Phase 4
N=372
Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study
Human Papillomavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01824537 ↗Enrolled (actual)
372
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: 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 incident infections/1000 infection-month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HPV vaccine, Gardasil 9 (Biological); Hepatitis A vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- McGill University
- Primary completion
- Nov 2022
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 | — |
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.
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). 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.