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

NCT04953130 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: MITU-003
• Study Type: interventional
• Target: 10,400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Impact of adding single-dose male HPV vaccination to the national HPV vaccination programme in girls on population 4-valent HPV genotype prevalence in 18 to 21-year-old females and males

  Prevalence of 4-valent vaccine HPV genotype DNA (HPV 6, 11, 16 or 18) in males and females aged 18 to 21 years in intervention clusters and control clusters 36 months post-male vaccination

  Month 36

Secondary Outcomes (5)

• Immunogenicity and safety of single dose 4-valent HPV vaccination in boys

  Month 12, 24 and 36

• Impact of female-only vaccination through the national vaccination programme on population HPV prevalence in 18 to 21-year-old males and females

  Month 36

• Uptake of dose 1 and coverage of dose 2 in eligible target groups for the national HPV vaccination programme;

  Month 36

• Acceptability of a gender-neutral approach to HPV vaccination

  Month 24

• Cost-effectiveness of adding a multi-year single dose male HPV vaccination strategy to the national female HPV vaccination programme

  Month 36

Study Arms (2)

Male vaccination + national HPV vaccination programme

EXPERIMENTAL

Single dose of the 4-valent HPV vaccine (Gardasil®; Merck \& Co.) offered to all eligible boys aged 14 to 18 years in the 13 intervention communities. Girls aged 14 years are offered 2 doses of Gardasil® through the Tanzanian national HPV vaccine programme

Biological: Gardasil® HPV vaccine

National HPV vaccination programme only

ACTIVE COMPARATOR

Girls aged 14 years are offered 2 doses of Gardasil® through the Tanzanian national HPV vaccine programme

Biological: Gardasil® HPV vaccine

Interventions

Gardasil® HPV vaccine BIOLOGICAL

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).

Also known as: 4-valent HPV vaccine

Male vaccination + national HPV vaccination programme; National HPV vaccination programme only

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parents and adult male participants (aged 18 years) must sign an ICF and male participants aged less than 18 years must sign an informed assent form (IAF), indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to receive HPV vaccination. If the parent or participant cannot read or write, the procedures must be explained and informed consent/assent must be witnessed by a literate third party who is not involved in the conduct of the study.
• Participants must have been born male, and must be aged 14 to 18 years inclusive at time of vaccination.
• Participants must be living in an intervention community (cluster).
• Participants must be willing and able to comply with the protocol requirements.
• Participants must agree to avoid all non-trial immunisations in the 14 days following vaccination with the trial vaccine, other than emergency vaccinations such as post-exposure rabies or tetanus vaccinations.
• Participants must be healthy as determined by a medical history. A physical examination will be conducted if necessary according to the clinician's judgement.

You may not qualify if:

• Boys will be excluded from HPV vaccination if:
• They have previously been vaccinated against HPV.
• They have a history of allergy or anaphylaxis to one or more of the HPV vaccine components, to yeast or to latex.
• They are enrolled in another vaccine research study that specifically specifies that they must not participate in a study of another vaccine
• They have been diagnosed with a chronic condition (except HIV, as per the comment above), such as an autoimmune condition, sickle cell disease, degenerative disease, neurologic or genetic disease, among others;
• There are significant conditions or clinically significant findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., it would compromise their safety or well-being).

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Mwanza Intervention Trials Unit, National Institute for Medical Research: collaborator
• York Biomedical Research Institute, Hull York Medical School, University of York: collaborator
• Cancer Epidemiology Research Programme Institut Català d' Oncologia: collaborator
• Karolinska Institute Department of Laboratory Medicine: collaborator
• University of Cambridge: collaborator

Study Sites (1)

Mwanza Intervention Trials Unit

Mwanza, Tanzania

Location

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised trial with 26 communities (13 per arm)

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: August 1, 2022
• Primary Completion: November 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-03

Locations

TA (1)