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A Single-Arm, Open-Label Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine Among HIV-Positive Women in India

Phase 1
18 Years
Not Enrolling
Cervical Cancer, Nonneoplastic Condition, Precancerous Condition

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Trial Information

A Single-Arm, Open-Label Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine Among HIV-Positive Women in India



- Assess the safety of the Gardasil® quadrivalent human papillomavirus (HPV) (types 6,
11, 16,18) virus-like-particle vaccine with vs without prior exposure to one or more of
the HPV types in the vaccine in HIV-positive women in Chennai, India.

- Determine the effect of the vaccine on HIV viral load and CD4+/CD8+ levels in these

- Determine the proportion of these patients who respond serologically to the HPV vaccine
and the kinetics of their response.


- Determine the prevalence and incidence of cervical intraepithelial neoplasia in these

- Determine the spectrum of cervical HPV types in these patients at baseline, 9 months,
and 1 year after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant
vaccine intramuscularly on day 0 and once in weeks 8 and 24.

Patients undergo cervical cell, buccal cell, and blood sample collection at baseline and
periodically after vaccination for immunologic and virologic studies. Cervical cytology
specimens are examined by polymerase chain reaction to detect HPV 6, 11, 16, or 18 DNA, as
well as 35 other HPV types. Blood samples are analyzed for CD4+/CD8+ cell count, plasma
HIV-1 RNA levels, and serum HPV antibody titers for HPV types 6, 11, 16, and 18. Some plasma
samples will be stored for future HPV pseudovirion neutralization assays.

After completion of study therapy, patients are followed periodically for up to 12 months.

Inclusion Criteria


- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by
western blot before study entry

- HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a
method other than ELISA is acceptable as an alternative confirmatory test

- Meets 1 of the following criteria:

- Nadir CD4 level of ≤ 350 cells/mm³ and receiving highly active antiretroviral
therapy (HAART) for at least 6 months before study entry

- Nadir CD4 level of > 350 cells/mm³ and not receiving HAART at the time of study

- No known history of high-grade CIN or cervical cancer


- Karnofsky performance status 70-100%

- ANC > 750 cells/mm³

- Hemoglobin ≥ 9.0 g/dL

- Platelet count ≥ 100,000/mm³

- Serum creatinine ≤ 3 times upper limit of normal (ULN)

- AST and ALT ≤ 3.0 times ULN

- Conjugated (direct) bilirubin ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active drug or alcohol use or dependence that would interfere with adherence to
study requirements, in the opinion of the site Investigator

- No serious illness requiring systemic treatment and/or hospitalization within the
past 45 days

- No allergy to yeast or any of the components of quadrivalent human papillomavirus
(types 6, 11, 16, 18) recombinant vaccine


- See Disease Characteristics

- More than 45 days since prior systemic antineoplastic or immunomodulatory treatment,
systemic corticosteroids, investigational vaccines, interleukins, interferons, growth
factors, or intravenous immunoglobulin

- Routine standard of care, including hepatitis B, influenza, and tetanus vaccines
are allowed

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Safety, in terms of grade 3 or 4 adverse events attributed to the vaccine, according to NCI CTCAE v3.0

Outcome Time Frame:

52 weeks from study entry

Safety Issue:


Principal Investigator

Joel Palefsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

August 2009

Completion Date:

November 2012

Related Keywords:

  • Cervical Cancer
  • Nonneoplastic Condition
  • Precancerous Condition
  • human papilloma virus infection
  • cervical cancer
  • cervical intraepithelial neoplasia
  • HIV infection
  • Uterine Cervical Neoplasms
  • HIV Seropositivity
  • Precancerous Conditions