Randomised trial of two versus three doses of HPV vaccine in India, converted to a cohort study of one, two and three doses
- Population
- Girls aged 10-18 years vaccinated between September 2009 and April 2010; follow-up median 9.0 years (IQR 8.2-9.6).
- Design
- A randomised trial comparing three and two doses of quadrivalent HPV vaccine (Gardasil) in unmarried girls aged 10-18 years from nine centres in India was converted to a cohort study after the Indian Government suspended HPV vaccination in trials. Participants were allocated to cohorts by doses received per protocol (two-dose, three-dose, two-dose default with 3452 girls, and a single-dose default cohort); the single-dose group was therefore not a randomised arm. Arm roles follow the paper's revised aim: the single-dose group is listed as experimental and the two- and three-dose cohorts as controls for that comparison; unvaccinated age-matched women served as the reference for vaccine efficacy and are not listed as an arm. Vaccine efficacy was adjusted for imbalance in potential confounders. ClinicalTrials.gov lists the study as Randomised Trial of Two Versus Three Doses (allocation non-randomized) and records an enrolment of 22,729; the paper reports 4348 girls with three doses, 4980 with two doses and 4949 with one dose.
- Primary endpoint
- Persistent HPV infection
- Arms
- Single dose (default cohort) (experimental, n = 4,949): One dose of quadrivalent HPV vaccine
- Two doses (0 and 6 months) (control, n = 4,980): Two doses of quadrivalent HPV vaccine
- Three doses (control, n = 4,348): Three doses of quadrivalent HPV vaccine
- People
- Basu P, senior author Sankaranarayanan R
Appears in
Sources
Basu P, Malvi SG, Joshi S, Bhatla N, Muwonge R, Lucas E, et al. Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study. Lancet Oncol. 2021;22(11):1518-1529.