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CompletedNCT00667563Updated Mar 19, 2024Results posted

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

A Phase 1 interventional study of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine and DNA analysis in Cervical Cancer, Nonneoplastic Condition and Precancerous Condition, sponsored by AIDS Malignancy Consortium. Completed at 1 site in India. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by AIDS Malignancy Consortium · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Cancer
  • Nonneoplastic Condition
  • Precancerous Condition

Keywords

  • human papilloma virus infection
  • cervical cancer
  • cervical intraepithelial neoplasia
  • HIV infection
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 10 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

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

Interventions

  • Biologicalquadrivalent 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.

  • GeneticDNA analysis

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

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

  • Geneticpolymerase chain reaction

    Screening, week 36, and week 52.

  • Othercytology specimen collection procedure

    Screening, week 36, and week 52.

  • Procedurecolposcopic biopsy

    Screening, week 36, and week 52.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 52 weeks from study entry

  2. 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

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

  3. 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

    Time frame: Week 28

  4. 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

    Time frame: Screening/week 0, weeks, 2, 10, 26 and 52

  5. 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

    Time frame: 28 weeks

  6. 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

    Time frame: 28 weeks

  7. Number of Patients With Detectable Antibodies to HPV-18

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

    Time frame: 28 weeks

07

Results

Posted Apr 11, 2014

Participant flow

Participant flow — Overall Study
MilestoneGardasil Vaccination
Started150
Completed126
Not completed24
Withdrew: Protocol violation24

Outcome measures

PrimarySafety, 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

Time frame:
52 weeks from study entry
Reported as:
Number · Grade 3/4 adverse events per 100 patient
Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0
Grade 3/4 adverse events per 100 patientGardasil Vaccination
Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.06.0 (3.12 to 11.58)
PrimaryNumber 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

Time frame:
Screening/Week 0, Weeks 2, 10, 26, and 52.
Reported as:
Number · participants
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
participantsGardasil Vaccination
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count11 (3.77 to 12.91)
PrimaryNumber 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

Time frame:
Week 28
Reported as:
Number · participants
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
participantsGardasil Vaccination
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 2895
PrimaryNumber 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

Time frame:
Screening/week 0, weeks, 2, 10, 26 and 52
Reported as:
Number · participants
Number of Patients With a Significant Increase in HIV Viral Load
participantsGardasil Vaccination
Number of Patients With a Significant Increase in HIV Viral Load7 (1.95 to 9.63)
PrimaryNumber of Patients With Detectable Antibodies to HPV-6

Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline

Time frame:
28 weeks
Reported as:
Number · participants
Number of Patients With Detectable Antibodies to HPV-6
participantsGardasil Vaccination
Number of Patients With Detectable Antibodies to HPV-688
PrimaryNumber of Patients With Detectable Antibodies to HPV-11

Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline

Time frame:
28 weeks
Reported as:
Number · participants
Number of Patients With Detectable Antibodies to HPV-11
participantsGardasil Vaccination
Number of Patients With Detectable Antibodies to HPV-11110
PrimaryNumber of Patients With Detectable Antibodies to HPV-18

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

Time frame:
28 weeks
Reported as:
Number · participants
Number of Patients With Detectable Antibodies to HPV-18
participantsGardasil Vaccination
Number of Patients With Detectable Antibodies to HPV-1894

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gardasil Vaccination—4/150 (2.7%)145/150 (96.7%)
Most frequent serious events
Most frequent serious events
EventGardasil Vaccination
AnemiaBlood and lymphatic system disorders1/150
FeverGeneral disorders1/150
MeningitisInfections and infestations1/150
Lung InfectionInfections and infestations1/150
LeptospirosisInfections and infestations1/150
SeizureNervous system disorders1/150
Most frequent other events
Showing 10 of 20
Most frequent other events
EventGardasil Vaccination
CoughReproductive system and breast disorders59/150
Pain in extremityMusculoskeletal and connective tissue disorders45/150
Upper Respiratory InfectionInfections and infestations44/150
PruritusSkin and subcutaneous tissue disorders41/150
Abdominal painGastrointestinal disorders35/150
HeadacheNervous system disorders34/150
FatigueGeneral disorders27/150
Back painMusculoskeletal and connective tissue disorders27/150
Skin InfectionInfections and infestations26/150
MyalgiaMusculoskeletal and connective tissue disorders25/150

Baseline characteristics

Enrolled in study

Age, Continuous
Age, Continuous(years)Gardasil Vaccination
Mean30.8 ± 5.2
Sex: Female, Male
Sex: Female, Male(Participants)Gardasil Vaccination
Female150
Male0
08

Study locations

1 site
  • YRG Care
    Chennai, 600113, India
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00667563
Lead sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC
Responsible party
Sponsor
First posted
Apr 28, 2008
Start date
Aug 2009
Primary completion
Nov 2012
Completion
Nov 2012
Results posted
Apr 11, 2014
Last update
Mar 19, 2024

Study contacts

Joel Palefsky, MD
study chair · University of California, San Francisco
N. Kumarasamy, MD
principal investigator · YRG Care

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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