Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania

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.

NCT Number	NCT04953130
Lead Sponsor	London School of Hygiene and Tropical Medicine Collaborators: Mwanza Intervention Trials Unit, National Institute for Medical Research, York Biomedical Research Institute, Hull York Medical School, University of York, Cancer Epidemiology Research Programme Institut Català d' Oncologia, Karolinska Institute Department of Laboratory Medicine, University of Cambridge
Conditions	HPV Infection, Vaccine Preventable Disease
Enrollment	10,400 participants
Start Date	2022-08-01
Primary Completion	2025-11 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2025-09-10