A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years

NCT01446718 | Completed

• 1 other identifier: (MISP)IISP 51802
• Study Type: observational
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine.

Conditions

Human Papillomavirus; HIV-1 Infection

Keywords

quadrivalent vaccine; Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• immune response to vaccine specific HPV types

  antibody response to HPV type 6, 11, 16, 18 measured by cLIA

  48 months

Secondary Outcomes (1)

• immune response to vaccine specific HPV types

  48 months

Study Arms (1)

Gardasil Vaccine

This is an extension of follow up for participants who received 3 doses of Gardasil vaccine in the "Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-Infected Pre-Adolescent Girls and Boys in Kenya" study.

Biological: Gardasil vaccine

Interventions

Gardasil vaccine BIOLOGICAL

0.5ml of intramuscular vaccine in three doses

Also known as: Gardasil

Gardasil Vaccine

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be enrolled from the paediatric HIV-care clinic

You may qualify if:

• HIV-infected
• age 9-14 years
• guardian/parental consent

You may not qualify if:

• Participants will be excluded if they
• are severely ill as defined by Karnofsky \<70
• have a diagnosis of malignancy
• on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection
• have received systemic corticosteroids within prior one year
• have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks
• have history of allergy to any products included in the HPV vaccine
• have received any of blood derivatives within prior 6 months
• are pregnant
• lack parental consent and/or parent declines to provide assent

Sponsors & Collaborators

• Kenya Medical Research Institute: lead
• University of Washington: collaborator
• Merck Sharp & Dohme LLC: collaborator

Biospecimen

Retention: NONE RETAINED

Plasma for HPV antibody testing there will be no long term sample storage

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Nelly R Mugo, MMed, MPH

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 5, 2011
• Study Start: December 15, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07