV-2. Cow mucus provides the basis for a synthetic prophylactic gel developed at KTH Royal Institute of Technology to protect against herpes transmission.
This Research Article was published by Advanced Science on September 14, 2022. The researchers synthesized BSM gels that liquefied under large strain and self-healed rapidly and repeatedly after the strain was removed. They showed that these properties were essential for mucin lubrication, as evidenced by significantly improved lubrication by the mucin gels (5%, wt/v) compared to mucin solutions (5%, wt/v). They also showed that the gels inhibited the infection of HSV-2 in epithelial cells and immune cells by about 80%.
Hongji Yan, a biomaterials researcher at KTH, commented in a media statement the promising results raise hope that when it becomes available as a product, the gel could help reverse troubling trends in the spread of sexually transmitted infections.
Herpes Vaccine Clinical Trials
Sponsored clinical trials are recruiting prospective participants in various studies. Herpes Cure Advocacy launched Herpes Cure Pipeline 2.0 (March 2022), which tracks preclinical and clinical study timelines and strategies globally.
Herpesviruses Association With Pre-Diabetes
On May 11, 2022, a study published in Diabetologia examined the prospective association of herpesviruses with (pre)diabetes to evaluate their potential role in diabetes etiology. Conclusions/interpretation: The associations of HSV2 and cytomegalovirus serostatus with (pre)diabetes incidence indicate that these herpesviruses may contribute to the development of impaired glucose metabolism. These study results highlight the link between viral infection and (pre)diabetes.
Genital Herpes Treatment Market
The global genital herpes treatment market is expected to grow at a CAGR of 3.76% during 2022-2028. The Acyclovir segment reported a significant share of around 50% among all drug types. The retail pharmacy segment is showing the greatest market share gain.
Herpes Vaccine Treatment Development News For 2022
October 27, 2022 - Contagion (Vol. 07, No. 5) - Revisiting Old Foes: Updates on HSV.
October 22, 2022 - The JAMA Network published an Original INvestigation - Viral Shedding 1 Year Following First-Episode Genital HSV-1 Infection - that concluded genital HSV-1 shedding declined rapidly following an initial infection and during the first year.
October 6, 2022 - Wiley Online published a Case Reported: Herpetic endotheliitis and stromal keratitis following inactivated COVID-19 vaccination. To the best of our knowledge, this is the first report of herpetic endotheliitis and stromal keratitis following the BBIBP vaccine. Although the temporal link between vaccination and adverse ocular events, including HSV-1 reactivation, cannot be established through these case reports, these reports add to the sparse body of evidence supporting this notion.
September 26, 2022 - The Fred Hutchinson Cancer Center in Washington announced researchers found substantial reductions in oral and genital viral shedding in the treated mice, with many of those treated showing no detectable virus shed. A related non-peer-reviewed study was also published: AAV-delivered gene editing for latent genital or orofacial herpes simplex virus infection reduces ganglionic viral load and minimizes subsequent viral shedding in mice.
September 23, 2022 - Nature - Scientific Reports published: HSV-1 0∆NLS vaccine elicits a robust B lymphocyte response and preserves vision without HSV-1 glycoprotein M or thymidine kinase recognition. Collectively, the results suggest (1) the live-attenuated HSV-1 mutant 0∆NLS elicits a robust B cell response that drives select B cell responses greater than the parental HSV-1 and (2) HSV-1 TK and gM are likely expendable components in the efficacy of a humoral response to ocular HSV-1 infection.
September 19, 2022 - Virios Therapeutics, Inc. announced topline results from its Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1 study of oral IMC-1 for the treatment of FM. "We believe the interplay between different COVID-19 strains and herpes virus activation may be contributing to the differential response we observed in patients enrolled in 2021 versus 2022,” stated Greg Duncan, Chairman and CEO of Virios Therapeutics.
August 19, 2022 - The journal Neurology published a RESEARCH ARTICLE: Herpes Viruses: Associations With Brain Volumes, Cognitive Performance, and Plasma Biomarkers. Discussion. These findings suggest an association of symptomatic herpes virus infection with white matter volume loss, attentional decline, and astrogliosis.
August 15, 2022 - Rational Vaccines announced the launch of an observation clinical study of RVx201 in the UK on August 3, 2022, that will recruit about 200 participants. In addition to assessing the typical baseline characteristics of the population, the purpose of this study is also to determine the acceptance of clinical trial procedures and understand the interest of the target patient population to participate in a therapeutic Phase 1/2 HSV-2 vaccine study.
July 8, 2022 - Rational Vaccines announced findings from a U.S. NIH-funded pilot study of RVX201 that showed that treatment led to a reduction in recurrent genital lesions compared to gD2-alum/MPL vaccine or placebo in vivo. In addition, RVX201 appears to generate a robust cellular immune response equivalent to that elicited by wild-type HSV-2 on Day 7 post-infection.
