One shot for boys could slash HPV in tanzania
NCT ID NCT04953130
First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study in Tanzania tests whether giving boys a single dose of the HPV vaccine (Gardasil) can lower HPV infections in the community. Over 10,000 participants in 26 communities will be split: some communities vaccinate only girls (as usual), while others also vaccinate boys aged 14-18. After 3 years, researchers will compare HPV rates in young adults to see if adding boys makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gardasil® HPV vaccine (4-valent)
- What this could lead to
- If successful, this could show that vaccinating boys with a single dose helps reduce HPV infections in the whole community, supporting broader vaccination programs.
- What could go wrong
- This is a large trial but results depend on community participation and follow-up. The single-dose approach may not provide long-lasting protection, and the study only measures impact after 3 years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 10,400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 18 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mwanza Intervention Trials Unit
RECRUITINGMwanza, Tanzania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New immune therapy aims to train body to clear HPV
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- New Self-Sampling and digital colposcopy could speed up cervical cancer detection
- Could a smaller HPV vaccine dose still protect adults?