Impact of an HPV Vaccine in HIV-Infected Young Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00710593
First received: July 2, 2008
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.


Condition Intervention Phase
HIV Infection
Biological: HPV vaccine for strains -6, -11, -16, and -18
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Immunogenicity of the HPV-6, -11, -16, -18 vaccine after vaccine dose #3 as measured by the geometric mean titers to HPV-6, -11, -16, and -18. [ Time Frame: Weeks 28 and 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the immunogenicity of the HPV-6, -11, -16, -18 vaccine four weeks post vaccine dose #3. [ Time Frame: Weeks 28 and 48 ] [ Designated as safety issue: No ]
  • To determine whether the HPV-6, -11, -16, -18 vaccine is well-tolerated and safe in HIV-infected young women when given in a standard dosing regimen. [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 24, Week 28, and Week 48 ] [ Designated as safety issue: Yes ]
  • To examine whether vaccine immunogenicity or safety varies as a function of subject age and/or treatment status at the time of vaccination. [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 24, Week 28, and Week 48 ] [ Designated as safety issue: Yes ]
  • Persistence of the immune response 24 weeks post vaccine dose #3. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • The impact of vaccination on acquisition of vaccine and nonvaccine HPV types 24 and 48 weeks after initial vaccination among those who seroconvert. [ Time Frame: Weeks 24 and 28 ] [ Designated as safety issue: No ]
  • To characterize young women's risk perceptions, sexual behaviors, and STI diagnosis over the 48 weeks after initial vaccination. [ Time Frame: Day 1 through Week 48 ] [ Designated as safety issue: Yes ]
  • To compare AE reporting using a telephone response system vs. a vaccine report card. [ Time Frame: Day 1 through Week 48 ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: February 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Biological: HPV vaccine for strains -6, -11, -16, and -18
All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Active Comparator: B
Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Biological: HPV vaccine for strains -6, -11, -16, and -18
All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

  Eligibility

Ages Eligible for Study:   16 Years to 23 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Young women age 16 years and 0 days to 23 years and 364 days
  • HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA > 1,000 copies/ml
  • HIV treatment history that falls in one of the following categories:

Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry

  • Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on ARV medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
  • Anticipated ability and willingness to complete all study vaccines and evaluations
  • Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria:

  • History of any prior vaccination with an HPV vaccine
  • Active anogenital warts within three months prior to study entry) or history of CIN 2/3 (ever, must be documented by colposcopy)
  • Previous allergic reaction to any constituents of the HPV vaccine
  • Pregnancy
  • Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
  • Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
  • Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the ATN Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
  • Receipt of any routine vaccine within four weeks prior to study entry
  • Receipt of any immune globulin or plasma product within six months prior study entry
  • Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
  • Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
  • Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
  • Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
  • Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for > 2 consecutive weeks)
  • Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
  • Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
  • If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710593

Locations
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Childrens Diagnostic & Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami School of Medicine
Miami, Florida, United States, 33101
USF College of Medicine
Tampa, Florida, United States, 33606
United States, Illinois
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States, 60612
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Puerto Rico
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Investigators
Study Chair: Jessica A. Kahn, M.D., M.P.H. Adolescent Trials Network
Study Chair: Kathleen Squires, M.D. Adolescent Trials Network
  More Information

Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00710593     History of Changes
Other Study ID Numbers: ATN 064
Study First Received: July 2, 2008
Last Updated: October 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Adolescent Medicine Trials Network for HIV/AIDS Interventions
Highly-active antiretroviral therapy
Human papillomavirus
HPV vaccine
Reaching for Excellence in Adolescent Care and Health
Merck Research Laboratory
Telephone Response System

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 27, 2014