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Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study

NCT01824537 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2025-03-19

Study results available
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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.

Conditions

  • Human Papillomavirus Infection

Interventions

BIOLOGICAL

HPV vaccine, Gardasil 9

Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).

BIOLOGICAL

Hepatitis A vaccine

Provided by Sanofi Pasteur.

Sponsors & Collaborators

Principal Investigators

  • Mariam El-Zein, PhD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2022-11-18
Completion
2022-11-18

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824537 on ClinicalTrials.gov