June 16, 2022 - Eurosurveillance reported researchers in Austria had identified a second strain of extensively drug-resistant gonorrhea. 'We describe the second global XDR N. gonorrhoeae strain, with high-level resistance to azithromycin and resistance to ceftriaxone, cefixime, cefotaxime, ciprofloxacin, and tetracycline, which caused a possible gonorrhea treatment failure with ceftriaxone (1 g) plus azithromycin (1.5 g).
June 14, 2022 - Eurocine Vaccines AB announced that it entered into a research and collaboration agreement with Redbiotec AG that transfers the exclusive global rights to develop, manufacture and commercialize vaccine candidates against Herpes Simplex Virus Type 2, HSV-2, based on the technologies developed by Redbiotec.
June 1, 2022 - Virios Therapeutics, Inc. announced the results of a pilot study performed at the University of Alabama, titled "Gastric Herpes Simplex Virus Type 1 Infection is Associated with Functional Gastrointestinal Disorders in the Presence and Absence of Comorbid Fibromyalgia: A Pilot Case-Control Study", were published in the journal Infection in April 2022. These results provide evidence for a potential mechanistic connection between active herpes virus infection and functional gastrointestinal Disorders ("FGID"), with or without comorbid fibromyalgia ("FM"), as well as the potential for combination antiviral therapy to treat patients with FGIDs and FM.
June 1, 2022 - Researchers at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB have genetically modified HSV-1 in such a way that it could be used in the fight against cancer in the future.
May 11, 2022 - Peer-review study: The health impact of seven herpesviruses on (pre)diabetes incidence and HbA1c: results from the KORA cohort. Conclusion: The associations of HSV2 and CMV serostatus with (pre)diabetes incidence indicate that these herpesviruses may contribute to the development of impaired glucose metabolism.
April 25, 2022 - Frontiers Immunology published: Combinatorial Herpes Simplex Vaccine Strategies: From Bedside to Bench and Back. 'We discussed that a prime/pull vaccine strategy that use of asymptomatic epitopes, combined with immune checkpoint blockade would prove to be a successful herpes vaccine approach.'
April 11, 2022 - In this issue of Pediatrics, Liddon et al. provide national data on STI testing among sexually active youth. The AAP published 'Annual STI Testing Among Sexually Active Adolescents.' A significantly higher proportion of female (26.1%) than male (13.7%) students reported testing for STI.
April 1, 2022 - Aurobindo Pharma Limited received final approval from U.S. FDA for its Abbreviated New Drug Application Acyclovir Oral Suspension USP, 200 mg/5 mL. Aurobindo Pharma's Acyclovir Oral Suspension; is an AB-rated generic equivalent to the reference listed drug, ZOVIRAX®. Acyclovir Oral Suspension is indicated to treat initial episodes and manage recurrent episodes of genital herpes.
February 18, 2022 - Moderna, Inc. issued a statement: "We are pleased to announce these new development programs, which reflect the continued productivity of our platform and the potential of our mRNA technology to impact the lives of hundreds of millions of people," said Stéphane Bancel, CEO of Moderna. "We are committed to addressing latent viruses with the goal of preventing the lifelong medical conditions that they cause with our mRNA vaccine programs. With our HSV candidate, we also hope to improve the quality of life for those with symptomatic disease."
January 25, 2022 - PNAS published a study that developed a parameterized model predicting how much and how rapidly a betaherpesvirus-vectored transmissible vaccine can be expected to reduce the prevalence of a target pathogen. The study concluded 'Our models are focused on transmissible vaccines designed using herpes virus vectors and demonstrate that these vaccines—currently under development for several important human pathogens—may have the potential to rapidly control zoonotic pathogens within the reservoir hosts. However, our study results suggest that the effectiveness of MCMV-vectored transmissible vaccines may depend on the virus strain used to construct the vaccine and the target population into which the vaccine is ultimately deployed.'
December 20, 2021 - The Lancet published a study: Global burden and trends of sexually transmitted infections from 1990 to 2019: an observational trend study. Interpretation: Although most countries showed a decrease in age-standardized rates of incidence and DALYs for STIs, the absolute incident cases and DALYs increased from 1990 to 2019. Therefore, STIs still represent a global public health challenge, especially in sub-Saharan Africa and Latin America.
December 14, 2021 - Rational Vaccines announced the launch of a clinical trial designed to investigate the disease burden of herpes simplex virus types 1 and 2 in patients with HIV infection. The study, "A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects," will be led by Jorge E. Rodriguez, M.D., and conducted at the Global Research Institute in Los Angeles, CA. Please contact Debra Barile at [email protected].
December 7, 2021 - Researchers from the Department of Ophthalmology, Saint Louis University School of Medicine, published a new study in frontiers in Microbiology: Developments in Vaccination for Herpes Simplex Virus. 'Within this article, we review the current guidelines for the treatment of herpes simplex infections, our understanding of the immunological pathways involved, and novel vaccine candidates in development.'
