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

Study acronym: Add-Vacc
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Nov 2025 → Dec 2026
See other at-risk trials from London School of Hygiene and Tropical Medicine

Record History

  1. Primary completion pushed from Nov 2025 to Dec 2026
    • Enrollment reopened
    • Study completion pushed from Oct 2026 to Dec 2026
    • Site details revised
    v5
  2. 2 versions Re-verified since Oct 4, 2023, no change to tracked fieldsv3-v4
  3. Start date changed from estimate of Nov 2021 to Aug 1, 2022
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study completion date: Apr 2026 to Oct 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 HPV Infection, Vaccine Preventable Disease
Related terms Papillomavirus Infections, Vaccine-Preventable Diseases
Enrollment 10,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov