Clinical trial NCT01206556: IMPAACT P1085: Human Papilloma Virus (HPV) Type-Specific Antibody
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papilloma Virus, Human
Keywords: HUMAN PAPILLOMA VIRUS
HPV
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Merck Sharp & Dohme LLC
First posted: 2010-09-22
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 208 weeks (4 Years)
Secondary outcomes:
measure: 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.
timeFrame: 4 years
measure: 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.
timeFrame: 4 years
measure: 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.
timeFrame: 5 years after completion
measure: 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.
timeFrame: 4 years
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Children's Hospital Long Beach (5093)
state: California
city: Los Angeles
country: United States
facility: USC/Los Angeles County Medical Center NICHD CRS (5048)
state: California
city: Los Angeles
country: United States
facility: UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
state: California
city: San Diego
country: United States
facility: Univ of California, San Diego (4601)
state: California
city: San Francisco,
country: United States
facility: Univ. of California San Francisco NICHD CRS
state: California
city: Aurora
country: United States
facility: Univ. of Colorado Denver NICHD CRS (5052)
state: Colorado
city: Washington
country: United States
facility: Children's National Med. Ctr. Washington DC NICHD CRS (5015)
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: South Florida CDC Ft. Lauderdale NICHD CRS (5055)
state: Florida
city: Miami
country: United States
facility: Univ of Miami Pediatric/Perinatal HIV/AIDS (4201)
state: Florida
city: Chicago
country: United States
facility: Rush University Cook County Hospital NICHD CRS (5083)
state: Illinois
city: Chicago
country: United States
facility: Chicago Children's CRS (4001)
state: Illinois
city: Boston
country: United States
facility: Children's Hospital of Boston (5009)
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center Ped. HIV Program NICHD CRS (5011)
state: Massachusetts
city: Worcester
country: United States
facility: WNE Maternal Pediatric Adolescent AIDS CRS (7301)
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
state: Michigan
city: Newark
country: United States
facility: New Jersey Medical School (NJ) (2802)
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital (6901)
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center Bronx (5013)
state: New York
city: New York
country: United States
facility: New York University NY (5012)
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook (5040)
state: New York
city: Houston
country: United States
facility: Texas Children's Hosp / Baylor Univ (3801)
state: Texas
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp. PR NICHD CRS (5031)
Study officials:
affiliation: University of Colorado, Denver
name: Myron J Levin, MD
role: STUDY_CHAIR
References:
citation: 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.