Impact of an HPV Vaccine in HIV-Infected Young Women

HIV Infection Clinical Trial

Official title:

Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710593
• Other study ID #: ATN 064
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2008
• Last updated: October 26, 2012
• Start date: February 2008
• Est. completion date: February 2011

Study information

• Verified date: October 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 23 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection

Intervention

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).

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, Medical Sciences Campus	San Juan
United States	University of Maryland	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Childrens Memorial Hospital	Chicago	Illinois
United States	Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital	Chicago	Illinois
United States	Childrens Diagnostic & Treatment Center	Fort Lauderdale	Florida
United States	Childrens Hospital of Los Angeles	Los Angeles	California
United States	St Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	USF College of Medicine	Tampa	Florida
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Weeks 28 and 48	No
Secondary	To determine the immunogenicity of the HPV-6, -11, -16, -18 vaccine four weeks post vaccine dose #3.		Weeks 28 and 48	No
Secondary	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.		Day 1, Week 4, Week 8, Week 12, Week 24, Week 28, and Week 48	Yes
Secondary	To examine whether vaccine immunogenicity or safety varies as a function of subject age and/or treatment status at the time of vaccination.		Day 1, Week 4, Week 8, Week 12, Week 24, Week 28, and Week 48	Yes
Secondary	Persistence of the immune response 24 weeks post vaccine dose #3.		Week 48	No
Secondary	The impact of vaccination on acquisition of vaccine and nonvaccine HPV types 24 and 48 weeks after initial vaccination among those who seroconvert.		Weeks 24 and 28	No
Secondary	To characterize young women's risk perceptions, sexual behaviors, and STI diagnosis over the 48 weeks after initial vaccination.		Day 1 through Week 48	Yes
Secondary	To compare AE reporting using a telephone response system vs. a vaccine report card.		Day 1 through Week 48	No

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions