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

NCT00667563 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: AMC-054U01CA121947CDR0000593634
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Nonneoplastic Condition; Precancerous Condition

Keywords

human papilloma virus infection; cervical cancer; cervical intraepithelial neoplasia; HIV infection

Outcome Measures

Primary Outcomes (7)

• 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

  52 weeks from study entry

• 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

  Screening/Week 0, Weeks 2, 10, 26, and 52.

• 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

  Week 28

• 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

  Screening/week 0, weeks, 2, 10, 26 and 52

• 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

  28 weeks

• 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

  28 weeks

• Number of Patients With Detectable Antibodies to HPV-18

  Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline

  28 weeks

Study Arms (1)

Gardasil Vaccination

EXPERIMENTAL

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; Genetic: DNA analysis; Genetic: polymerase chain reaction; Other: cytology specimen collection procedure; Procedure: colposcopic biopsy

Interventions

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine BIOLOGICAL

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

Gardasil Vaccination

DNA analysis GENETIC

Weeks 0, 2, 10, 26, and 52.

Also known as: HIV viral load test and HPV neutralization assays.

Gardasil Vaccination

polymerase chain reaction GENETIC

Screening, week 36, and week 52.

Gardasil Vaccination

cytology specimen collection procedure OTHER

Screening, week 36, and week 52.

Gardasil Vaccination

colposcopic biopsy PROCEDURE

Screening, week 36, and week 52.

Gardasil Vaccination

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (1)

YRG Care

Chennai, 600113, India

Location

Related Links

• Clinical trial summary for AMC-054

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Papillomavirus Infections; Uterine Cervical Dysplasia; HIV Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Results Point of Contact

• Title: Jeannette Y. Lee
• Organization: AMC

jylee@uams.edu

5015266712

Study Officials

• Joel Palefsky, MD

  University of California, San Francisco

  STUDY CHAIR

• N. Kumarasamy, MD

  YRG Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 28, 2008
• Study Start: August 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 19, 2024
• Results First Posted: April 11, 2014

Record last verified: 2024-02

Locations

IN (1)