Clinical trial · Interventional
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
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
NCT00667563CI-TRIAL-00075176completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Nonneoplastic Condition | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colposcopic biopsy | Procedure | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| DNA analysis | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gardasil Vaccination
- description
- Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
- interventionNames
- 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
Primary outcomes (7)
- measure
- Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
- timeFrame
- 52 weeks from study entry
- description
- Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.