November 17, 2021 - Northwestern University Feinberg School of Medicine researchers uncovered new ways to treat or even prevent HSV infections. Published in the journal Nature, this study's explained using herpes simplex virus type I and pseudorabies virus as model alphaherpesviruses, they showed that a cellular kinesin motor is captured by virions in epithelial cells, carried between cells, and subsequently used in neurons to traffic to nuclei. Viruses assembled in the absence of kinesin are not neuroinvasive. This is a critical component of the alphaherpesvirus neuroinvasive mechanism and demonstrates that these viruses assimilate a cellular protein as an essential proviral structural component. This principle of viral assimilation may prove relevant to new strategies to combat infection.
November 15, 2021 - Frontiers in Immunology published ORIGINAL RESEARCH that indicates an 'ocular challenge of mice immunized with the VC2 vaccine (RVx201) induce a unique ocular mucosal response that leads into the infiltration of γδ T cells resulting in the amelioration of infection-associated immunopathogenesis.' Background: Herpetic Keratitis induced by HSV-1 ocular infection is a leading cause of infectious blindness. It is estimated that 50-90% of the world population is infected with HSV-1. Primary infection of HSV-1 targets mucosal regions such as the oral lining and skin.
October 18, 2021 - United BioPharma announced that Shanghai Public Health Clinical Centre and Cheng Kung University's Department of Microbiology and Immunology will test the effectiveness of UB-621, a long-acting treatment for genital herpes caused by HSV 1 and HSV2 in preparation for phase II trials in the U.S. and China. UB-621 is a first-in-class anti-gD mAb with demonstrated strong viral suppression of transmission and recurrence of HSV1 and HSV2.
September 13, 2021 - Nature Communications published a new study: OPTN is a host intrinsic restriction factor against neuroinvasive HSV-1 infection. Fast-replicating neurotropic herpesviruses exemplified by herpes simplex virus-1 (HSV-1) naturally infect the central nervous system (CNS). Optineurin (OPTN) is a conserved autophagy receptor with little understanding of its role in neurotropic viral infections. We show that OPTN selectively targets HSV-1 tegument protein, VP16, and the fusion glycoprotein, gB, to degradation by autophagy. Furthermore, OPTN-deficient mice challenged with HSV-1 show significant cognitive decline and susceptibility to lethal CNS infection. Furthermore, OPTN deficiency unveils severe consequences for recruitment of adaptive immunity and suppression of neuronal necroptosis. Ocular HSV-1 infection is lethal without OPTN and is rescued using a necroptosis inhibitor. These results place OPTN at the crux of neuronal survival from potentially lethal CNS viral infections.
July 22, 2021 - Rational Vaccines announced that it had been awarded an Innovation Passport under a new process in the United Kingdom to bring innovative medicines more rapidly to patients. The Company has received the Innovation Passport for RVx201, a live-attenuated therapeutic vaccine candidate developed for genital herpes resulting from the herpes simplex type 2 (HSV-2) virus. RVx201 is a first-in-human HSV-2 live-attenuated therapeutic vaccine modified to be interferon sensitive and destroy the ability of the virus to inhibit immune responses.
May 19, 2021 - Biospace reported X-Vax Technology is preparing to submit an Investigational New Drug Application to the U.S. FDA for its experimental vaccine Delta gD-2 targeted against herpes simplex virus 1 and 2.
April 22, 2021 - UPenn Medicine's Friedman, Weissman, and colleagues are developing an mRNA HSV-2 vaccine. Before the COVID-19 pandemic, a study of their mRNA vaccine in mice showed that almost all mice that were vaccinated and then exposed to HSV-2 had sterilizing immunity, which meant there was no amount of the disease present in the body after the exposure.
April 16, 2021 - At a virtual conference, Morgane Linard, University of Bordeaux, France, linked brain-tissue changes and a higher AAlzheimer'sdisease (AD) incidence to HSV infection ApoE4 carriers doing worse. At the meeting, Oliver Goldhardt, Technical University of Munich, tied AD biomarkers in the cerebrospinal fluid to herpes infection. Both teams measured herpes infection by detecting anti-HSV immunoglobulin G in participants' blood or CSF.
April 13, 2021 - A new study was published by Rheumatology - Herpes zoster following BNT162b2 mRNA COVID-19 vaccination in patients with autoimmune inflammatory rheumatic diseases: a case series. Epidemiologic studies on the safety of the mRNA-based COVID-19 vaccines in patients with AIIRD are needed to clarify the association between the BNT162b2 mRNA vaccination and the reactivation of zoster.
April 10, 2021 - The NEJM published the results of a limited, phase 1 brain tumor study investigating intratumoral G207 alone and with radiation. Sponsored by the University of Alabama at Birmingham, G207 is an oncolytic herpes simplex virus-1 (HSV) treatment successfully engineered to introduce mutations in the virus that enable it to replicate in and kill cancer selectively but not normal cells.
April 5, 2021 - Rational Vaccines announced a license agreement for the work of Louisiana State University virologist Dr. Konstantin "Gus'Kousoulas from LLSU'sSchool of Veterinary Medicine in the Division of Biotechnology & Molecular Medicine that furthers RRational'score mission of eliminating herpes virus. In several animal model studies, the vaccine technology, known as VC2, demonstrated great promise in treating Herpes Simplex Virus 1 and 2 and facial and ocular herpes. Unlike vaccines that use individual viral proteins to vaccinate patients, VC2 is a live-attenuated, engineered version of HSV-1. Because VC2 prevents HSV from entering the body's neurons, Kousoulas believes it is a safe and effective option for preventing and potential treatment of herpes.
April 5, 2021 - Texas-based Maxwell Biosciences announced that the peer-reviewed, open-access journal Pharmaceuticals published scientific research findings co-authored by Gill Diamond, Ph.D. (University of Louisville), and eleven other collaborating academic researchers. Titled Potent Antiviral Activity against HSV-1 and SARS-CoV-2 by Antimicrobial Peptoids, the research findings demonstrate that several peptoids exhibit potent in vitro antiviral activity against both Herpes Simplex Virus-1 (HSV-1) and SARS-CoV-2. As outlined in the paper's abstract, viral infections, such as those caused by HSV-1 and SARS-CoV-2, affect millions of people each year.
March 30, 2021 - According to a study published in the journal Vaccines, two novel vaccine candidates for the prevention and treatment of genital herpes are safe in preclinical animal studies. These results are encouraging and validate the need for continued development and testing of these live-attenuated vaccine candidates, which are historically underdeveloped vaccine types for the treatment or prevention of genital herpes," "aid Jonathan Joyce, the lead author of the study and Ph.D. candidate in Dr. Andrea BeBertke'sroup at the Department of Population Health Sciences, Virginia Tech.
March 19, 2021 - A study of Rational VaVaccines'erpes simplex virus candidate published in the Journal of Virology demonstrates that the vaccine candidate, RVX10, offered robust protection against ocular herpes simplex virus 1 (HSV-1) infection in vaccinated mice. The significant finding of the study, "Herpes Simplex Virus 1 (HSV-1) 0ΔNLS Live-Attenuated Vaccine Protects against Ocular HSV-1 Infection in the Absence of Neutralizing Antibody in HSV-1 gB T Cell Receptor-Specific Transgenic Mice, found that the cocompany'sVX101 vaccine candidate used to immunize a unique mouse line (does not generate much of a neutralizing antibody response to the virus) was shown to provide highly protective immunity and prevent herpes-associated neovascularization. Furthermore, this robust efficacy was correlated with CD8+ T cells since depleting these cells after vaccination, but before the challenge with HSV-1 eliminated any efficacy realized by the vaccine.
March 18, 2021 - GlaxoSmithKline launched a Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of gE/gI SAM (LNP) Vaccine in (60) Healthy Participants Aged 18-40 Years.
March 13, 2021 - The journal Vaccines published a study: Assessment of Two Novel Live-Attenuated Vaccine Candidates for Herpes Simplex Virus 2 (HSV-2) in Guinea Pigs. Two experimental, novel live-attenuated HSV-2 vaccine candidates (RVx201 and RVx202) have been tested preclinically for safety. This study's findings suggest that these novel vaccine candidates are safe in guinea pigs and should be tested for efficacy as preventative and/or therapeutic anti-HSV-2 vaccines.
March 5, 2021 - The BMJ published an opinion article, 'Understanding the spectrum of vaccine efficacy measures efficacy against severe disease is perhaps of greatest clinical relevance. Yet vaccine efficacy for preventing infection is harder to measure reliably. Preventing infection clearly also prevents transmission and symptoms, yet vaccines can offer clinical benefits by priming the immune system to prevent symptoms even despite infection. Thus, vaccine efficacy against infection cannot be higher than efficacy against disease. For example, from another disease, in 2012, the efficacy of a herpes simplex vaccine against herpes simplex virus one genital disease was 58% (95% CI 12 to 80%). Still, efficacy against herpes simplex virus 1 infection was 35% (95% CI 13 to 52%).
February 26, 2021 - Massachusetts-based Rational Vaccines announced virologist joined the Company as vice president of Scientific Affairs. He will further its core mission of eradicating the world of the herpes simplex virus.
February 14, 2021 - RESEARCH ARTICLE: Herpesvirus infections, antiviral treatment, and the risk of dementia—a registry‐based cohort study in Sweden. Antiviral therapy was associated with a reduced long‐term risk of dementia among individuals with overt signs of herpes infection. This is consistent with earlier findings indicating that herpes viruses are involved in the pathogenesis of AD.
February 12, 2021 - Study: Neuronal hyperexcitability is a DLK-dependent trigger of herpes simplex virus reactivation that IL-1 can induce. 'HIV-1 co-opts an innate immune pathway resulting from IL-1 stimulation of neurons to induce reactivation.'
'February 12, 2021 - The journal Nature published a study: Transient editing catches the eye. A one-shot transient approach for therapeutic gene editing is, therefore, an advantageous proposition on many fronts.
February 10, 2021 - Commercial firms in the herpes marker testing market make strides for diagnostic tests for HSV1- and HSV- 2. In 2014, Simplexa HSV 1 and HSV 2 direct molecular tests by Quest Diagnostics were the first to receive U.S. FDFDA'spproval. The Simplexa test is the first approved by the U.S. FDA, enabling qualitative differentiation and detecting HSV-1 and HSV- 2 in cerebrospinal fluid.
