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

NCT01824537 | Completed Phase 4 Results DMC

• 4 other identifiers: CIHR-MOP-125949IIS #38265MOP-125949FDN-143347
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Human papillomavirus (HPV); Vaccination; Cervical cancer prevention; Herd immunity

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants (n=308) from new (≤6 months) heterosexual couples aged 18+ in Montreal, Canada, were randomized into 4 groups: Group 1: 40 males and 40 females; Group 2: 31 males and 31 females; Group 3: 39 males and 39 females; Group 4: 44 males and 44 females. Genital samples, collected at 0, 2, 4, 6, 9, and 12 months, were genotyped for 36 HPV types. For females and males separately within each of the 4 groups, we calculated, via time-to-event analyses, the incidence rates (and their jackknife 95% confidence intervals, CI) as the number of incident infections/1000 infection-months at risk. We used type-specific HPV infections as the unit of analysis; that is, each participant could contribute time at risk for up to the 9 vaccine-targeted (i.e., HPVs 6, 11, 16, 18, 31, 33, 45, 52, and 58) type-specific HPV-level infections. Participants contributed time at risk for incidence of type-specific HPV-level infections if they had not previously tested positive for that HPV type.

  Up to 12 months

Study Arms (2)

HPV vaccine, Gardasil 9

ACTIVE COMPARATOR

HPV vaccine intervention: The intervention vaccine will be Gardasil 9, a 9-valent vaccine by Merck. This vaccine was chosen because it allows for the observation of 9 HPV outcomes (HPV 6, 11, 16 and 18) (the other available vaccine, Cervarix, protects against HPVs 16 and 18, only).

Biological: HPV vaccine, Gardasil 9

Hepatitis A vaccine

PLACEBO COMPARATOR

The placebo comparator will be Avaxim, by Sanofi Pasteur. This control vaccine was chosen because hepatitis A immunization provides a similar health prevention incentive as HPV vaccination to study participants while preserving the scientific cogency of a "placebo" comparator. Gardasil 9 requires administration of 3 doses, while Avaxim only requires 2 doses. For this reason, a placebo injection (saline solution) will be added in between the Avaxim vaccination regimen. Consequently, both treatment and control vaccines will have similar regimens, i.e., study entry, 2 months, and 6 months.

Biological: Hepatitis A vaccine

Interventions

HPV vaccine, Gardasil 9 BIOLOGICAL

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

HPV vaccine, Gardasil 9

Hepatitis A vaccine BIOLOGICAL

Provided by Sanofi Pasteur.

Also known as: Avaxim

Hepatitis A vaccine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University - Division of Cancer Epidemiology

Montreal, Quebec, H4A 3T2, Canada

Location

Related Publications (3)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

• MacCosham A, El-Zein M, Burchell AN, Tellier PP, Coutlee F, Franco EL; TRAP-HPV study group. 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. Sex Transm Dis. 2022 Jun 1;49(6):414-422. doi: 10.1097/OLQ.0000000000001620. Epub 2022 Mar 2.

  PMID: 35235550 DERIVED

• MacCosham A, El-Zein M, Burchell AN, Tellier PP, Coutlee F, Franco EL. 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. BMJ Open. 2020 Aug 11;10(8):e039383. doi: 10.1136/bmjopen-2020-039383.

  PMID: 32788190 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Papillomavirus Vaccines; Human Papillomavirus Recombinant Vaccine nonavalent; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines

Results Point of Contact

• Title: Eduardo L Franco
• Organization: McGill University

eduardo.franco@mcgill.ca

514-398-6032

Study Officials

• Mariam El-Zein, PhD

  McGill University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James McGill Professor and Chair, Department of Oncology; Director, Division of Cancer Epidemiology

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: January 1, 2014
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Locations

CA (1)