Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
HIV InfectionsSexually Transmitted Diseases
Interventions
BIOLOGICAL

Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)

QHPV at week 0, 8, 24 and 96.

OTHER

Placebo/QHPV

Placebo at week 0, 8, 24 and QHPV at week 96, 104, 120.

Trial Locations (34)

10016

Nyu Ny Nichd Crs, New York

10457

Bronx-Lebanon CRS, The Bronx

10461

Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx

11203

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS, Brooklyn

14642

Strong Memorial Hospital Rochester NY NICHD CRS, Rochester

20010

Children's National Med. Ctr. Washington DC NICHD CRS, Washington D.C.

20060

Howard Univ. Washington DC NICHD CRS, Washington D.C.

27710

DUMC Ped. CRS, Durham

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33136

Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami

33316

South Florida CDTC Ft Lauderdale NICHD CRS, Fort Lauderdale

38105

St. Jude/UTHSC CRS, Memphis

48201

Children's Hospital of Michigan NICHD CRS, Detroit

60608

Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program, Chicago

60612

Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago

60614

Chicago Children's CRS, Chicago

70118

Children's Hosp., New Orleans

77030

Texas Children's Hosp. CRS, Houston

80045

Univ. of Colorado Denver NICHD CRS, Aurora

90806

Miller Children's Hosp. Long Beach CA NICHD CRS, Long Beach

91803

Usc La Nichd Crs, Alhambra

92103

UCSD Mother-Child-Adolescent Program CRS, San Diego

94143

Univ. of California San Francisco NICHD CRS, San Francisco

98105

Seattle Children's Hospital CRS, Seattle

90095-1752

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles

92868-3874

Children's Hosp. of Orange County, Orange

06106

Connecticut Children's Med. Ctr., Hartford

02115

Children's Hosp. of Boston NICHD CRS, Boston

02118

Boston Medical Center Ped. HIV Program NICHD CRS, Boston

01605

WNE Maternal Pediatric Adolescent AIDS CRS, Worcester

07103

Rutgers - New Jersey Medical School CRS, Newark

11794-8111

SUNY Stony Brook NICHD CRS, Stony Brook

00935

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan

00936

San Juan City Hosp. PR NICHD CRS, San Juan

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00339040 - Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children | Biotech Hunter | Biotech Hunter