February 9, 2021 - Quercus Molecular Design (QMD) develops broad-spectrum antiviral drugs with indications ranging from herpes viruses to SARS-CoV2. Sandra Weller, QMQMD'shief biology officer and Board of Trustees Distinguished Professor of molecular biology and biophysics in UCUConn'school of Medicine, studied the mechanism of replicating human herpes viruses for more than 40 years. Weller paired her in-depth understanding of the molecular mechanisms of viral replication with Dennis WrWright'sxpertise, a professor of medicinal chemistry in the UConn School of Pharmacy and QMQMD'shief chemistry officer.
February 9, 2021 - According to Google Trends, searches for the term "shingles" peaked in popularity on the search engine over the past week. "T" ere is no scientific evidence of this [association]," "ays Aaron Glatt, MD, chief of infectious diseases at Mount Sinai South Nassau in Oceanside, NY, and a spokesperson for the Infectious Diseases Society of America, reported WebMD.
February 3, 2021 - RESEARCH ARTICLE published by PLOS: A Phase I randomized trial is a monoclonal antibody-based vaginal multipurpose prevention film (MB66). Single and repeated intravaginal applications of MB66 film were safe, well-tolerated, and acceptable. Concentrations and ex vivo bioactivity of both mAbs in vaginal secretions were significantly elevated and could protect for at least 24 hours postdose. However, further research is needed to evaluate the efficacy of MB66 film in women at risk for HIV and HSV infection. Additional antibodies could be added to this platform to protect against other sexually transmitted infections and contraception.
February 1, 2021 - Virios Therapeutics, Inc. (Nasdaq: VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that it is entering a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS). The overactive immune response related to activation of tissue-resident Herpes Simplex Virus-1 ("H" V-1") "has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel disease, chronic fatigue syndrome, and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of the disease.
January 13, 2021 - Study Update of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection. Phase I Study of the Safety of replication-defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection. Study Start Date: September 26, 2013.
January 11, 2021 - A press release by Rational Vaccines herpes focused on the study published in the Journal of Virology on November 23, 2020, demonstrates that the vaccine candidate, RVX10, offered robust protection against ocular herpes simplex virus 1 (HSV-1) infection in vaccinated mice found that the Company's VX101 vaccine candidate used to immunize a unique mouse line (does not generate much of a neutralizing antibody response to the virus) was shown to provide highly protective immunity and prevent herpes-associated neovascularization. This robust efficacy was correlated with CD8+ T cells since depleting these cells after vaccination but before challenge with HSV-1 eliminated any usefulness realized by the vaccine.
November 30, 2020 - In this systematic review of Medline, EMBASE, and PubMed studies, there were 16 articles deemed relevant comprising both animal and human studies (301 patients) regarding the use of the Bacillus Calmette‐Guérin (BCG) vavaccine'sff-target effects that might impact the recurrence of HSV infections. In non-randomized human studies (that failed to control for a placebo effect), BCG vaccination appeared beneficial in 78 percent of adults with recurrent herpes genitalis or labialis, with 37 percent being recurrence‐free for an extended period, 41 percent experiencing less frequent or severe episodes, and only 22 percent reported no change. This clinical benefit is consistent with the findings of immunological sub‐studies. In addition, in the two studies restricted to recurrent herpes labialis, 94 percent appeared to benefit from BCG.
November 23, 2020 - Study published by American Society for Microbiology: Collectively, the study suggests CD8+ T cells significantly contribute to the host adaptive immune response to HSV-1 challenge following vaccination with an attenuated virus, but multiple factors are involved in cornea pathology in response to ocular virus challenge. The current study shows that in the near absence of anti-HSV-1 antibodies, vaccinated mice are protected from subsequent challenges with wild-type HSV-1 as measured by survival. The efficacy is lost following the depletion of CD8+ T cells. Whereas increased survival and reduction in virus replication were observed in vaccinated mice challenged with HSV-1, cornea pathology was mixed with a reduction in neovascularization but no opacity change.
November 6, 2020 - Study published by Nature: The R2 non-neuroinvasive HSV-1 vaccine affords protection from genital HSV-2 infections in a guinea pig model. The use of live-attenuated HSV vaccines that robustly replicate mucosal tissues but are ablated for neuroinvasion offers a promising approach for HSV vaccines. The study found that vaccinating guinea pigs with the modified live virus significantly increased virus-combating antibodies. In addition, when challenged with a virulent strain of the herpes simplex virus, the vaccinated animals displayed fewer genital lesions, less viral replication, and less viral shedding that most readily spreads the infection to others.
November 3, 2020 - Protection against herpes simplex virus type 2 infection in a neonatal murine model using a trivalent nucleoside-modified mRNA in lipid nanoparticle vaccine. Neonatal herpes is a dreaded complication of genital herpes infection in pregnancy. We recently compared two vaccine platforms for preventing genital herpes in female mice and guinea pigs. We determined that HSV-2 glycoproteins C, D, and E expressed using nucleoside-modified mRNA in lipid nanoparticles provided better protection than the same antigens produced as baculovirus proteins and administered with CpG and alum.
September 25, 2020 - Study: Cell entry of enveloped viruses requires specialized viral proteins that mediate fusion with the host membrane by substantial structural rearrangements from a metastable pre- to a stable postfusion conformation. This metastability renders the herpes simplex virus 1 (HSV-1) fusion glycoprotein B (gB) highly unstable such that it readily converts into the postfusion form, thereby precluding structural elucidation of the pharmacologically relevant prefusion conformation.
September 24, 2020 - Study review: the BCG vaccine is a potential, safe, affordable, and readily available candidate intervention to decrease the high burden of disease associated with HSV infection and recurrences, but properly controlled randomized trials are required.
September 24, 2020 - Study: In summary, almost half of patients with mild‐to‐moderate COVID‐19 admitted in a field hospital during a 2‐week period showed mucocutaneous findings. The oral cavity was frequently involved and deserves specific examination under appropriate circumstances to avoid contagion risk. Redness and swelling of the hands and feet, fine palmoplantar desquamation, and reddish‐to‐brown macules can help us diagnose COVID‐19 infection and be routinely checked.
August 18, 2020 - A recent study evaluated HSV gene editing in a well-established mouse model, using adeno-associated virus (AAV)-delivered meganucleases as a potentially curative approach to treat latent HSV infection. Here we show that AAV-delivered meganucleases, but not CRISPR/Cas9, mediate highly efficient HSV gene editing, eliminating over 90% of latent virus from superior cervical ganglia. The levels of HSV elimination observed in these studies, if translated to humans, would likely significantly reduce HSV reactivation, shedding, and lesions.
August 14, 2020 - Research study: HVEM signaling promotes protective antibody-dependent cellular cytotoxicity vaccine responses to herpes simplex viruses.
July 27, 2020 - RESEARCH ARTICLE: An HSV-2 nucleoside-modified mRNA genital herpes vaccine containing glycoproteins gC, gD, and gE protects mice against HSV-1 genital lesions and latent infection.
July 27, 2020 - Vaccines against Genital Herpes: Where Are We? Because of the high burden of genital herpes, HSV vaccines have been developed, but none have been very successful. This review discusses the current status of genital herpes vaccine development.
July 27, 2020 - In a mice study, these researchers compared protection by the HSV-2 mRNA vaccine against genital HSV-1 and HSV-2 infection. Mice infected with either virus were totally protected from genital disease. Significantly, in two experiments, the mRNA vaccine prevented HSV invasion of the dorsal root ganglia, the site of virus latency, in 39/40 (97.5%) mice infected with either HSV-1 or HSV-2. Thus, they conclude that the HSV-2 trivalent mRNA vaccine provides potent protection against HSV-1 and HSV-2 genital infection and is a promising vaccine candidate for human trials.
July 24, 2020 - A new study stated that over 65% of young people have their first sexual activity unexposed to herpes but risk catching it in adulthood. In addition, this research found fewer people are being exposed to HSV-1, also known as oral herpes, in their youth.
July 23, 2020 - Study: Tetrameric glycoprotein complex gH/gL/gQ1/gQ2 is a promising vaccine candidate for human herpesvirus 6B. HHV 6 is a group of various viruses belonging to the herpes virus family. HHV-6B causes a disease called exanthema subitum or roseola infantum in children and infants. It is one of the most common causes of emergency hospitalization in children up to 3 years of age. HHV6B tetramer or gH/GL/gQ1/gQ2 is a protein on the surface of the HHV6 virus that interacts with the human CD134 (a protein present on T cells) to gain entry into host cells. As viruses are intracellular parasites, they need a living cell to survive.
July 21, 2020 - The story of Rational VaVaccines'ursuit of a therapeutic vaccine for genital herpes may go down as one of the strangest and most controversial chapters in the history of drug or vaccine development.
July 17, 2020 - This article sheds light on the molecular and structural interactions between HHV-6B tetramer and its host receptor, along with their neutralizing antibodies and their affinities, competition, and binding modes based on the HHV-6B tetramer structure are described. Our findings provide molecular and structural bases for a comprehensive understanding of these interactions and relationships.
July 16, 2020 - Herpes simplex virus type 1 in Europe: a systematic review, meta-analyses, and meta-regressions. The results showed that more than two-thirds (67.4%) of tEtEurope'spopulationested positive for HSV-1, which is far lower than the historical level of universal infection in childhood in other parts of the world such as Africa. Around 32.5% of children and 74.4% of adults were infected in Europe. The results also showed that half of the first-episode genital herpes cases in Europe were already due to HSV-1 instead of HSV-2 infection.
July 9, 2020 - Meta-analytic approach for transcriptome profiling of herpes simplex virus type 1.
