Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

NCT00710593 | Completed Phase 2 Results DMC

• 1 other identifier: ATN 064
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 14

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.

Conditions

HIV Infection

Keywords

Highly-active antiretroviral therapy; Human papillomavirus; HPV vaccine

Outcome Measures

Primary Outcomes (4)

• HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)

  The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.

  Week 28

• HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)

  The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.

  Week 28

• HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)

  The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.

  Week 28

• HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)

  The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.

  Week 28

Secondary Outcomes (21)

• 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

  Week 28

• 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

  Week 28

• 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

  Week 28

• 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

  Week 28

• Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine

  Entry, Week 8, and Week 24

Study Arms (2)

A: HAART naive or no HAART in past 6 months

ACTIVE COMPARATOR

Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (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

B: HAART atleast 6 months/ 2 viral loads <400 in last 6 months

ACTIVE COMPARATOR

Participants who have been receiving highly active antiretroviral therapy (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

Interventions

HPV vaccine for strains -6, -11, -16, and -18 BIOLOGICAL

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).

A: HAART naive or no HAART in past 6 months; B: HAART atleast 6 months/ 2 viral loads <400 in last 6 months

Eligibility Criteria

• Age: 16 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (14)

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Childrens Diagnostic & Treatment Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

USF College of Medicine

Tampa, Florida, 33606, United States

Location

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, 60612, United States

Location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Mount Sinai Medical Center

New York, New York, 10128, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

University of Puerto Rico, Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (3)

• 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.

  PMID: 22525109 RESULT

• 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.

  PMID: 22820809 RESULT

• 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.

  PMID: 23667266 RESULT

Related Links

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

MeSH Terms

Conditions

HIV Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

The small number of participants (99 started and 79 completed the study) limits generalizability of safety/tolerability data.

Results Point of Contact

• Title: Dr. Bob Harris
• Organization: Westat

bobharris@westat.com

301-251-1500

Study Officials

• Jessica A. Kahn, M.D., M.P.H.

  Adolescent Trials Network

  STUDY CHAIR

• Kathleen Squires, M.D.

  Adolescent Trials Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 2, 2017
• Results First Posted: May 22, 2017

Record last verified: 2017-04

Locations

PR (1); US (13)