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HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV

NCT05247853CompletedOBSERVATIONAL

Summary

Our study will assess and measure population effectiveness of prophylactic HPV vaccine in reducing cervical, anal, and/or oral prevalent and 6-month persistent infections among HPV-vaccinated and 757 HPV-unvaccinated Rwandan WLWH aged 18-26 years. Additional objectives include the quantification \& examination of long-term antibody (into young adulthood) responses to HPV vaccination and to validate the performance (e.g., sensitivity and specificity) of a low-cost, POC (point-of-care) anti-HPV16 antibody test to determine/confirm HPV vaccination status. The findings for this study will provide necessary evidence regarding the long-term protection afforded by HPV vaccination in WLWH living in SSA, who are at the greatest risk of HPV-related cancers.

Key Facts

Lead Sponsor

Montefiore Medical Center

Enrollment

3127

Start Date

2021-11-03

Completion Date

2024-12-12

Study Type

OBSERVATIONAL

Official Title

Long-Term Human Papillomavirus Vaccination Effectiveness and Immunity in Rwandan Women Living With and Without Human Immunodeficiency Virus

Interventions

Blood collectionOralcervicovaginal and anal specimen collectionAnoscopy & Biopsy of Acetowhite LesionsColposcopy & Biopsy of Acetowhite LesionsAblative TreatmentLEEP (Loop Electrosurgical Excision Procedure)

Conditions

Cervical CancerHuman Papilloma VirusHuman Immunodeficiency VirusHPV-Related Carcinoma

Eligibility

Age Range

18 Years – 28 Years

Sex

FEMALE

Inclusion Criteria:

* Female
* 18-28 years. The age of inclusion criteria will likely be restricted as age-specific enrollment goals are met.
* Physically and mentally able and willing to participate in the study.
* Willing to provide written and signed or thumb printed, informed consent.
* Known to be living with HIV (i.e., enrolled in a treatment program), or consent to HIV testing to confirm HIV status.

Exclusion Criteria:

* Have positive pregnancy test or report to be pregnant at the time of visit or less than 6 weeks post-partum (will be asked to make an appointment 6 or more weeks post-partum)
* Report to be menstruating at the time of visit (will be asked to make new appointment)
* History of hysterectomy and no longer have a cervix
* History of treatment for cervical abnormalities after cervical screening
* History of cervical cancer
* Report no previous sexual activity
* HIV status is unknown, and date of birth is 12/31/1995 or earlier
* Because this study has age-specific enrollment goals for WLWH and HIV\[-\] women, once those enrollment goals are met for each study group, the respective cohorts will be closed and other eligible women will be excluded.

Outcome Measures

Primary Outcomes

Change in vaccine effectiveness of prophylactic HPV vaccine

To measure population effectiveness of prophylactic HPV vaccine in reducing cervicovaginal, anal, and/or oral prevalent and 6-12 month persistent infections by HPV6/11/16/18

Time frame: Baseline and up to 12 months

Change in long-term antibody responses to HPV vaccination

To quantify, and examine the determinants of, long-term antibody (into young adulthood) responses to HPV vaccination

Time frame: Baseline and up to 12 months

Locations

Rwanda Military Hospital, Kigali, Rwanda

Linked Papers

2023-05-16

Impact of the human papillomavirus vaccine in low-resource settings

2022-08-25

Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol

Introduction Prophylactic human papillomavirus (HPV) vaccines have been shown to be highly effective in protecting women against cervical infections, high-grade abnormalities and cancer caused by the targeted HPV types. However, the evidence for their effectiveness in women living with HIV (WLWH) is less clear. Methods WLWH and HIV-negative women who likely did (birth cohorts 1996 and later) and WLWH and HIV(−) negative who likely did not (birth cohorts before 1996) receive HPV vaccination (n=3028; 757 participants for each of the four groups). Between groups, we will compare cervicovaginal, anal and oral prevalent and 6–12 month persistent HPV6/11/16/18 infections as measured using a modified AmpFire HPV genotyping assay that tests for 15 high-risk or intermediate-risk HPV genotypes, HPV6 and HPV11. We will also compare the HPV immune response in HPV-vaccinated WLWH to HPV-vaccinated HIV-negative women using an anti-HPV16 and anti-HPV18 ELISA. Vaccination status will be confirmed through national vaccination records. Analysis We will calculate point prevalence and prevalence of 6–12 month persisting infections by individual HPV-type specific infections and groups of infections for each anatomic site and for each group of women. Results will be stratified by age at vaccination, age at enrolment and the number of doses (3 vs 2) as well as other factors possibly associated with HPV prevalence. Differences in endpoints between groups, overall and between subgroups, will be tested for statistical significance (p<0.05) using Fisher’s exact or Pearson χ2 test. Differences in geometric mean titres and seropositivity will be tested for statistical significance using the Mann-Whitney and Fisher’s exact tests, respectively. Ethics and dissemination The study was approved by the Albert Einstein College of Medicine Institutional Review Board and the Rwanda National Ethics Committee. Results will be disseminated through publication in peer-reviewed journals.

Linked Investigators

Gad Murenzi

Kathryn Anastos

Philip E Castle