Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
- 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)Other: Placebo/QHPV
- Registration Number
- NCT00339040
- Brief Summary
The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.
- Detailed Description
Genital HPV infection is the most common sexually transmitted infection in the world and may lead to genital warts, anogenital dysplasias, and invasive cancers. HIV infected people and others with compromised immunity are at greater risk for HPV-related complications. In particular, researchers are concerned about the risk of HPV infection to women, who may be infected by their male partners, especially if these partners engage in anal intercourse. HIV infected women tend to have multiple types of HPV (associated with a greater risk of HPV-related disease), are less likely to clear HPV-related conditions, and are more likely to progress to HPV-related disease. The quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine to be tested in this study was safe and generally well tolerated in previous studies conducted in healthy and HPV-exposed adolescents, young adults, and older women. However, it is still unclear if the vaccine will be safe and will elicit a similar immune response in younger children. The purpose of this study is to evaluate the safety and immunogenicity of the novel quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine in HIV infected children 7 to 12 years of age.
This study had two stages and lasted at least 108 weeks. In Stage I, participants were stratified by CD4 percentage (CD4%) nadir and CD4% at study screening (Stratum A: CD4% Nadir \< 15 and CD4% ≥ 15 at screening, Stratum B: CD4% Nadir ≥ 15 and \< 25 and CD4% ≥ 15 at screening, Stratum C: CD4% Nadir ≥ 25 and CD4% ≥ 25 at screening). Within each stratification group, they were randomly assigned to one of two arms. During Stage I, Arm A (QHPV:Quadrivalent human papillomavirus vaccine) participants received 3 doses of vaccine, while Arm B (Placebo/QHPV) participants received 3 doses of placebo. Participants did not know whether they were receiving vaccine or placebo. Participants received their assigned intervention at study entry and Weeks 8 and 24. At Week 96, Stage II began, and all study participants were told if they received vaccine or placebo in Stage I. Arm A participants received an additional dose of vaccine at Week 96; Arm B participants received doses of vaccine at Weeks 96, 104, and 120. Over the course of the study, there were at least 12 study visits. A physical exam and blood collection occurred at most visits; medical history occurred at selected visits.
After each vaccination, participants were observed for at least 30 minutes to monitor for any allergic reactions possibly resulting from the vaccination. For 15 days following vaccination, parents or guardians were asked to complete a "report card" with details of each child's signs and symptoms. Three days after each vaccination, parents or guardians of study participants were contacted by telephone and asked about any adverse events that a child may have experienced.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: QHPV 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, 96. Arm B: Placebo/QHPV Placebo/QHPV Placebo at week 0, 8, 24; QHPV at week 96, 104, 120.
- Primary Outcome Measures
Name Time Method Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Within 14 days of first three doses of vaccination Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1="Mild", Grade 2="Moderate", Grade 3="Severe", Grade 4="Potentially Life-Threatening". All grade 3 and higher signs, symptoms, and laboratory toxicities were included.
Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment Within 14 days of first three doses of vaccination Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, "Treatment related", "Non-treatment related", "Baseline", "Possibly treatment related".
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion At week 28 after beginning the vaccination series Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units \[mMU\]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.
Serum Anti-HPV Antibody Titers (cLIA) Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124. Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)
- Secondary Outcome Measures
Name Time Method HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124. CD4 Count Over Time Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124. CD4 Percent Over Time Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
Trial Locations
- Locations (34)
St. Jude/UTHSC CRS
🇺🇸Memphis, Tennessee, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Rush Univ. Cook County Hosp. Chicago NICHD CRS
🇺🇸Chicago, Illinois, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Children's Hosp. of Boston NICHD CRS
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSD Mother-Child-Adolescent Program CRS
🇺🇸San Diego, California, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
Univ. of California San Francisco NICHD CRS
🇺🇸San Francisco, California, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Miller Children's Hosp. Long Beach CA NICHD CRS
🇺🇸Long Beach, California, United States
Usc La Nichd Crs
🇺🇸Alhambra, California, United States
Children's Hosp. of Orange County
🇺🇸Orange, California, United States
Connecticut Children's Med. Ctr.
🇺🇸Hartford, Connecticut, United States
Children's National Med. Ctr. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸Washington, District of Columbia, United States
South Florida CDTC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
🇺🇸Chicago, Illinois, United States
Boston Medical Center Ped. HIV Program NICHD CRS
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
🇺🇸Detroit, Michigan, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
Rutgers - New Jersey Medical School CRS
🇺🇸Newark, New Jersey, United States
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States
Nyu Ny Nichd Crs
🇺🇸New York, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
Seattle Children's Hospital CRS
🇺🇸Seattle, Washington, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
Children's Hosp.
🇺🇸New Orleans, Louisiana, United States
Bronx-Lebanon CRS
🇺🇸Bronx, New York, United States
Jacobi Med. Ctr. Bronx NICHD CRS
🇺🇸Bronx, New York, United States