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ACTIVE NOT RECRUITING
NCT04953130
PHASE4

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

Sponsor: London School of Hygiene and Tropical Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

14 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

10400

Start Date

2022-08-01

Completion Date

2026-10

Last Updated

2025-09-10

Healthy Volunteers

Yes

Interventions

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).

Locations (1)

Mwanza Intervention Trials Unit

Mwanza, Tanzania