June 13, 2020 - Study: 'I' this review, I have briefly described some of the models available and then more thoroughly describe the guinea pig model of acute and recurrent genital herpes infections. As discussed, the guinea pig model most closely mimics human disease and provides several essential endpoints for evaluating vaccines and antivirals.'
'arch 3, 2020 - Tissue-resident T cell-derived cytokines eliminate herpes simplex virus-2–infected cells.
May 22, 2020 - Study: In pigs, assess the properties and efficacy of an R2 vaccine derived from the alpha-herpesvirus, pseudorabies virus (PRV). We demonstrate that the PRV R2 vaccine does not invade the porcine peripheral nervous system within detection limits. Furthermore, after a single intranasal vaccination, R2 conferred protection to pigs subsequently challenged with a virulent PRV field strain (NIA-3). These findings support that the R2 vaccine design is non-neuroinvasive and is an effective vaccine in the context of a natural host.
May 19, 2020 - Genocea Biosciences, Inc. announced it has entered into a material transfer agreement and exclusive license option with Shionogi & Co., Ltd. to develop a novel HSV-2 vaccine using GeGenocea'sroprietary HSV-2 antigens from the GEN-003 program.
May 7, 2020 - This model recapitulates clinical responses to natural infection and the rgD-2 vaccine trial outcomes and suggests that ΔgD-2 may prove protective in HSV-1-seropositive hosts.
May 6, 2020 - Newly published research is the first to show in a lab model that the herpes simplex virus HSV-1 might cause AlAlzheimer'sIn the study; scientists found that mini 3D models of the human brain, when infected with the virus that causes cold sores, developed hallmarks of AlAlzheimer'sincluding amyloid plaque-like formations and neuroinflammation.
May 1, 2020 - The WHO issued a statement saying, 'About half a billion people worldwide live with genital herpes. New estimates show that several billion have an oral herpes infection, highlighting the need to improve awareness and scale-up services to prevent and treat herpes.'
'arch 17, 2020 - Study: Lessons learned from prior vaccine studies and select candidate vaccines are discussed, including a trivalent nucleoside-modified mRNA vaccine that our laboratory is pursuing.
March 2, 2020 - WSU researchers recently published a study in the American Society for MiMicrobiology'sournal mSphere that is the first to identify how one of the virus proteins acts as a critical signaler for the virus to succeed in infecting a cell.
April 27, 2020 - Study: Based on our revised annotation of 201 viral transcripts and 284 ORFs, we extended the existing nomenclature to include all our novel viral gene products. This did not involve any renaming of previously described viral gene products. Our terminology thereby explains the gene expression of most viral ORFs in the context of different transcript isoforms, uORF, and uoORFs. This will facilitate functional studies on the viral gene products and their transcriptional and translational regulation.
February 11, 2020 - Study: Current Antivirals and Novel Botanical Molecules Interfering With Herpes Simplex Virus Infection.
February 6, 2020 - Study: Intramuscular vaccination of mice with the human herpes simplex virus type-1(HSV-1) VC2 vaccine, but not its parental strain HSV-1 (F), confers complete protection against lethal ocular HSV-1 (McKrae) pathogenesis.
January 10, 2020 - Sanofi announced Phase 1 and 2 studies were posted. The study's primary objectives are: To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). In addition, to evaluate the efficacy of the investigational vaccine regimens concerning the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule; the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule.
January 8, 2020 - Candel Therapeutics announced that the acquisition consolidates a next-generation herpes drug development platform and manufacturing expertise tailored to multiple tumor types and indications.
December 17, 2019 - Immune responses to an HSV-2 polynucleotide immunotherapy COR-1 in HSV-2 positive subjects: A randomized double-blinded phase I/IIa trial. This study confirms the previously demonstrated safety of COR-1 in humans and indicates a potential for using COR-1 as a therapy to reduce viral shedding in HSV-2 infected subjects.
December 10, 2019 - A recent study provides new insights into the early stages of a Herpes Simplex Virus 1 (HSV-1) infection. It serves as a general blueprint for investigating heterogeneous cell states in virus infection.
December 5, 2019 - A recent study said 'a'aignificant burden of Human Immunodeficiency Virus (HIV) is likely attributable to a Herpes Simplex Virus type 2 (HSV-2) infection.
November 21, 2019 - Cornell University researchers hoping to learn what switches this life-long virus between latent and lytic stages may have found the 'hidden 'answer to this question.
November 18, 2019 - Global and regional estimates of the contribution of herpes simplex virus type 2 infection to HIV incidence: a population attributable fraction analysis using published epidemiological data. A significant burden of HIV is likely to be attributable to HSV-2 infection, even if the effect of HSV-2 infection on HIV had been imperfectly measured in studies providing adjusted RR estimates, potentially because of residual confounding. The contribution is likely to be most significant in areas where HSV-2 is highly prevalent, particularly in Africa. New preventive interventions against HSV-2 infection could not only improve the quality of life of millions of people by reducing the prevalence of herpetic genital ulcer disease but could also have an additional, indirect effect on HIV transmission.
