IMPAACT P1085: Human Papilloma Virus (HPV) Type-Specific Antibody (HPV)

Duration of Human Papilloma Virus (HPV) Type-Specific Antibody After Administration of Quadrivalent HPV Vaccine (QHPV) to HIV-1 Infected Children Previously Enrolled in IMPAACT P1047

This study is being done to evaluate how long the immune response from the Human Papilloma Virus (HPV) vaccine you / your child received persists. The immune response occurred after immunization and is what protects you/your child from HPV disease. You / your child received this vaccine as part of an earlier study (P1047). The vaccine is called Human Papillomavirus Vaccine (QHPV Vaccine, also known as GARDASIL®). The study will check to see if the protective effects (called "antibodies") produced by the vaccine have lasted, and for how long these effects will continue to last. You will not be given any medications or vaccines as part of this follow-up study.

Study Overview

• Status: Completed
• Conditions: Papilloma Virus, Human

Detailed Description

Genital Human Papilloma Virus (HPV) infection is the most common sexually transmitted infection (STI) in the United States and worldwide. Over 50% of sexually active adolescents will become infected with HPV. HPV infection is strongly associated with the development of anogenital dysplasias and invasive cancers. Because HPV is a STI, optimal prevention in women will depend on prevention in their partners as well. Males remain a significant reservoir of HPV and vaccinating them will be essential for rapidly preventing transmission of HPV in the community.

P1085 is a sub study of P1047, which investigated the safety and immunogenicity of Quadrivalent HPV (QHPV) in HIV-infected girls and boys, age 7 to <12 years of age. This study was a placebo-controlled trial that compared a recommended three dose schedule of QHPV in one study arm (Arm A) with an arm that received placebo (Arm B). P1047 has thus far demonstrated that QHPV can be safely administered to human immunodeficiency virus (HIV)-infected boys and girls and will stimulate seroconversion in more than 95% of vaccinees. However, these antibody levels were 30-50% lower than those achieved in children without HIV infection. Since levels of vaccine-induced antibodies decline with time after vaccination, it is uncertain if vaccine-induced immunity will be life-long. This concern is supported by some evidence that naturally acquired HPV-specific antibody might decline to a level that will permit re-infection. Comparative persistence data for HPV-specific antibody is available for 5-6 years after vaccination of almost 1000 children without HIV infection (manufacturer's data, unpublished), but there is no such information available from HIV-infected vaccinees.

We seek to determine the long-term durability and kinetics of the vaccine-induced HPV-type-specific antibody and CMI responses in HIV-infected children that were, and are being, immunized in P1047. These subjects are a unique cohort that will allow us to approach this specific clinical issue.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • San Juan City Hosp. PR NICHD CRS (5031)
• United States
  • California
    • Long Beach, California, United States, 90806
      • Miller Children's Hospital Long Beach (5093)
    • Los Angeles, California, United States, 90095
      • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
    • Los Angeles, California, United States, 90033
      • USC/Los Angeles County Medical Center NICHD CRS (5048)
    • San Diego, California, United States, 92103
      • Univ of California, San Diego (4601)
    • San Francisco,, California, United States, 94117
      • Univ. of California San Francisco NICHD CRS
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ. of Colorado Denver NICHD CRS (5052)
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Med. Ctr. Washington DC NICHD CRS (5015)
  • Florida
    • Ft. Lauderdale, Florida, United States, 33316
      • South Florida CDC Ft. Lauderdale NICHD CRS (5055)
    • Miami, Florida, United States, 33136
      • Univ of Miami Pediatric/Perinatal HIV/AIDS (4201)
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Chicago Children's CRS (4001)
    • Chicago, Illinois, United States, 60612
      • Rush University Cook County Hospital NICHD CRS (5083)
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center Ped. HIV Program NICHD CRS (5011)
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital of Boston (5009)
    • Worcester, Massachusetts, United States, 01605
      • WNE Maternal Pediatric Adolescent AIDS CRS (7301)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School (NJ) (2802)
  • New York
    • Bronx, New York, United States, 10457
      • Bronx-Lebanon Hospital (6901)
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center Bronx (5013)
    • New York, New York, United States, 10016
      • New York University NY (5012)
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
    • Stony Brook, New York, United States, 11794-8111
      • SUNY Stony Brook (5040)
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hosp / Baylor Univ (3801)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This will be limited to subjects who were enrolled into IMPAACT P1047 and who completed the scheduled vaccine doses for their designated arm.

Description

Inclusion Criteria:

• Previous enrollment in P1047
• Completion of the P1047 scheduled vaccine doses for their designated arm.
• Parent or legal guardian able and willing to provide signed informed consent
• Subjects should be between 1 and 2 years following their last HPV vaccination.

Exclusion Criteria:

• Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.
• Administration of a globulin-containing product within 90 days prior to enrollment.
• Receipt of an additional dose of Merck HPV vaccine other than that administered for the P1047 study.
• Receipt of GSK HPV vaccine.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047	To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047 and compare them to published levels of QHPV-induced antibody levels present in age-similar children IMPAACT P1085 without HIV infection at these time intervals after QHPV vaccination.	208 weeks (4 Years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the decline over the study interval in HPV type-specific antibody in subjects who received four doses of QHPV (Arm A) with those who received three doses of vaccine (Arm B) in P1047.	To compare the decline over the study interval in HPV type-specific antibody in subjects who received four doses of QHPV (Arm A) with those who received three doses of vaccine (Arm B) in P1047.	4 years
Determining the magnitude of HPV-specific antibody at different times after QHPV vaccination as a function of immune status (as defined by CD4 count and CD4 percent) and plasma HIV viral load.	To determine the magnitude of HPV-specific antibody at different times after QHPV vaccination as a function of immune status (as defined by CD4 count and CD4%) and plasma HIV viral load.	4 years
Determining the persistence of HPV-specific CMI at 2, 3.5, and 5 years after completion of the QHPV schedule for each of the arms in P1047.	To determine the persistence of HPV-specific CMI at 2, 3.5, and 5 years after completion of the QHPV schedule for each of the arms in P1047.	5 years after completion
Evaluating potential associations of HIV plasma RNA, lymphocyte immunophenotypes, HPV-specific memory B cell lymphocytes and HPV-specific CMI with the decay of anti-HPV antibody titers.	To evaluate potential associations of HIV plasma RNA, lymphocyte immunophenotypes, HPV-specific memory B cell lymphocytes and HPV-specific CMI with the decay of anti-HPV antibody titers.	4 years

Collaborators and Investigators

• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Merck Sharp & Dohme LLC
• Investigators: Study Chair: Myron J Levin, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Levin MJ, Huang S, Moscicki AB, Song LY, Read JS, Meyer WA, Saah AJ, Richardson K, Weinberg A; IMPAACT P1085 Protocol Team. Four-year persistence of type-specific immunity after quadrivalent human papillomavirus vaccination in HIV-infected children: Effect of a fourth dose of vaccine. Vaccine. 2017 Mar 23;35(13):1712-1720. doi: 10.1016/j.vaccine.2017.02.021. Epub 2017 Feb 24.

Helpful Links

• IMPAACT Network Web Site

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 22, 2010

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: HPV; HUMAN PAPILLOMA VIRUS
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IMPAACT P1085; U01AI068632 (U.S. NIH Grant/Contract)