Gonorrhea Vaccines 2023
The World Health Organization (WHO) published guidance for gonorrhea vaccine development in November 2021 and testing in July 2023. As of November 2023, no vaccines are approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for preventing gonorrhea infection. A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that the Outer Membrane Vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29. These results are consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea.
The U.S. Centers for Disease Control and Prevention (CDC) reported about 710,000 cases of gonorrhea in 2021, making it the second most common sexually transmitted infection (STI) in the U.S. In addition, the CDC announced on April 11, 2023, that gonorrhea rates increased by more than 4%, reaching 710,151 in 2022. During March–April 2023, several EU/EEA countries reported increases in gonorrhea notifications, which started in 2022.
Repurposed Vaccines Against Gonorrhea
On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) advised the government of a routine targeted vaccination program to prevent gonorrhea. The JCVI agreed that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection. In addition, a modeling study indicated that vaccinating at-risk people could prevent 110,000 gonorrhea cases in England. Meningococcal (MenB-4C, Bexsero) vaccination is recommended in France against Gonorrhea.
On February 19, 2023, Mark Mascolini reported a meningococcal vaccine (4CMenB) continued to cut the risk of STIs in MSM using preexposure prophylaxis (PrEP) in the DOXYVAC trial. A study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection. Clinical studies (April 22) published in the Lancet Infectious Diseases reported that two doses of the 4CMenB vaccine were around 33% to 40% effective against gonorrhea in adolescents and young adults.
Gonorrhea Vaccine Candidates
GSK announced on June 27, 2023, that the U.S. FDA had granted a Fast Track designation for its Neisseria gonorrhea investigational vaccine (NgG), which started in November 2022, will enroll approximately 750 subjects from the U.S., UK, France, Germany, Spain, Brazil, Philippines, South Africa. The trial conducted by GSK is a Phase I/II first-time in-human study evaluating the vaccine candidate's safety and efficacy in individuals aged 18-50 years old, regardless of previous gonorrhea history. Phase I of the study was an FTiH dose-escalation safety lead-in conducted in healthy adults, which was completed. The Phase II segment of the study is ongoing and aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.
Intravacc's Avacc 11® is the prophylactic intranasal gonorrhea candidate vaccine being developed in partnership with Therapyx Inc. Clinical study results were published in the journal MSphere of the American Society of Microbiology in December 2022. In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further.
UMass Chan Medical School received a U.S. National Institutes of Health (NIH) grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion. A report was published in the journal mBio in 2019.
Gonorrhea can be treated with antibiotics; however, the bacteria have developed resistance to some treatments, and treatment will not repair any permanent damage done by the disease, says the U.S. Centers for Disease Control and Prevention (CDC). On November 1, 2023, the journal Nature published an article: The potential new super gonorrhea treatment, called zoliflodacin, developed initially by drug firm AstraZeneca and later by its spin-off Entasis Therapeutics, targets an essential bacterial enzyme that untangles DNA during cell replication. Zoliflodacin has a unique mechanism of action that inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.
The WHO announced on July 24, 2023, that the spread of a Neisseria gonorrhea clone highly resistant to ceftriaxone is increasingly being reported in various countries. According to the United Kingdom, on June 6, 2023, gonorrhea diagnoses increased to 82,592 in 2022, an increase of 50.3% in one year. This is the most significant number of gonorrhea diagnoses in any one year since records began in 1918.
The NEJM journal published Original Research on April 6, 2023, that found the incidence of gonorrhea was low with doxycycline postexposure prophylaxis. The Lancet Infectious Disease wrote on June 12, 2023, that there is increasing evidence that doxycycline post-exposure prophylaxis (doxy-PEP) effectively prevents sexually transmitted infections among high-risk patients, particularly in patients using HIV preexposure prophylaxis. Overall, the risk of selecting dual-resistant strains and increasing N gonorrhea ceftriaxone resistance must be carefully balanced against the benefits of using doxy-PEP to prevent and treat sexually transmitted infections. The randomized phase of the DOXYVAC clinical study was stopped in August 2022 when DoxyPEP, a U.S. study presented at the International AIDS Conference, found that doxycycline PEP cut the risk of gonorrhea by 55%. In California, doxy-PEP is recommended for certain people.