September 20, 2019 - A new herpes simplex 2 virus vaccine study in animals reported an experimental vaccine developed at the University of Pennsylvania had prevented genital lesions in 98% of mice and guinea pigs tested. This trivalent vaccine protected mice and guinea pigs from developing genital lesions and reduced viral shedding. Neutralizing antibody and CD4+ T cell responses were detected in immunized mice. Penn has licensed certain Penn-owned intellectual property to BioNTech for the development and commercialization of mRNA vaccines for infectious diseases, including IP rights related to an HSV-2 mRNA vaccine.
July 23, 2019 – A patent was issued on February 19, 2019, which protects the use of BlueWillow BiBiologics'nique NanoVax adjuvant platform to develop a vaccine that protects against HSV-1 and HSV-2.
July 23, 2019 - X-Vax Technology, Inc. announced that it had raised $56 million in an upsized Series A financing with participation from strategic and institutional investors, including Johnson & Johnson Innovation – JJDC, Inc. Proceeds from the financing will be used to advance the program, a vaccine candidate against herpes, called ∆gD-2 (delta gD-2), for further development and production, including a Phase 1 clinical study.
June 15, 2019 – A new study published in Nature on June 12, 2019, by Yale researchers offered insights that could lead to a better genital herpes therapeutic vaccine.
May 2, 2019 - Numerous epidemiological, clinical, and immunological studies demonstrate that BCG vaccination impacts subsequent infections immune response resulting in reduced morbidity and mortality. Important lines of evidence indicating that BCG protects against viral pathogens come from experimental studies in mice showing that BCG offers protection against various DNA and RNA viruses, including herpes and influenza viruses. Recently, BCBCG'sffect on an experimental viral infection in humans has been demonstrated. These effects are thought to be mediated via the induction of innate immune memory and heterologous lymphocyte activation, resulting in enhanced cytokine production, macrophage activity, T-cell responses, and antibody titers.
April 17, 2019 - Therapeutic Mucosal Vaccination of Herpes Simplex Virus 2-Infected Guinea Pigs with Ribonucleotide Reductase 2 (RR2) Protein Boosts Antiviral Neutralizing Antibodies and Local Tissue-Resident CD4+ and CD8+ TRM Cells Associated with Protection against Recurrent Genital Herpes.
March 27, 2019 - Research article: Duration of protection from live attenuated vs. sub unit HSV-2 vaccines in the guinea pig model of genital herpes: Reassessing efficacy using endpoints from clinical trials.
January 22, 2019 - Study: Vaccine-induced antibodies target sequestered viral antigens to prevent ocular HSV-1 pathogenesis, preserve vision, and preempt productive neuronal infection.
November 22, 2018 - Study: The live attenuated prophylactic HSV vaccine, VC2, was effective in the guinea pig model of genital HSV-2. Its decreased ability to infect neural tissues provides advantages over other live attenuated vaccines. The live attenuated prophylactic HSV vaccine, VC2, was effective in the guinea pig model of genital HSV-2. Its decreased ability to infect neural tissues provides advantages over other live attenuated vaccines.
August 11, 2018 - Herpes simplex virus‐2 dynamics probe measures the extremely rapid and spatially localized tissue‐resident T‐cell response.
October 28, 2015 - Global and Regional Estimates of Prevalent and Incident Herpes Simplex Virus Type 1 Infections in 2012.
October 6, 2015 - Original Research: Cost-Effectiveness of Herpes Zoster Vaccine for Persons Aged 50 Years.
January 9, 2014 - Review: The challenge of developing herpes simplex virus 2 vaccines.
January 5, 2012 - The NEJM published an original article: Efficacy Results of a Trial of a Herpes Simplex Vaccine. In a study population representing HSV-1– and HSV-2–seronegative women's general population, the investigational vaccine effectively prevented HSV-1 genital disease and infection but not in preventing HSV-2 disease or infection.
Russian Herpes Vaccine
Vitagerpavac is the only multivalent vaccine globally for treating chronic herpesvirus infection (HSV) of types I and II. The vaccine was developed at the Research Institute of Virology. DI. Ivanovsky RAMS has been used in the Russian Federation for over 15 years.
Herpes Vaccine Overview
According to the U.S. CDC, the spread of HSV- 1 generally occurs by direct contact, usually involving saliva, and most commonly appears as cold sores in or around the mouth. And HSV-2 infections usually occur after sexual contact, leading to recurring, often painful, genital sores in up to a third of people infected. And there is no cure for herpes.
In 2016, two-thirds of the world's population under 50 — about 3.7 billion people — had herpes simplex virus type 1, which most commonly appears as cold sores in or around the mouth, reported the WHO.
Herpes Vaccines and HIV
People with HSV-2 infection are at least three times more likely to become infected with HIV if exposed. Thus, interventions targeting HSV-2, such as new HSV vaccines, have the potential for additional benefit against HIV, which could be particularly powerful in regions with a high incidence of co-infection.
Content sources: The WHO, US CDC, WHO, NIH, research papers, ClinicalTrials.gov, and the Precision Vaccinations news network. Content is fact-checked by healthcare providers, such as Dr. Robert Carlson.