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Cancer Vaccine

HPV vaccine, Gardasil 9 for Human Papillomavirus (TRAP-HPV Trial)

Phase 4
Waitlist Available
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at months 2, 4, 6, 9 and 12.
Awards & highlights

TRAP-HPV Trial Summary

This trial will help us determine if the HPV vaccine also protects against transmitting the virus to others, not just the person vaccinated.

Eligible Conditions
  • Human Papillomavirus

TRAP-HPV Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at months 2, 4, 6, 9 and 12.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at months 2, 4, 6, 9 and 12. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The 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.

TRAP-HPV Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HPV vaccine, Gardasil 9Active Control1 Intervention
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).
Group II: Hepatitis A vaccinePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor
394 Previous Clinical Trials
997,381 Total Patients Enrolled
Mariam El-Zein, PhDStudy DirectorMcGill University
1 Previous Clinical Trials
1,225 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BMJ OpenJournal
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
MacCosham, Aaron, Mariam El-Zein, Ann N Burchell, Pierre-Paul Tellier, François Coutlée, and Eduardo L Franco. 2020. “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. BMJ. doi:10.1136/bmjopen-2020-039383.
Sexually Transmitted DiseasesJournal
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
MacCosham, Aaron, Mariam El-Zein, Ann N. Burchell, Pierre-Paul Tellier, François Coutlée, Eduardo L. Franco, and for the TRAP-HPV study group. 2022. “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”. Sexually Transmitted Diseases. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/olq.0000000000001620.
Sexually Transmitted DiseasesJournal
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
MacCosham, Aaron, Mariam El-Zein, Ann N. Burchell, Pierre-Paul Tellier, François Coutlée, Eduardo L. Franco, and for the TRAP-HPV study group. 2022. “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”. Sexually Transmitted Diseases. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/olq.0000000000001620.
clinicaltrials.govStudy
Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study
Dr. Eduardo Franco 2013. "Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01824537.
~86 spots leftby Apr 2025
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