Effectiveness and B-memory Cell Response to QHPV Vaccine 9-years Post-vaccination Among HIV-infected Boys and Girls

June 3, 2021 updated by: Nelly Rwamba Mugo, Kenya Medical Research Institute

Effectiveness of the QHPV Among Kenyan HIV Infected Girls and Boys 9 Years Post Vaccination

In 2013, the Investigators enrolled a cohort of 180 HIV-1 infected adolescent girls and boys ages 9-14 years and administered three doses of the QHPV vaccine (NCT04711265). For this study, the Investigators shall evaluate vaccine effectiveness 9 years post first vaccination.

Participants will be evaluated for HPV type specific antibody, genital HPV infection, genital warts and a subset of 30 participants will be evaluated for memory B and T cell responses.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Genital Human Papilloma Virus (HPV) infections occur rapidly after sexual debut, and immunosuppressed individuals are at greater risk for incident and persistent infection. HPV vaccine contains virus-like participles (VLP), which are highly immunogenic and induce a robust humoral response that has been demonstrated to confer long term protection from HPV infection and associated disease among HIV-uninfected individuals.

The magnitude of type-specific vaccine induced neutralizing HPV antibody responses are diminished among HIV-infected compared to uninfected individuals.

There is no established minimum level of antibody that predicts protection against HPV infection or associated disease, the impact of lower antibody titers among HIV infected individuals on vaccine efficacy is unknown. The risk of HPV exposure persists throughout a person's sexual life and the duration of protection, especially when the vaccine is given in the early adolescent period is critical to vaccine effectiveness. Long lasting memory is characterized by memory B cells and long-lived plasma cells and a QHPV booster dose has demonstrated an anamnestic response among HIV-infected adolescents.

HPV efficacy and effectiveness data for HIV-uninfected individuals has informed the current World Health Organization (WHO) two-dose vaccine schedule. The field lacks data on effectiveness of three dose or two-dose for the HIV-infected adolescents. The current on-going research for single dose schedules gives urgency to the determination of long-term efficacy of three HPV vaccine doses for the HIV-infected adolescent.

The Investigators shall recall HIV-infected girls and boys who were previously vaccinated at ages 9-14 years with three doses of the quadrivalent vaccine (QHPV) in 2014 and evaluated for vaccine immunogenicity.

Method: The participants will be assessed for genital warts and genital HPV infection. Type specific HPV DNA will be assessed using genital swabs and genital warts assessed through physical examination among sexually active participants at enrollment, month 6 &12.

A sub-set of study participants will receive a booster dose of QHPV and evaluated for memory B and T cell responses.

The total duration of study follow up will be 12 months

Study Type

Observational

Enrollment (Anticipated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nelly Mugo, MD
  • Phone Number: 254733629665
  • Email: rwamba@uw.edu

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study aims to enroll 135 HIV-1 infected boys and girls, who previously received three doses of quadrivalent HPV vaccine in the safety and immunogenicity study (MISP 38406)

Description

Inclusion Criteria:

  1. received three doses of the quadrivalent HPV vaccine and enrolled in the quadrivalent HPV vaccine safety and immunogenicity study (MISP 38406)
  2. participant consent or parental/guardian consent and participant assent for participants still <18 years of age
  3. participants and guardians who consented to be contacted for further evaluation and participation in research and
  4. are willing to continue longer-term follow up.

Exclusion Criteria:

  1. Did not participate in the quadrivalent HPV vaccine safety and immunogenicity study (MISP 38406)
  2. Not willing or able to provide written informed consent/assent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
QHPV Vaccine
all participants have received QHPV
Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine
No intervention will be administered
Other Names:
  • Gardasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in persistent Genital HPV infection
Time Frame: The changes will be measured at baseline (enrolment), month 6 and 12
Type specific HPV serotype: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes 31,33,35,39,45,51,52,56,58,59,66, 68,73 as per International Agency for Research on Cancer (IARC) monographs.
The changes will be measured at baseline (enrolment), month 6 and 12
Changes in geometric titers for HPV-specific Antibodies
Time Frame: This outcome will be measured at Month 12
Vaccine type specific HPV antibody Geometric Mean Titers: HPV- 6, 11, 16 & 18
This outcome will be measured at Month 12
B-memory cell elicitation in the participants given a booster vaccine
Time Frame: This will be measured at 12 months after receiving a booster vaccine
Elicited from Peripheral Blood Mononuclear Cell (PBMC)
This will be measured at 12 months after receiving a booster vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenya Medical Research Institute

Collaborators

University of Washington

Investigators

  • Principal Investigator: Nelly R. Mugo, MMed Obs Gyn, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • MISP 60583

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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