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Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania (Add-Vacc)
Add-Vacc is an unblinded cluster-randomised trial (CRT) with two arms: (i) the national HPV vaccination programme (girls aged \~14 years, control arm) and (ii) the national programme plus single-dose male HPV vaccination given to a multi-year cohort of boys (intervention arm). The CRT will be conducted in 26 communities/clusters (13 per arm) in northern Tanzania. Boys aged 14 to 18 years in the intervention arm will receive one dose of the 4-valent HPV vaccine (Gardasil®) that protects against HPV 6, 11, 16, and 18. Population genital HPV prevalence in 18 to 21-year-olds will be compared between intervention clusters (female and male vaccination) and control clusters (female vaccination only) at 3 years after the intervention. Blood sampling for immune responses and adverse event data collection will be performed in a subset of 200 male subjects in selected intervention clusters.
Details
| Lead sponsor | London School of Hygiene and Tropical Medicine |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 10400 |
| Start date | 2022-08-01 |
| Completion | 2026-10 |
Conditions
- HPV Infection
- Vaccine Preventable Disease
Interventions
- Gardasil® HPV vaccine
Primary outcomes
- Impact of adding single-dose male HPV vaccination to the national HPV vaccination programme in girls on population 4-valent HPV genotype prevalence in 18 to 21-year-old females and males — Month 36
Prevalence of 4-valent vaccine HPV genotype DNA (HPV 6, 11, 16 or 18) in males and females aged 18 to 21 years in intervention clusters and control clusters 36 months post-male vaccination
Countries
Tanzania