MedTrace Logo

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

NCT04953130 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10400

Last updated 2025-09-10

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Mwanza Intervention Trials Unit, National Institute for Medical Research

    collaborator UNKNOWN

  • York Biomedical Research Institute, Hull York Medical School, University of York

    collaborator UNKNOWN

  • Cancer Epidemiology Research Programme Institut Català d' Oncologia

    collaborator UNKNOWN

  • Karolinska Institute Department of Laboratory Medicine

    collaborator UNKNOWN

  • University of Cambridge

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-11-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04953130 on ClinicalTrials.gov