According to a study in the Journal of Infectious Diseases published in July 2023, gonorrhea infections in China are showing decreasing susceptibility and high resistance to penicillin (75.2%), tetracycline (87.9%), ciprofloxacin (98.3%), ceftriaxone (8.9%), cefixime (14.3%) and azithromycin (8.6%) in 2021. On June 23, 2023, the Journal of Antimicrobial Chemotherapy published research: Genomic surveillance and antimicrobial resistance determinants in Neisseria gonorrhoeae isolates from Uganda, Malawi, and South Africa, 2015–20, that reported the high prevalence of resistance to ciprofloxacin (and empirical use continues), tetracycline and benzylpenicillin, and the emerging resistance determinants for azithromycin show it is imperative to strengthen the gonococcal AMR surveillance, ideally including genomics, in African countries.
The Cleveland Clinic has said antibiotic-resistant gonorrhea could play a role in specific rising STD rates, a situation the CDC has called "an urgent public health threat." This concept of post-exposure prophylaxis was first evaluated in the ANRS IPERGAY phase 3 clinical trial, which demonstrated that doxycycline, when used within 72 hours after sexual intercourse, led to an approximately 70% reduction in the risk of infection with chlamydia and syphilis, which is caused by the bacterium Treponema pallidum. The Global Antibiotic Research & Development Partnership and Innoviva Specialty Therapeutics announced on May 23, 2023, the completion of recruitment for their global phase 3 pivotal registration trial of oral zoliflodacin, an investigational, first-in-class antibiotic being developed for the treatment of uncomplicated gonorrhea infection in patients.
On November 15, 2923, the U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test for use in adult patients ages 18 years and older. LetsGetChecked is the first OTC diagnostic test for gonorrhea with at-home sample collection to be granted marketing authorization. Before today's authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor's office.
Gonorrhea Vaccine News 2023
November 10, 2023 - The U.K.'s Joint Committee on Vaccination and Immunisation published an Independent Report agreeing that a targeted program should be initiated using the 4CMenB vaccine for the prevention of gonorrhea in those who are at most significant risk of infection.
August 31, 2023 - Researchers with the Oregon Public Health Division suggest that the meningococcal group B vaccine may offer protection against gonorrhea infection.
June 27, 2023 - GSK plc announced today the US FDA has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine.
April 29, 2023 - Gonorrhea Risk Reduced with Oral Antibiotic.
April 11, 2023 - The U.S. CDC published - U.S. STI Epidemic Showed No Signs of Slowing in 2021 – Cases Continued to Escalate.
February 22, 2023 - Medscape reported: Meningococcal Vaccine Shows Benefit in STI Prevention.
February 17, 2023 - Promising gonorrhea vaccine may prevent 40% of cases.
January 19, 2023 - The Massachusetts Department of Public Health announced it detected a novel strain of gonorrhea in a resident and, for the first time, showed that resistance or reduced response to five classes of antibiotics has been identified in gonorrhea in the U.S. This gonorrhea strain had been seen in Asia-Pacific countries and the U.K. A genetic mark common to these Massachusetts cases was previously seen in a case in Nevada.
January 16, 2023 - Intravacc announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed with Therapyx Inc. Dr. Jan Groen, Intravacc's CEO, commented, "This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments."
December 20, 2022 - mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria gonorrhoeae.
September 29, 2022 - The UMass Chan Medical School received a U.S. NIH grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion, a clinical-stage biotech company in Denmark.
July 27, 2022 - Aidsmap published: Taking antibiotic after sex cuts STIs by two-thirds, 'DoxyPEP' study finds.
April 12, 2022 - The Lancet published: Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea: a retrospective observational study. MenB-4C vaccination was associated with a reduced gonorrhea prevalence and could offer cross-protection against Neisseria gonorrhoeae.
April 11, 2022 - The journal Frontiers published: Recent Progress Towards a Gonococcal Vaccine.
January 4, 2022 - The NEJM published Eliminating gonorrhea with a Vaccine?