NCT04953130

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10,400 (estimated)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: Male
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HPV Infection
• Vaccine Preventable Disease

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil® HPV vaccine	Single dose 4-valent HPV vaccine in males. Gardasil®, manufactured by MSD, consists of a licensed prophylactic virus-like particle (VLP) vaccine that protects against 4 HPV genotypes (HPV 6, 11, 16, 18).

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-11-01
• Completion: 2026-10-01
• First posted: 2021-07-07
• Last updated: 2025-09-10

Locations

1 site across 1 country: Tanzania

Regulatory

• FDA-regulated drug study