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
  Purpose

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.


Condition Intervention Phase
Genital Warts
Cervical Cancer
Biological: Quadrivalent HPV Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-infected Pre-adolescent Girls and Boys in Kenya

Resource links provided by NLM:


Further study details as provided by Kenyatta National Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 180
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01998178

Locations
Kenya
Partners in Prevention
Thika, Kiambu, Kenya
Sponsors and Collaborators
Kenyatta National Hospital
University of Washington
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Nelly R. Mugo, MbCHB, MPH Kenyatta National Hospital
  More Information

No publications provided

Responsible Party: Nelly R. Mugo, Principal Investigator, Kenyatta National Hospital
ClinicalTrials.gov Identifier: NCT01998178     History of Changes
Other Study ID Numbers: HPV IISP 38406
Study First Received: September 9, 2011
Last Updated: November 25, 2013
Health Authority: Kenya: Pharmacy and Poisons Board

Keywords provided by Kenyatta National Hospital:
HPV
Cervical Cancer
HIV-1

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014