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

HIV-1 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446718
• Other study ID #: (MISP)IISP 51802
• Status: Completed
• Start date: December 15, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2019
• Source: Kenya Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Other known NCT identifiers

• NCT01998178

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1 Infection
• Human Papillomavirus

Intervention

Biological:
• Gardasil vaccine
0.5ml of intramuscular vaccine in three doses

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Kenya Medical Research Institute	Merck Sharp & Dohme Corp., University of Washington

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immune response to vaccine specific HPV types	antibody response to HPV type 6, 11, 16, 18 measured by cLIA	48 months
Secondary	immune response to vaccine specific HPV types	HPV infection among sexually active HIV infected adolescents	48 months