Male HPV vaccination added to girls’ program in Tanzania

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this unblinded cluster-randomised trial, 26 communities are assigned to either the standard female vaccination program or the female program plus a single-dose Gardasil vaccination for boys. The study compares genital HPV prevalence in 18–21-year-olds between the two arms three years after vaccination, with a subset of 200 boys providing blood samples for immune response and safety data. Vaccination is delivered in schools or community settings, and participants are followed under local ethical guidelines with informed consent/assent. The trial focuses on practical implementation in a real-world national program and gathers safety and immunogenicity information.

Why it matters

Who can join: the full rules

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).

Where it's running

• Mwanza Intervention Trials Unit
  Mwanza, Tanzania Recruiting

Study contacts

• Study coordinator: Deborah Watson-Jones, MD, PhD
• Email: deborah.watson-jones@lshtm.ac.uk

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.