Phase 1
N=150
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
Cervical Cancer · Nonneoplastic Condition · Precancerous Condition
Bottom Line
View on ClinicalTrials.gov: NCT00667563 ↗Enrolled (actual)
150
Serious AEs
2.7%
Results posted
Apr 2014
Primary outcome: Primary: Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 — 6.0 Grade 3/4 adverse events per 100 patient
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological); DNA analysis (Genetic); polymerase chain reaction (Genetic); cytology specimen collection procedure (Other); colposcopic biopsy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0 |
6.0 | — |
| PRIMARY Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count |
11 | — |
| PRIMARY Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28 |
95 | — |
| PRIMARY Number of Patients With a Significant Increase in HIV Viral Load |
7 | — |
| PRIMARY Number of Patients With Detectable Antibodies to HPV-6 |
88 | — |
| PRIMARY Number of Patients With Detectable Antibodies to HPV-11 |
110 | — |
| PRIMARY Number of Patients With Detectable Antibodies to HPV-18 |
94 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00667563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.