An HPV vaccine from India: broadening possibilities for cervical cancer control
Mené entre 2018 et 2021 sur 2 307 personnes et 699 témoins, cet essai randomisé multicentrique de phase II/III évalue, chez les enfants de 9 à 14 ans, l'immunogénicité et la sécurité d'un vaccin quadrivalent contre le papillomavirus humain (ciblant les types HPV 6, 11, 16 et 18) développé en Inde
In The Lancet Oncology, Hitt Sharma and colleagues 1 report findings from a pivotal phase 2/3 human papillomavirus (HPV) prophylactic vaccine trial. Briefly, they show that two doses of a quadrivalent virus-like particle (VLP) vaccine targeting HPV types 6, 11, 16, and 18 (Cervavax; Serum Institute of India, Pune, India) induced non-inferior antibody responses in girls and boys aged 9–14 years compared with a quadrivalent HPV vaccine licensed worldwide and targeting the same HPV types (Gardasil; Merck Sharp & Dohme, Harleem, the Netherlands), given in three doses to women aged 15–26 years, an age group in which strong clinical efficacy has been shown. A comparison of antibody responses between the two vaccines in men and women aged 15–26 years will be reported separately. The authors also reported no significant differences in adverse events after vaccination of girls and boys aged 9–14 years vaccinated with the new quadrivalent vaccine versus girls vaccinated with Gardasil. Importantly, these findings have led to the licensure of the vaccine by the Drugs Controller General of India. 2 It is the first vaccine manufactured in India to receive such approval, with large implications for future vaccine uptake and HPV-associated cancer prevention in young people in India.