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Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

Primary Purpose

Cervical Cancer, Nonneoplastic Condition, Precancerous Condition

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
DNA analysis
polymerase chain reaction
cytology specimen collection procedure
colposcopic biopsy
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring human papilloma virus infection, cervical cancer, cervical intraepithelial neoplasia, HIV infection

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Sites / Locations

  • YRG Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gardasil Vaccination

Arm Description

Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.

Outcomes

Primary Outcome Measures

Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Number of Patients With a Significant Increase in HIV Viral Load
Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions
Number of Patients With Detectable Antibodies to HPV-6
Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Number of Patients With Detectable Antibodies to HPV-11
Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Number of Patients With Detectable Antibodies to HPV-18
Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline

Secondary Outcome Measures

Full Information

First Posted
April 25, 2008
Last Updated
February 1, 2016
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00667563
Brief Title
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer. PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well it works in preventing cervical cancer in women in India with HIV-1 infection.
Detailed Description
OBJECTIVES: Primary 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 patients. Determine the proportion of these patients who respond serologically to the HPV vaccine and the kinetics of their response. Secondary Determine the prevalence and incidence of cervical intraepithelial neoplasia in these patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Nonneoplastic Condition, Precancerous Condition
Keywords
human papilloma virus infection, cervical cancer, cervical intraepithelial neoplasia, HIV infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gardasil Vaccination
Arm Type
Experimental
Arm Description
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
Intervention Type
Biological
Intervention Name(s)
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Intervention Description
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Other Intervention Name(s)
HIV viral load test and HPV neutralization assays.
Intervention Description
Weeks 0, 2, 10, 26, and 52.
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Description
Screening, week 36, and week 52.
Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Intervention Description
Screening, week 36, and week 52.
Intervention Type
Procedure
Intervention Name(s)
colposcopic biopsy
Intervention Description
Screening, week 36, and week 52.
Primary Outcome Measure Information:
Title
Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
Description
Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Time Frame
52 weeks from study entry
Title
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
Description
Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Time Frame
Screening/Week 0, Weeks 2, 10, 26, and 52.
Title
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
Description
Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Time Frame
Week 28
Title
Number of Patients With a Significant Increase in HIV Viral Load
Description
Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions
Time Frame
Screening/week 0, weeks, 2, 10, 26 and 52
Title
Number of Patients With Detectable Antibodies to HPV-6
Description
Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Time Frame
28 weeks
Title
Number of Patients With Detectable Antibodies to HPV-11
Description
Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Time Frame
28 weeks
Title
Number of Patients With Detectable Antibodies to HPV-18
Description
Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
Time Frame
28 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 entry No known history of high-grade CIN or cervical cancer PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Palefsky, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
N. Kumarasamy, MD
Organizational Affiliation
YRG Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
YRG Care
City
Chennai
ZIP/Postal Code
600113
Country
India

12. IPD Sharing Statement

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Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

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