A randomised, observer-blind, non-inferiority trial to evaluate alternative human papillomavirus vaccination schedules in young females in West Africa
Medical Research Council
London School of Hygiene and Tropical Medicine
The trial will investigate the potential future utility of alternative HPV vaccination schedules in West Africa. The schedules aim to reduce the financial and logistical burden of HPV vaccine rollout and to provide new opportunities to optimise coverage. The following questions will be addressed: 1. Does the administration of 1 or 2 doses of a quadrivalent HPV vaccine (qHPV) result in lower type-specific seroconversion rates in 9 to 12 year old females in West Africa compared to a 3 dose schedule? 2. Does the administration of 2 doses of qHPV result in lower type-specific seroconversion rates in 4 to 8 year old females in West Africa compared to 3 doses in 9 to 12 year old females? 3. What are the long term health and economic implication of a reduced dose schedule and/or a younger age of routine vaccination in a low income West African setting? A randomised, observer-blind, non-inferiority trial will be undertaken. 9 to 12 year old females will be randomised to receive 1, 2 or 3 doses of a qHPV over up to six months. An additional group of 4 to 8 eight year old females will be recruited and will receive two doses of qHPV. The following outcome measures will be examined: Primary: - HPV types 16 and 18 neutralising antibody seroconversion rates at 7 months Secondary: - HPV types 16 and 18 neutralising antibody seropositivity rates at 12, 24 and 48 months - HPV types 16 and 18 neutralizing antibody GMT at 7, 12, 24 and 48 months - HPV types 16 and 18 antibody avidity at 7, 12, and 48 months Exploratory: HPV specific B-cell and T-cell responses will also be examined in a sub-set of subjects A sample size of 256 participants per group is based on a reference 3 dose seroconversion rate of 99% and a noninferiority margin of 5%. The figure provides over 90% power to determine the non-inferiority of the primary outcome measure using a 1-sided alpha of 1.25% allowing for multiplicity two HPV types and an attrition rate of up to 10%.
6.1 Pharmaceuticals / Research Grant