Human Papillomavirus (HPV) Vaccines March 2023
Vaccination against human papillomavirus (HPV) is recommended to prevent infections and associated cancers, says the World Health Organization (WHO). As of March 31, 2023, there are effective HPV vaccines that protect males and females against cancers caused by HPV.
These vaccines include 9vHPV, 4vHPV, and/or 2vHPV, says the U.S. Centers for Disease Control and Prevention (CDC). In the U.S., HPV vaccination for adolescents has been recommended for women since 2006 for men since 2011. The current HPV schedule is posted at this link.
HPV Vaccines Approved For 2023
Gardasil - Merck's Gardasil® vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18. Gardasil is highly efficacious in preventing virus types 16 and 18 infections, responsible for approximately 70% of cervical cancer cases globally. In addition, the quadrivalent vaccine is highly efficacious in preventing anogenital warts, a common genital disease caused by infection with HPV types 6 and 11. Unfortunately, Gardasil is not available in Canada.
Gardasil9 - Gardasil 9® consists of HPV proteins, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. HPV infections can lead to certain cervical cancers. Many females with cervical cancer were probably exposed to cancer-causing HPV types in their teens and early 20s. Additionally, males can get HPV, causing anal and throat cancers and genital warts.
Cervarix - GlaxoSmithKline's Cervarix is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18.
Cecolin - Innovax Biotech Co., Ltd.'s Cecolin HPV Vaccine protects women against HPV 16 and 18, two HPV types causing 70 percent of all cervical cancers, the third most common cancer among women. Starting May 18, 2020, the HPV vaccine will be available in Wuhan's provincial Maternity and Child Healthcare Hospital. In addition, it is conducting a phase 3 clinical study.
Walvax Biotechnology's recombinant bivalent HPV vaccine is effective against HPV strains 16 and 18, which China's National Medical Products Administration approved on March 25, 2022.
Cervavac is Serum Institute of India's Quadrivalent Human Papillomavirus vaccine (qHPV) authorized in India for 9 to 26-year-olds, protecting against HPV types 6, 11, 16, and 18. Local availability in 2023.
HPV Vaccine Candidates
RGVax - The U.S. FDA completed its review of the investigational new drug application for its licensed monovalent component HPV16 RG1-VLP and concluded that a Phase 1 clinical trial may proceed as of March 29, 2023. RGVax is a chimeric HPV VLP platform that displays 360 copies of the highly conserved, neutralizing HPV epitope. The underlying RGVax foundational technology was licensed by PathoVax LLC from Johns Hopkins University.
TG4001 - TG4001 is Transgene's vaccine candidate using an attenuated and modified poxvirus as a vector expressing the HPV16 E6 and E7 proteins interleukin-2.
VGX-3100 - Inovio's investigational immunotherapy vaccine includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18.
INO-3107 - INOVIO announced positive interim results from an ongoing Phase 1/2 clinical trial evaluating INO-3107. It showed a statistically significant improvement in the clinical endpoint of the number of surgical interventions needed to control papilloma growth. INO-3107 was also observed to be well-tolerated and immunogenic in the trial.
VTP-200 - Vaccitech's ChAdOx1-HPV immunotherapy for high-risk HPV infection and low-grade cervical intraepithelial neoplasia. The platform has a differentiated ability to induce CD8+ T cells and cells of the immune system that naturally clear HPV-infected cells in cervical tissue. In addition, VTP-200 targets six early proteins from five high-risk HPV groups and therefore covers more types of HPV than any other immunotherapy previously tested. Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 phase 1/2study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint.
HB-201 - HOOKIPA Pharma Inc.'s monotherapy is designed to use an arenavirus backbone (LCMV for HB- 201) while expressing the antigen, an E7/E6 fusion protein derived from HPV16+.
VB10.16 - Nykode Therapeutics is a potential first-in-class off-the-shelf therapeutic cancer vaccine in development to treat HPV16-positive cancers. VB10.16 is currently being investigated in the VB C-02 trial in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer.
REC603 - Jiangsu Recbio Technology's REC603 is a recombinant HPV 9-valent vaccine conducting a phase 3 clinical trial. The REC604a is equipped with the novel adjuvanted BFA04 independently developed by the Company, which aims to reduce the vaccination dose by enhancing the immunogenicity and cross-protection effects. In addition, REC603 adopts the H. polymorpha expression system to achieve high-yield and stable expression of HPV virus-like particles and to make the Company's vaccine candidate more suitable for commercial production at an annual output of 20 million doses.
