Clinical trial NCT00710593: Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
Official title: Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Keywords: Highly-active antiretroviral therapy
Human papillomavirus
HPV vaccine
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-07-04
Enrollment: 99
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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 polymerase chain reaction (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 antiretroviral (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 cervical intraepithelial neoplasia (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 Adolescent Medicine Trials Network for HIV/AIDS Interventions (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

Primary outcomes:
measure: HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
timeFrame: Week 28
measure: HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)
timeFrame: Week 28
measure: HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)
timeFrame: Week 28
measure: HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)
timeFrame: Week 28
Secondary outcomes:
measure: Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6
timeFrame: Week 28
measure: Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11
timeFrame: Week 28
measure: Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16
timeFrame: Week 28
measure: Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18
timeFrame: Week 28
measure: Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine
timeFrame: Entry, Week 8, and Week 24
measure: Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.
timeFrame: Week 48
measure: Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.
timeFrame: Week 48
measure: Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.
timeFrame: Week 48
measure: Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.
timeFrame: Week 48
measure: Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).
timeFrame: Week 24
measure: Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).
timeFrame: Week 24
measure: Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).
timeFrame: Week 24
measure: Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).
timeFrame: Week 24
measure: Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).
timeFrame: Week 48
measure: Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).
timeFrame: Week 48
measure: Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).
timeFrame: Week 48
measure: Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).
timeFrame: Week 48
measure: Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination
timeFrame: Week 48
measure: Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)
timeFrame: Week 48
measure: Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.
timeFrame: Day 1 through Week 24
measure: Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).
timeFrame: Day 1 through Week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: Washington, D.C.
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Childrens Diagnostic & Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: USF College of Medicine
state: Florida
city: Chicago
country: United States
facility: Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
state: Illinois
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: The Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St Jude Childrens Research Hospital
state: Tennessee
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
affiliation: Adolescent Trials Network
name: Jessica A. Kahn, M.D., M.P.H.
role: STUDY_CHAIR
affiliation: Adolescent Trials Network
name: Kathleen Squires, M.D.
role: STUDY_CHAIR
References:
citation: Kahn JA, Xu J, Zimet GD, Liu N, Gonin R, Dillard ME, Squires K; Adolescent Trials Network for HIV/AIDS Interventions. Risk perceptions after human papillomavirus vaccination in HIV-infected adolescents and young adult women. J Adolesc Health. 2012 May;50(5):464-70. doi: 10.1016/j.jadohealth.2011.09.005. Epub 2011 Nov 4.
citation: Kahn JA, Burk RD, Squires KE, Kapogiannis BG, Rudy B, Xu J, Gonin R, Liu N, Worrell C, Wilson CM. Prevalence and risk factors for HPV in HIV-positive young women receiving their first HPV vaccination. J Acquir Immune Defic Syndr. 2012 Nov 1;61(3):390-9. doi: 10.1097/QAI.0b013e3182676fe3.
citation: Kahn JA, Xu J, Kapogiannis BG, Rudy B, Gonin R, Liu N, Wilson CM, Worrell C, Squires KE. Immunogenicity and safety of the human papillomavirus 6, 11, 16, 18 vaccine in HIV-infected young women. Clin Infect Dis. 2013 Sep;57(5):735-44. doi: 10.1093/cid/cit319. Epub 2013 May 10.