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Immunogenicity and Safety of HPV Vaccine in HIV-infected Pre-adolescent Girls and Boys in Kenya

This study is not yet open for participant recruitment.
Verified October 2011 by Kenyatta National Hospital
Sponsor:
Collaborators:
University of Washington
Merck
Information provided by (Responsible Party):
Nelly R. Mugo, Kenyatta National Hospital
ClinicalTrials.gov Identifier:
NCT01446718
First received: September 30, 2011
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to determine whether the quadrivalent vaccine 'Gardasil' is safe and effective when used by 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.

Human Papillomavirus, also simply called HPV, is known to cause cervical cancer among women and warts in the genital areas for both men and women among other cancers in the throat, anus and penis.

The HPV vaccine has been tested and shown to be effective in preventing infection with HPV types 16, 18, 6 and 11. HPV 16 and 18 cause 70% of cervical cancer and types 6 and 11 cause the majority of anogenital warts.

HIV-infected persons have a higher risk of getting warts and HPV related cancers and would benefit immensely from this vaccine. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.

The investigators therefore propose to enroll 180 girls and boys in Kenya, age 9-14 years and give then the prescribed three doses of vaccine.

The study participants will be closely followed to determine if they suffer any side effects. The investigators shall also measure the response to vaccine at month 7 and 12, these responses will be compared to other data from cohorts of HIV-uninfected persons.

The total follow up time will be 12 months for each child.

Study Location: Partners in Prevention, Thika site


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Quadrivalent HPV Vaccine Among HIV-1 Infected Pre Adolescent Boys and Girls

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Kenyatta National Hospital:

Primary Outcome Measures:
  • immune response to vaccine specific HPV types [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    antibody response to HPV type 6, 11, 16, 18 measured by cLIA


Secondary Outcome Measures:
  • Safety as measured by adverse event reporting [ Time Frame: through out the study ] [ Designated as safety issue: Yes ]
    adverse events attributed to vaccine. Immediate post vaccination adverse events detailed reports will be collected for 1st 14 days post vaccination


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HPV Vaccine
It is a single arm study, comparative group for analysis will use historical cohort data
 Biological: Gardasil vaccine
0.5ml of intramuscular vaccine in three doses
Other Name: Gardasil

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446718

Contacts
Contact: Nelly R Mugo, MbChB, MMed, MPH 2542736744 rwamba@uw.edu
Contact: Kenneth K. Ngure, MPH, PhD Kngure@pipsthika.org

Locations
Kenya
Thika Partners in Prevention Not yet recruiting
Thika, Central Province, Kenya
Principal Investigator: Nelly R. Mugo, MbChB, MPH            
Sub-Investigator: Kenneth K Ngure, MPH            
Sponsors and Collaborators
Nelly R. Mugo
University of Washington
Merck
  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 38406
Study First Received: September 30, 2011
Last Updated: October 4, 2011
Health Authority: Kenya: Pharmacy and Poisons Board

Keywords provided by Kenyatta National Hospital:
quadrivalent vaccine
Human Papillomavirus

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013