Phase 4
Completed N=372
Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study
Source: ClinicalTrials.gov NCT01824537 ↗Enrolled (actual)
372
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: HPV Incidence Rates, Expressed as Incident Infections/1000 Infection-months at Risk. These Were Calculated Separately for Females and Males Across the Four Vaccine Assignment Groups. — 1.40; 1.58; 1.05; 1.58 incident infections/1000 infection-month
◆ Published Evidence
Emerging
14citations · ~2 / year
Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.
Summary
Human papillomavirus (HPV) is a member of the Papillomaviridae family of DNA viruses that is capable of infecting humans. HPV infection can cause cancers of the cervix, vulva, vagina, and anus in women or cancers of the anus and penis in men. Two prophylactic vaccines have been proven to be highly effective in preventing the acquisition of HPV infection and the genital precancerous lesions caused by it. However, we do not know yet if a previously infected individual, once vaccinated, would be less infective to her or his sexual partner. We plan to conduct a study, called Transmission Reduction And Prevention with HPV vaccination (TRAP-HPV) study to answer this question. It will include 500 sexually active couples* (total of 1000 individuals) in university student health clinics in Montreal (age 18-45 years). It will be a randomized placebo-controlled, double-blinded intervention trial. Study participants will be followed up to 12 months. Behavioural and biological data will be collected at the time of study enrolment, then at months 2, 4, 6, 9 and 12 post-enrolment. The results of this trial will be invaluable in informing policies regarding vaccination of women and men.
Linked Publications (3)
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Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.
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Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.
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Protection to Self and to One's Sexual Partner After Human Papillomavirus Vaccination: Preliminary Analysis From the Transmission Reduction And Prevention with HPV Vaccination Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HPV Incidence Rates, Expressed as Incident Infections/1000 Infection-months at Risk. These Were Calculated Separately for Females and Males Across the Four Vaccine Assignment Groups. |
1.40; 1.58; 1.05; 1.58; 2.42; 0.99 | — |
Eligibility Criteria
Inclusion Criteria
- Couple must have been in a new relationship that started no more than six months prior to study entry
- Both partners plan on remaining in Montreal for at least 1 year
- Plan on having continued sexual contact with partner
- Be willing to comply with study procedures
Exclusion Criteria
- Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners)
- Any history of cervical, penile, oral or anal cancers
- Being pregnant or plan on immediately becoming pregnant
Data sourced from ClinicalTrials.gov (NCT01824537) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.