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Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda


N/A
12 Years
20 Years
Open (Enrolling)
Female
HPV6 and HPV18, Immunogenicity, HPV Vaccine, Cervical Cancer, Partial Vaccination

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Trial Information

Immunogenicity of Bivalent HPV Vaccine Among Partially Vaccinated Young Adolescent Girls in Uganda


Background:

Recent experience with HPV vaccine implementation in low resource settings has suggested
that high vaccine coverage for all three doses could be achieved provided programs are
planned well and have full and complementary components in place. However, some locations
experienced substantial rates of partially vaccinated girls, those who received only one or
two doses. From the vaccine trial data published thus far, we know that the vaccines produce
high levels of type-specific anti-HPV antibodies which begin to stabilize past 24 months
post-vaccination. Without an immune correlate of protection, it is difficult to know whether
girls who received one or two vaccine doses will still experience the same benefit of
protection from HPV infection as those who received all three doses of vaccine.

Recent data from a trial of a two-dose regimen of vaccination of girls aged 9-13 years in
Vancouver, Canada have suggested that the immune response of girls who received only two
doses was non-inferior both to that of girls who received 3 doses and to that of adult women
aged 16-25 years who also received 3 doses. In a complementary study in Guanacaste, Costa
Rica, vaccine efficacy (defined as 12-month vaccine type-specific infection persistence)
among adult women who received either one or two doses of HPV vaccine as a part of the Phase
IIb clinical trials of Cervarix (GSK) was similar to women who received all three vaccines
doses.

This proposed study would provide additional insight into the immunogenicity of HPV vaccine
among partially vaccinated girls in Uganda, which could add supportive evidence in an
African adolescent population (currently not represented in any clinical studies of HPV
vaccines) of the immunological implications of receiving less than 3 doses of HPV vaccine.

Objective:

To investigate whether the anti-HPV 16 and/or anti-HPV-18 immune responses elicited by the
bivalent vaccine for girls who received one dose and those who received two doses are
similar at greater than or equal to 24 months (after last dose) to girls who received all
three doses of bivalent HPV vaccine.

Eligibility:

Girls who received at least one dose of the HPV vaccine, 12-20 years of old, in apparent
good general health.

Design:

This is a cross-sectional immunogenicity study with three groups:

Group 1 - 200 girls who received only one dose of HPV vaccine as a part of the PATH-UNEPI
HPV vaccine demonstration project;

Group 2 - 200 girls who received only two doses of HPV vaccine as a part of the PATH-UNEPI

HPV vaccine demonstration project; and

Group 3 - 200 girls who received all three doses of HPV vaccine as a part of the PATH-UNEPI
HPV vaccine demonstration project.

This study will enroll girls (by group) within one district of Uganda from an HPV vaccine
registry maintained by the district.

Antibody level will be parameterized as the geometric mean titre of serum antibody to HPV
types 16 and/or 18 at greater than or equal to 24 months after last dose of vaccine. Titres
will be measured using the polyclonal Direct VLP ELISA.

Inclusion 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(Trademark) (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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Mahboobeh Safaeian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999912021

NCT ID:

NCT01520272

Start Date:

January 2012

Completion Date:

Related Keywords:

  • HPV6 and HPV18
  • Immunogenicity
  • HPV Vaccine
  • Cervical Cancer
  • Partial Vaccination
  • HPV16 and HPV18 Immunogenicity
  • Bivalent HPV16/18 Vaccine
  • Less than 3 Dosed of the Bivalent HPV Vaccine
  • HP Vaccine
  • Uterine Cervical Neoplasms

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