Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents
NCT ID: NCT05435209
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
158 participants
INTERVENTIONAL
2022-05-25
2023-10-31
Brief Summary
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Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection.
Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.
Detailed Description
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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 231 doses for the HIV-infected adolescent.
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.
Among those that have not become sexually active, or that decline a genital exam, a self-collected swab will be requested. A sub-set of approximately 30 participants, will receive a booster dose of QHPV, from this subset, Peripheral Blood Mononuclear Cells (PBMC) and plasma samples will be collected at enrollment, at month 1 and month 12 to evaluate for memory B and T cell responses.
The total duration of study follow up will be 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Quadrivalent HPV Vaccine
Gardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Gardasil
Interventions
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Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Gardasil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* enrolled previously and received received three doses of quadrivalent HPV- vaccine in 2014
Exclusion Criteria
* unable to provide informed consent
* minor without parent or guardian consent
16 Years
25 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University of Washington
OTHER
Responsible Party
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Nelly Mugo
Associate Professor, School of Medicine: Global Health
Principal Investigators
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Nelly Mugo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Phrd-Ccr-Kemri
Thika, Kiambu County, Kenya
Countries
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Other Identifiers
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STUDY00013326
Identifier Type: -
Identifier Source: org_study_id