NCT00667563

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

Completed Phase 1 Results posted Last updated 19 February 2024

What this trial tests

Phase 1 trial testing quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in Cervical Cancer in 150 participants. Completed in 1 November 2012.

Timeline

1 August 2009

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	AIDS Malignancy Consortium
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	150
Start date	1 August 2009
Primary completion	1 November 2012
Estimated completion	1 November 2012
Sites	1 location across India

Drugs / interventions tested

• quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
• DNA analysis
• polymerase chain reaction
• cytology specimen collection procedure
• colposcopic biopsy

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Nonneoplastic Condition — all drugs for Nonneoplastic Condition →
• Precancerous Condition — all drugs for Precancerous Condition →

Sponsor

AIDS Malignancy Consortium

Who can join

Adults 18 to 120, female only, with Cervical Cancer or Nonneoplastic Condition. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. HPV pathogenesis, various types of vaccines, safety concern, prophylactic and therapeutic applications to control cervical cancer, and future perspective.
   Ashique S, Hussain A, Fatima N, Altamimi MA. · · 2023 · cited 14× · PMID 37363362 · DOI 10.1007/s13337-023-00824-z
2. Post-Immune Antibodies in HIV-1 Infection in the Context of Vaccine Development: A Variety of Biological Functions and Catalytic Activities.
   Timofeeva A, Sedykh S, Nevinsky G. · · 2022 · cited 12× · PMID 35335016 · DOI 10.3390/vaccines10030384
3. Exploring the Intricacies of Cervical Intraepithelial Neoplasia and Its Connection with HPV: A Narrative Review.
   Karimi P, Reza Hosseini SM, Mousavian Hiagh ZS, Aboulhassanzadeh S, et al · · 2024 · cited 4× · PMID 39759206 · DOI 10.18502/ijph.v53i12.17310