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

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ClinicalTrials.gov Identifier: NCT01824537
Recruitment Status : Recruiting
First Posted : April 4, 2013
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Eduardo Franco, McGill University

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Biological: HPV vaccine, Gardasil 9 Biological: Hepatitis A vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study: A Randomized Controlled Trial of the Efficacy of HPV Vaccination in Preventing Transmission of HPV Infection in Heterosexual Couples
Study Start Date : September 2013
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis A

Arm Intervention/treatment
Active Comparator: HPV vaccine, Gardasil 9
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
Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).

Placebo Comparator: Hepatitis A vaccine
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
Provided by Sanofi Pasteur.
Other Name: Avaxim




Primary Outcome Measures :
  1. The primary outcome will be the reduction of HPV DNA positivity for the target HPV vaccine types (i.e., HPVs 6, 11, 16, and 18) in multiple anatomic sites in the placebo-treated sexual partners of persons who received Gardasil. [ Time Frame: At months 2, 4, 6, 9 and 12. ]
    Reduction in HPV type concordance (for the four target types) will be the main outcome evaluable as per the above group contrasts. These comparisons will be done with due attention to the enrolment virological status of the individuals. For instance, it is expected that a Avaxim-treated woman who is positive for HPV 6 in the oral specimen but negative for this type in the vaginal specimen may derive benefit if her partner receives Gardasil, even if he is HPV-6 positive in the penile sample. The assumption is that protection via vaccination is pan-mucosal, via transudation of neutralizing antibodies; this protection may mediate transmission.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824537


Contacts
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Contact: Allita Rodrigues 514-398-8191 allita.rodrigues@mcgill.ca

Locations
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Canada, Quebec
McGill University - Division of Cancer Epidemiology Recruiting
Montreal, Quebec, Canada, H4A 3T2
Contact: Allita Rodrigues    514-398-8191    allita.rodrigues@mcgill.ca   
Contact: Anna Tzagourni    (514) 398-8014    canepiadm.med@mcgill.ca   
Principal Investigator: Eduardo L Franco, DrPH         
Sponsors and Collaborators
McGill University
Investigators
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Study Director: Mariam El-Zein, PhD McGill University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Eduardo Franco, James McGill Professor and Chair, Department of Oncology; Director, Division of Cancer Epidemiology, McGill University
ClinicalTrials.gov Identifier: NCT01824537    
Other Study ID Numbers: CIHR-MOP-125949
IIS #38265 ( Other Grant/Funding Number: Merck )
MOP-125949 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
FDN-143347 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Keywords provided by Dr. Eduardo Franco, McGill University:
Human papillomavirus (HPV)
Vaccination
Cervical cancer prevention
Herd immunity
Additional relevant MeSH terms:
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Infection
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs