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

Papilloma Virus, Human Clinical Trial

— HPV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206556
• Other study ID #: IMPAACT P1085
• Secondary ID: U01AI068632
• Status: Completed
• Phase: N/A
• First received: September 20, 2010
• Last updated: March 30, 2015
• Start date: May 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2015
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Papilloma
• Papilloma Virus, Human

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Merck Sharp & Dohme Corp., National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No