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HPV Vaccine Effectiveness in Partially Vaccinated Girls in Uganda

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01520272
First received: January 26, 2012
Last updated: November 11, 2014
Last verified: September 2014
  Purpose

Background:

- Cervical cancer is one of the leading causes of cancer death in women worldwide and in Uganda. It is caused by the human papillomavirus (HPV). A vaccine against HPV was offered for all 10-year-old girls in the Nakasongola district of Uganda from October 1, 2008, to October 31, 2009. The HPV vaccine requires three doses; however, some girls received only one or two doses. Researchers want to compare vaccine immunogenicity in girls who received all three doses with those who had only one or two doses.

Objectives:

- To examine the immunogenicity (antibody levels) of girls in Uganda who received only one, two or three doses of HPV vaccine.

Eligibility:

  • Girls who will be at least 12 years old by October 31, 2011, and had at least one dose of the HPV vaccine.
  • All participants will come from the Nakasongola district of Uganda.

Design:

  • Participants will have a physical exam and answer questions about their medical history and HPV risk.
  • Participants will provide a single blood sample for testing.
  • Treatment and vaccines will not be provided as part of this study. Girls who did not receive all three doses of the HPV vaccine will be given information about the nearest health center. Health centers will provide the missed doses free of charge.

Condition
HPV16 Anitbody Levels Post Vaccination
HPV18 Antibody Levels Post Vaccination

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • HPV Immunogenicity [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2012
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

The following inclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit, immediately prior to blood draw:

  • Subject is aged 12-17 years as of August 31, 2011.
  • Subject received at least one dose of HPV vaccine, Cervarix (GSK, UK), from October 1, 2008 through October 31, 2009 as a part of the PATH HPV vaccine demonstration project in Nakasongola, Uganda.
  • Signed and dated informed written consent form (with both parent and subject s signatures) received (confirmed at clinic visit).
  • Subject is afebrile, in good apparent health (confirmed at clinic visit).
  • Subject assents to participate (confirmed at clinic visit).
  • Subject is able to comply with the study protocol (confirmed at clinic visit).
  • Subject plans to stay in Nakasongola for the duration of enrolment, which is expected to be about week between signed consent and blood draw.

EXCLUSION CRITERIA:

The following exclusion criteria will be reviewed at the time of enrollment, and where noted, confirmed at the clinic visit.

  • Prior HPV vaccination outside the PATH HPV vaccine demonstration project period.
  • Subject is known to be pregnant or lactating at the time of the scheduled blood draw (confirmed at clinic visit).
  • Subject has an apparent moderate or severe acute illness or has fever (confirmed at clinic visit).
  • Clinical history of bleeding disorders such as haemophilia, thrombocytopenia, or anticoagulant therapy.
  • Investigational drug or investigational vaccine or licensed vaccine administered during the period from 30 days before the date of the scheduled blood draw (confirmed at clinic visit).
  • Subject receives immunoglobulins and/or any blood products during the period from 30 days before the date of the scheduled blood draw (confirmed at clinic visit).
  • Subject or subject s parents refused to sign written consent.
  • Subject does not assent at the time of the blood draw.
  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: NCT01520272

Locations
Uganda
District of Nakasangola
Kampala, Uganda
Sponsors and Collaborators
Investigators
Principal Investigator: Mahboobeh Safaeian, M.D. National Cancer Institute (NCI)
  More Information