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
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus Infection||Biological: HPV vaccine, Gardasil 9 Biological: Hepatitis A vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
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
|Contact: Allita Rodriguesemail@example.com|
|McGill University - Division of Cancer Epidemiology||Recruiting|
|Montreal, Quebec, Canada, H4A 3T2|
|Contact: Allita Rodrigues 514-398-8191 firstname.lastname@example.org|
|Contact: Anna Tzagourni (514) 398-8014 email@example.com|
|Principal Investigator: Eduardo L Franco, DrPH|
|Study Director:||Mariam El-Zein, PhD||McGill University|