Immune Response and Safety Study of Human Papillomavirus (HPV) Vaccine in HIV-infected Pre-adolescent 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:
NCT01998178
First received: September 9, 2011
Last updated: November 25, 2013
Last verified: November 2013

September 9, 2011
November 25, 2013
May 2013
August 2015   (final data collection date for primary outcome measure)
Antibody titre to HPV virus like particles as determined by the quadrivalent HPV competitive Luminex immunoassay (cLIA) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
The purpose of the cLIA is to detect antibody to HPV virus like particles before and after vaccination and is specific to HPV types.
Same as current
Complete list of historical versions of study NCT01998178 on ClinicalTrials.gov Archive Site
  • To correlate the immune response, as measured by antibody titers, with the degree of immunosuppression. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Most of the HIV-Infected boys and girls will be on HAART and thus have achieved partial immune reconstitution. However, nadir pre-HAART CD4 and WHO HIV disease stage as indicators of past immunosuppression, enrollment plasma HIV levels as an indicator of viral control on HAART, and enrollment CD4 compared to nadir CD4 as an indicator of immune reconstitution, may correlate with HPV vaccine immune response as measured by HPV antibody titers at months 7 and 12 post vaccination.
  • To assess the safety and tolerability of the quadrivalent HPV vaccine (Gardasil) in boys and girls age 9-14 years in Kenya. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

    The vaccine report card will be utilized to record immediate post vaccine events for a period of 14 days after each vaccine dose.

    Adverse events reports will be gathered through out the study period and categorized as Severe adverse Events (SAEs) and Adverse Events (SAEs).

    All SAEs will be reported to the regulatory authorities within a stipulated time limit

Same as current
Not Provided
Not Provided
 
Immune Response and Safety Study of Human Papillomavirus (HPV) Vaccine in HIV-infected Pre-adolescent in Kenya
Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-infected Pre-adolescent Girls and Boys in Kenya

The purpose of this study is to determine if the quadrivalent HPV vaccine 'Gardasil' is effective in eliciting a protective immune response among HIV-1 infected adolescents girls and boys age 9-14 years comparable to historical cohorts of HIV-1 uninfected women. The study will also determine if this response, differs by the degree of immunosuppression.

The study will also determine the safety and tolerability of the 'Gardasil' vaccine among HIV-1 infected boys and girls age 9-14.

Human Papillomavirus (HPV) is a common sexually transmitted infection, with more than 50% of young women infected within few years of initiatiing sexual activity. Persistent infection with high risk HPV types is known to cause cervical cancer among other tumors and genital warts. Cervical cancer and its precancerous lesions, genital warts are more common among HIV-1 infected individuals, among whom, cancer occurs at an earlier age and progresses more quickly.

The HPV 'Gardasil'vaccine has been tested widely among HIV-1 negative persons demonstrating high efficacy and safety profiles, it is widely registered for use across continents. However, there is minimal data in HIV-1 infected persons.

For many immunizations, HIV-1 infected persons experience lower immune responses compared to HIV-uninfected persons.

The investigators therefore propose to conduct a prospective study of the quadrivalent HPV 'Gardasil' vaccine among pre adolescent HIV infected girls and boys age 9-14 years in Kenya to extend current understanding f safety and immunogenicity.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Genital Warts
  • Cervical Cancer
Biological: Quadrivalent HPV Vaccine
Intramuscular injections of 0.5 mls 'Gardasil' at enrollment, month 2 and month 6 visits the study has one study arm and the comparative data will be from historical cohorts
Other Name: Gardasil
Experimental: Gardasil, Quadrivalent HPV Vaccine

Injection of 0.5mls HPV Gardasil Quadrivalent Vaccine administered at enrollment, month 2 and month 6.

Gardasil, is a Quadrivalent HPV Vaccine which has been tested to have high efficacy against HPV 6,11,16 and 18.

Intervention: Biological: Quadrivalent HPV 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 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. laboratory confirmed HIV-1 infection,
  2. age range 9-14 years, and
  3. parental or guardian consent and participant assent

Exclusion Criteria:

  1. are severely ill, as defined by Karnofsky score <70,
  2. have a diagnosis of malignancy,
  3. on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection,
  4. have received systemic corticosteroids within prior one year,
  5. have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks,
  6. have history of allergy to any products included in the HPV vaccine,
  7. have received any of blood derivatives within prior 6 months,
  8. are pregnant
  9. lack parental consent and/or child declines to provide assent.
Both
9 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01998178
HPV IISP 38406
No
Nelly R. Mugo, Kenyatta National Hospital
Kenyatta National Hospital
  • University of Washington
  • Merck Sharp & Dohme Corp.
Principal Investigator: Nelly R. Mugo, MbCHB, MPH Kenyatta National Hospital
Kenyatta National Hospital
November 2013

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