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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Washington
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Nelly R. Mugo, Kenyatta National Hospital
ClinicalTrials.gov Identifier:
NCT01446718
First received: September 30, 2011
Last updated: November 25, 2013
Last verified: November 2013

September 30, 2011
November 25, 2013
May 2013
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01446718 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of HPV Vaccine in HIV-infected Pre-adolescent Girls and Boys in Kenya
Immunogenicity and Safety of Quadrivalent HPV Vaccine Among HIV-1 Infected Pre Adolescent Boys and Girls

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Human Papillomavirus
  • HIV-1 Infection
Biological: Gardasil vaccine
0.5ml of intramuscular vaccine in three doses
Other Name: Gardasil
HPV Vaccine
It is a single arm study, comparative group for analysis will use historical cohort data
Intervention: Biological: Gardasil vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
9 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01446718
(MISP)IISP 38406
No
Nelly R. Mugo, Kenyatta National Hospital
Nelly R. Mugo
  • University of Washington
  • Merck Sharp & Dohme Corp.
Not Provided
Kenyatta National Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP