Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
University of Washington
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nelly R. Mugo, Kenyatta National Hospital Identifier:
First received: September 30, 2011
Last updated: February 2, 2015
Last verified: February 2015

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.

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

Study Type: Interventional
Study Design: 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 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: 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

Enrollment: 180
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: November 2014 (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 Gardasil Vaccine: three 0.5 mL intramuscular injections of 40/80/80/40 mcg/mL of suspended virus-like particles of human papillomavirus type 6,11,16 and 18. The second and third administered 1 and 6 months after the first.
Biological: Gardasil vaccine
0.5ml of intramuscular vaccine in three doses
Other Name: Gardasil

Detailed Description:

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


Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01446718

Thika Partners in Prevention
Thika, Central Province, Kenya
Sponsors and Collaborators
Nelly R. Mugo
University of Washington
Merck Sharp & Dohme Corp.
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 Identifier: NCT01446718     History of Changes
Other Study ID Numbers: (MISP)IISP 38406
Study First Received: September 30, 2011
Last Updated: February 2, 2015
Health Authority: Kenya: Pharmacy and Poisons Board

Keywords provided by Kenyatta National Hospital:
quadrivalent vaccine
Human Papillomavirus processed this record on March 01, 2015