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Randomized Controlled Trial
. 2022 Jun 1;49(6):414-422.
doi: 10.1097/OLQ.0000000000001620. Epub 2022 Mar 2.

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

Aaron MacCosham  1 , Mariam El-Zein  1 , Ann N Burchell, Pierre-Paul Tellier  2 , François Coutlée  3 , Eduardo L Franco  1 ; TRAP-HPV study group
Affiliations
Randomized Controlled Trial

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

Aaron MacCosham et al. Sex Transm Dis. .

Abstract

Background: It is unknown whether recently human papillomavirus (HPV)-vaccinated individuals confer protection against vaccine-preventable HPV types to their partners.

Methods: Participants 18 to 45 years old who were living in Montreal, Canada, and in a heterosexual relationship of 6 months or less were randomly assigned to receive the intervention HPV vaccine, Gardasil or Gardasil 9, or active control (AC), Avaxim, a hepatitis A vaccine. Couples attended a maximum of 6 clinic visits (baseline and at 2, 4, 6, 9, and 12 months) and provided genital samples for detection of 36 HPV genotypes. Participants were vaccinated at baseline and at 2 and 6 months. We used Cox proportional hazards regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between the administered vaccine and infections at the HPV episode level.

Results: We restricted analyses to 273 participants (intervention: n = 141, AC: n = 132) who had at least 2 visits with valid HPV data. The HR of becoming positive for a given vaccine-preventable HPV type in the intervention group among those who received at least 1 dose compared with AC was 0.47 (95% CI, 0.23-0.97). Comparing individuals with HPV-vaccinated versus AC-vaccinated partners, there was no difference in risk of becoming positive for a given vaccine-preventable HPV type among those whose partners received at least 1 (HR, 1.46; 95% CI, 0.73-2.94) or 2 (HR, 0.78; 95% CI, 0.31-1.96) doses.

Conclusions: Our study provides inconclusive evidence that individuals whose partner recently received an HPV vaccine are protected from vaccine-preventable types but demonstrates that vaccinated individuals are at a lower risk of incident infections.Trial Registration Number: NCT01824537.

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Conflict of interest statement

Conflict of Interest and Sources of Funding: E.L.F. reports grants and personal fees from Merck; grants, personal fees, and nonfinancial support from Roche; and personal fees from GSK, all outside the submitted work. M.E.-Z. and E.L.F hold a patent related to the discovery “DNA methylation markers for early detection of cervical cancer,” registered at the Office of Innovation and Partnerships, McGill University, Montreal, Quebec, Canada (October, 2018). A provisional utility patent application before the US Patent & Trademark Office was also filed (November 2018), and a Patent Cooperation Treaty application (PCT/IB2020/050885), filed in February 2020, has been published under No. WO 2020/115728 (June 2020). A.M. reports a fellowship from the Canadian Institutes of Health Research and McGill Faculty of Medicine Internal Studentship Award (jointly funded by Gershman Memorial Fellowship and the Dr John A. Lundie Research Fellowship), outside the submitted work. F.C. has received grants or free reagents through his institution from Merck Sharp and Dome, Becton Dickinson, and Roche, as well as honoraria from Merck and Roche for lectures on HPV. A.N.B. and P.-P.T. have no conflicts of interest to disclose.

References

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    1. Simelela PN. WHO global strategy to eliminate cervical cancer as a public health problem: An opportunity to make it a disease of the past. Int J Gynecol Obstet 2021; 152:1–3.
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