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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Washington
Merck Sharp & Dohme Corp.
Kenya Medical Research Institute
Information provided by (Responsible Party):
Nelly R. Mugo, Kenyatta National Hospital
ClinicalTrials.gov Identifier:
NCT01446718
First received: September 30, 2011
Last updated: March 20, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus
HIV-1 Infection
Biological: Gardasil vaccine
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Kenyatta National Hospital:

Primary Outcome Measures:
  • immune response to vaccine specific HPV types [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    antibody response to HPV type 6, 11, 16, 18 measured by cLIA


Secondary Outcome Measures:
  • immune response to vaccine specific HPV types [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    HPV infection among sexually active HIV infected adolescents


Biospecimen Retention:   None Retained

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


Enrollment: 179
Study Start Date: December 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Gardasil

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

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446718

Sponsors and Collaborators
Kenyatta National Hospital
University of Washington
Merck Sharp & Dohme Corp.
Kenya Medical Research Institute
Investigators
Principal Investigator: Nelly R Mugo, MMed, MPH Kenya Medical Research Institute (KEMRI)
  More Information

No publications provided

Responsible Party: Nelly R. Mugo, Dr., Kenyatta National Hospital
ClinicalTrials.gov Identifier: NCT01446718     History of Changes
Other Study ID Numbers: (MISP)IISP 51802
Study First Received: September 30, 2011
Last Updated: March 20, 2015
Health Authority: Kenya: Pharmacy and Poisons Board

Keywords provided by Kenyatta National Hospital:
quadrivalent vaccine
Human Papillomavirus

ClinicalTrials.gov processed this record on July 27, 2015