Defence Therapeutics Inc. developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus.
LinKinVax is conducting a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate in immuno-oncology targeting dendritic cells against head and neck cancer associated with HPV.
Genexine GX-188E (tirvalimogene teraplasmid) is a DNA therapeutic vaccine fused with encoding both E6 and E7 antigens and the extracellular domain of Flt3L to target and activate dendritic cells. A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer.
HPV Vaccination and HIV
A peer-reviewed study published on October 1, 2022, found MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with prior gonococcal infection.
HPV Vaccine Effectiveness
Lauri E. Markowitz, M.D. Division of Viral Diseases, U.S. CDC Advisory Committee on Immunization Practices presented on June 23, 2022, which summarized: 'There are now data on 1-dose HPV vaccination, including efficacy data from a randomized controlled trial with 18-month follow-up. In addition, long-term follow-up from other studies suggests a good duration of protection (>10 years) with one dose. And Julia Gargano, Ph.D., presented: 'Impact of the US HPV vaccination program on HPV-associated outcomes. Declines in HPV16/18 prevalence have translated into declines in cervical precancer incidence in young women.'
The UK's Joint Committee on Vaccination and Immunisation announced on August 5, 2022, that one HPV dose is as effective as two at preventing cancers caused by HPV in adolescents. Likewise, on April 11, 202, the WHO's Strategic Advisory Group of Experts on Immunization concluded that a single-dose HPV vaccine delivers virus protection comparable to 2-dose schedules.
A systematic review of 138 peer-reviewed studies, published between March 2016 and March 2020, within MEDLINE, EMBASE, and Google Scholar involving 14 years of follow-up data details the impact and effectiveness of GARDASIL through immunization programs in 23 countries across Africa, Asia, Europe, Australia, South America, and North America. The most significant reductions were observed in younger age groups (14-17 years), with up to 73% reduction in CIN3+ among vaccinated females. Consistent with previous reviews, declines in the incidence of anogenital warts continue to be observed within vaccine-targeted female age groups, with more significant decreases (up to 88%) observed in younger age groups.
HPV Vaccine Price
The list price for each indicated dose of GARDASIL 9 is about $250, says Merck. The U.S. CDC Vaccine Price List - Vaccines for Children Program - was last updated in September 2022. HPV vaccine prices and discount information are posted at InstantRx™.
HPV Antibody Therapy
SELLAS Life Sciences Group, Inc. anti-PD-1 antibody nivolumab (Opdivo®) in patients with relapsed WT1-expressing ovarian cancers phase 1 study results were published in the journal Cancers in February 2023.
Sexually Transmitted Disease Vaccines
The sexually transmitted disease vaccine summary was updated in February 2023.
HPV Vaccine News 2023
February 15, 2023 - ANI reported the Central Drugs Laboratory had released approximately 80,000 doses of the Cervavac HPV vaccine in Kasauli, Himachal Pradesh, India.
January 24, 2023 - SSI's Cervavac vaccine became available in India, with an international launch scheduled for 2024.
January 20, 2023 - The Korean Ministry of Food and Drug Safety issued Fast Track Designation for GX-188E.
January 19, 2023 - LinKinVax announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with HPV.
January 11, 2023 - A study published by the American Cancer Society indicates cervical cancer herd immunity may occur in the U.S. Latest data shows improvements in cervical cancer rates are linked to HPV vaccinations.
January 11, 2023 - The Open Forum Infectious Diseases published a study that concluded - The available evidence demonstrates that HPV vaccination in mid-adults is safe, efficacious, and likely to benefit both HPV-naïve mid-adults and those with previous infections. This study concluded universal mid-adult HPV vaccination in the U.S. could avert over 20,000 cancer cases over 100 years, costing more than $141,000 per quality-adjusted life-year gained.
CONTENT SOURCES: World Health Organization, US Centers for Disease Control and Prevention, FDA, research studies, manufacturer announcements, and the Precision Vax news network, reviewed by healthcare providers, such as Dr. Bob Carlson.