Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents

NCT05435209 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00013326
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection. 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.

Conditions

HPV Infection; HPV Vaccination

Keywords

Genital HPV infection; quadrivalent HPV vaccination; HIV-infected; adolescents

Outcome Measures

Primary Outcomes (2)

• Persistent Genital HPV infection

  Number of participants with incident persistent genital infection with the QHPV specific serotypes: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes (31,33,35,39,45,51,52,56,58,59,66, 68,73)

  Nine years after primary vaccination

• Sustained QHPV vaccine specific antibody titers

  Concentration of QHPV specific antibody titers (HPV -6, -11, -16 \& -18) nine years after primary vaccination

  Nine years after primary vaccination

Secondary Outcomes (1)

• Immune memory following three doses of QHPV

  One month after booster vaccine

Study Arms (1)

Quadrivalent HPV Vaccine

EXPERIMENTAL

Gardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh

Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Interventions

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine DRUG

Gardasil

Also known as: Gardasil-4

Quadrivalent HPV Vaccine

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV-infected
• enrolled previously and received received three doses of quadrivalent HPV- vaccine in 2014

You may not qualify if:

• Decline re-enrollment
• unable to provide informed consent
• minor without parent or guardian consent

Sponsors & Collaborators

• University of Washington: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Phrd-Ccr-Kemri

Thika, Kiambu County, Kenya

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Vaccines, Synthetic

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Study Officials

• Nelly Mugo, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Global Health

Model Details: Quadrivalent HPV vaccine

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 28, 2022
• Study Start: May 25, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

KE (1)