Data from Pharmawand - Curated by Marshall Pearce - Date added 12 October 2017
Merck Inc.,, announced results from final analyses of the pivotal Phase III efficacy, immunogenicity, and safety clinical trial for Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant). The data, which showed sustained efficacy for up to six years in the per protocol population, were presented during an oral session at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) congress in Amsterdam, Netherlands. Gardasil 9 is a vaccine indicated for use in girls and women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11. Gardasil 9 is also indicated for use in boys and men 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11.
Gardasil 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant].
These final analyses evaluated study outcomes, including efficacy for up to six years following receipt of first vaccine dose, and antibody responses over five years. Vaccination impact on cervical cytology abnormalities and related therapeutic procedures were also reported. These final analyses are from the base study; a study extension is ongoing to evaluate long term follow-up for an additional 10 years following the end of the base study.
In these analyses at six years, efficacy for Gardasil 9 against HPV31/33/45/52/58-related cervical pre-cancers (cervical intraepithelial neoplasia Grade 3 (CIN 3) was 100 percent (95% CI: 39·4, 100) in the per-protocol population. Efficacy against HPV type 31/33/45/52/58-related cervical, vulvar, and vaginal disease, persistent infection, cervical cytological abnormalities; cervical biopsy; and cervical definitive therapy ranged from 90-98 percent. Incidence of HPV6/11/16/18-related persistent infection, disease, cytological abnormalities, and procedures was similar in recipients of Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and Gardasil 9 [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant].
Gardasil 9 produced similar antibody protection against the four HPV types in Gardasil. Antibodies to the HPV types targeted by Gardasil 9 persisted through five years following vaccination. Geometric mean titer ratios Gardasil 9/Gardasil) for HPV6/11/16/18 varied minimally over time. The two vaccines had similar adverse event profiles; injection-site adverse events were more common with Gardasil 9; most were mild-to-moderate in intensity. A paper detailing these results was also published online on September 5 in The Lancet.