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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


N/A
N/A
N/A
Open (Enrolling)
Both
Papilloma Virus, Human

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Trial Information

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


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(manufacturer's data, unpublished), but there is no such information available from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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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

Outcome Description:

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.

Outcome Time Frame:

208 weeks (4 Years)

Safety Issue:

No

Principal Investigator

Myron J Levin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

IMPAACT P1085

NCT ID:

NCT01206556

Start Date:

May 2010

Completion Date:

July 2014

Related Keywords:

  • Papilloma Virus, Human
  • HUMAN PAPILLOMA VIRUS
  • HPV
  • Papilloma
  • Virus Diseases

Name

Location

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