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

NCT ID: NCT01446718

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 179 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-15
• Study Completion Date: 2018-06-30

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.

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

Conditions

Human Papillomavirus; HIV-1 Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Gardasil vaccine

Intervention Type: BIOLOGICAL

0.5ml of intramuscular vaccine in three doses

Interventions

Gardasil vaccine

0.5ml of intramuscular vaccine in three doses

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Nelly Rwamba Mugo

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nelly R Mugo, MMed, MPH

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Other Identifiers

(MISP)IISP 51802

Identifier Type: -

Identifier Source: org_study_id

NCT01998178

Identifier Type: -

Identifier Source: nct_alias