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

NCT ID: NCT04953130

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 10400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Male vaccination + national HPV vaccination programme

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

Group Type: EXPERIMENTAL

Gardasil® HPV vaccine

Intervention Type: 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).

National HPV vaccination programme only

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

Group Type: ACTIVE_COMPARATOR

Gardasil® HPV vaccine

Intervention Type: 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).

Interventions

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).

Intervention Type: BIOLOGICAL

Other Intervention Names

4-valent HPV vaccine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mwanza Intervention Trials Unit, National Institute for Medical Research

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Cancer Epidemiology Research Programme Institut Català d' Oncologia

UNKNOWN

Sponsor Role: collaborator

Karolinska Institute Department of Laboratory Medicine

UNKNOWN

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mwanza Intervention Trials Unit

Mwanza, , Tanzania

Countries

Tanzania

Other Identifiers

MITU-003

Identifier Type: -

Identifier Source: org_study_id