Cervical CancerPhase 1NCT00667563
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
A Phase 1 study testing quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis and polymerase chain reaction in people with Cervical Cancer and Nonneoplastic Condition, run by AIDS Malignancy Consortium at 1 site in India.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Cervical Cancer, Nonneoplastic Condition, Precancerous Condition
- What is being tested?
- quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis and polymerase chain reaction
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2009to Nov 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis, polymerase chain reaction, cytology specimen collection procedure, colposcopic biopsy
- Keywords
- human papilloma virus infection, cervical cancer, cervical intraepithelial neoplasia, HIV infection
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, Papillomavirus Infections, Uterine Cervical Dysplasia, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccineBiological
Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.
DNA analysisGenetic
Also called HIV viral load test and HPV neutralization assays.
Weeks 0, 2, 10, 26, and 52.
polymerase chain reactionGenetic
Screening, week 36, and week 52.
cytology specimen collection procedureOther
Screening, week 36, and week 52.
colposcopic biopsyProcedure or surgery
Screening, week 36, and week 52.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startAug 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Joel Palefsky, MD, Study chair, University of California, San FranciscoN. Kumarasamy, MD, Principal investigator, YRG Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667563
- Sponsor's protocol ID
- AMC-054
- Other IDs
- U01CA121947, CDR0000593634
- Status last verified
- Feb 2024
- First submitted
- 25 Apr 2008
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00667563
- Acronym / sponsor ID
- AMC-054
- Keywords
- human papilloma virus infection, cervical cancer, cervical intraepithelial neoplasia, HIV infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Study start
- Aug 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 11 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gardasil Vaccination | Experimental | 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 biopsyVaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccineVaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24. | Biological | Gardasil Vaccination |
| DNA analysisAlso: HIV viral load test and HPV neutralization assays.Weeks 0, 2, 10, 26, and 52. | Genetic | Gardasil Vaccination |
| polymerase chain reactionScreening, week 36, and week 52. | Genetic | Gardasil Vaccination |
| cytology specimen collection procedureScreening, week 36, and week 52. | Other | Gardasil Vaccination |
| colposcopic biopsyScreening, week 36, and week 52. | Procedure or surgery | Gardasil Vaccination |
Primary outcome
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
Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients
Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count
Time frame: Screening/Week 0, Weeks 2, 10, 26, and 52.
Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests
Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28
Time frame: Week 28
Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline
Number of Patients With a Significant Increase in HIV Viral Load
Time frame: Screening/week 0, weeks, 2, 10, 26 and 52
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
Number of Patients With Detectable Antibodies to HPV-6
Time frame: 28 weeks
Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline
Number of Patients With Detectable Antibodies to HPV-11
Time frame: 28 weeks
Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline
Number of Patients With Detectable Antibodies to HPV-18
Time frame: 28 weeks
Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary for AMC-054Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Palefsky, MD study chair
University of California, San Francisco
N. Kumarasamy, MD principal investigator
YRG Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, DNA analysis and polymerase chain reaction in people with Cervical Cancer and Nonneoplastic Condition, run by AIDS Malignancy Consortium at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.