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

A Longitudinal Observational Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 9-14 Years in Kenya

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.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection; Human Papillomavirus
• Intervention / Treatment: Biological: Gardasil vaccine

Detailed Description

HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have a 2-22 fold increased risk for cervical cancer compared to uninfected women. The quadrivalent HPV vaccine marketed as "Gardasil" has demonstrated efficacy against type specific HPV infections known to cause 70% cervical cancer (HPV 16 & 18) and HPV 6 & 11 known to cause 90% of anogenital warts in populations of HIV negative young women.

Since the risk of HPV exposure persists throughout a person's sexual life, the duration of protection, especially when the vaccine is given in the pre-adolescent period, is critical to overall vaccine effectiveness. Extended follow up of HIV-uninfected individuals has shown sustained response to HPV vaccine for 8.4 and 6 years respectively to the bivalent and quadrivalent vaccines. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.

Data on immunogenicity of the HPV vaccine among HIV infected adolescents is limited to a 12 month follow up period.

Current HPV vaccine guidelines target pre-sexual adolescents. Since the risk of HPV exposure persists throughout an individual's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. Duration of sustained HPV 6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the need for booster dosing.

The investigators therefore propose to extend follow up of 179 girls and boys in Kenya, age 9-14 years who have received 3 doses of the quadrivalent 'Gardasil' vaccine and assess for immunogenicity annually.

Study Location: Partners in Prevention, Thika site

• Study Type: Observational
• Enrollment (Actual): 179

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 0.5ml of intramuscular vaccine in three doses; Other Names: Gardasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune response to vaccine specific HPV types	antibody response to HPV type 6, 11, 16, 18 measured by cLIA	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune response to vaccine specific HPV types	HPV infection among sexually active HIV infected adolescents	48 months

Collaborators and Investigators

• Sponsor: Kenya Medical Research Institute
• Collaborators: Merck Sharp & Dohme LLC; University of Washington
• Investigators: Principal Investigator: Nelly R Mugo, MMed, MPH, Kenya Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2014
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Human Papillomavirus; quadrivalent vaccine
• Other Study ID Numbers: (MISP)IISP 51802