Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

Phase 2

Completed

• Conditions: Infection; Precancerous Condition
• Interventions: Biological: Gardasil

• Registration Number: NCT00513526
• Lead Sponsor: AIDS Malignancy Consortium

Brief Summary

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.

PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

Detailed Description

OBJECTIVES:

Primary

* To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.

* To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.

Secondary

* To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.

* To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.

* To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.

* To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

* To evaluate prevalent and incident HPV infections in the anal canal.

* To evaluate cytological and histological abnormalities in the anal canal.

* To evaluate prevalent and incident HPV infections in the oral cavity.

* To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Study Timeline

• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-08
• Study Start: 2007-11
• Primary Completion: 2010-05
• Results First Submitted: 2011-06-28
• Results First Submitted QC: 2011-06-28
• Results First Posted: 2011-07-26
• Study Completion: 2011-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gardasil	Gardasil	Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.

Primary Outcome Measures

Name	Time	Method
Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline	Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline	Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline	Week 28
Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline	Week 28
Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine	All study visits	Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine

Secondary Outcome Measures

Name	Time	Method
HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status	weeks 0, 28, and 76	HPV antibody titers to type 16 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Longitudinal Changes in CD4+ Cell Count From Baseline	Week 0, 4, 12, 28	CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status	weeks 0, 28, and 76	HPV antibody titers to type 11 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series	Weeks 0, 28 and 76
Longitudinal Changes in Plasma HIV-1 RNA From Baseline	Week 0, 4, 12, 28	Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status	weeks 0, 28, and 76	HPV antibody titers to type 6 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters
HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status	weeks 0, 28, and 76	HPV antibody titers to type 18 at baseline and weeks 28 and 76 according to baseline seropositive status will measured in Milli-Merck units per milliliters

Trial Locations

Locations (8)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

New York Weill Cornell Cancer Center at Cornell University; 🇺🇸 New York, New York, United States

Laser Surgery Care; 🇺🇸 New York, New York, United States

UCLA Clinical AIDS Research and Education (CARE) Center; 🇺🇸 Los Angeles, California, United States

Boston University Cancer Research Center; 🇺🇸 Boston, Massachusetts, United States

Benaroya Research Institute at Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States