Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
This study has been completed.
Sponsor:
AIDS Malignancy Clinical Trials Consortium
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00667563
First received: April 25, 2008
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Nonneoplastic Condition Precancerous Condition |
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Genetic: DNA analysis Genetic: polymerase chain reaction Other: cytology specimen collection procedure Procedure: colposcopic biopsy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Human Papillomaviruses
U.S. FDA Resources
Further study details as provided by AIDS Malignancy Clinical Trials Consortium:
Primary Outcome Measures:
- Safety, in terms of grade 3 or 4 adverse events attributed to the vaccine, according to NCI CTCAE v3.0 [ Time Frame: 52 weeks from study entry ] [ Designated as safety issue: Yes ]
- Significant decrease (at the 0.05 significance level) in CD4+ cell count or HIV RNA rise from baseline of ≥ 1.0 log10 in the level of quantification (or > 200 copies/mL in patients < 50 years old at study entry) [ Time Frame: Screening/Week 0, Weeks 2, 10, 26, and 52. ] [ Designated as safety issue: No ]
- Detectable HPV antibody to HPV 16, 18, 6 or 11 at 1 month after the completion of HPV vaccination series (week 28) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HPV antibody titers to types 6, 11, 16, and 18 at baseline and at weeks 8, 24, and 52 [ Time Frame: baseline and at weeks 8, 24, and 52 ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| Study Start Date: | August 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gardasil Vaccination
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
|
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
Genetic: DNA analysis
Weeks 0, 2, 10, 26, and 52.
Other Name: HIV viral load test and HPV neutralization assays.
Genetic: polymerase chain reaction
Screening, week 36, and week 52.
Other: cytology specimen collection procedure
Screening, week 36, and week 52.
Procedure: colposcopic biopsy
Screening, week 36, and week 52.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667563
Locations
| India | |
| YRG Care | |
| Chennai, India, 600113 | |
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
Investigators
| Study Chair: | Joel Palefsky, MD | University of California, San Francisco |
| Principal Investigator: | N. Kumarasamy, MD | YRG Care |
More Information
Additional Information:
No publications provided
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT00667563 History of Changes |
| Other Study ID Numbers: | CDR0000593634, U01CA121947, AMC-054 |
| Study First Received: | April 25, 2008 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board India: Drugs Controller General of India India: Indian Council of Medical Research India: Institutional Review Board |
Keywords provided by AIDS Malignancy Clinical Trials Consortium:
|
human papilloma virus infection cervical cancer cervical intraepithelial neoplasia HIV infection |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms HIV Seropositivity Precancerous Conditions Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013