A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants - Article
Clinical Trial: A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
This study is no longer recruiting patients.
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
|Condition||Treatment or Intervention||Phase|
|HIV Infections |
| Vaccine: Pneumococcal Vaccine, Polyvalent (23-valent) |
Vaccine: Pneumococcal Conjugate Vaccine, Heptavalent
|Phase I |
MedlinePlus related topics: AIDS; Streptococcal Infections; Throat Disorders
Study Type: Interventional
Study Design: Prevention, Double-Blind
Expected Total Enrollment: 60
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.
Ages Eligible for Study: 2 Months - 6 Months, Genders Eligible for Study: Both
Concurrent Medication: Allowed:
- Antipyretics for rectal temperature >= 100.4 F.
- Antiretroviral therapy.
Patients must have:
- HIV positivity.
- Birth weight at least 1800 g (3.75 lb).
- Consent and compliance of parent or guardian.
- Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.
Co-existing Condition: Patients with the following symptoms or conditions are excluded:
- Enrollment in HIV vaccine trials.
- Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.
- Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.
Concurrent Medication: Excluded:
- Prophylactic antipyretics.
Patients with the following prior conditions are excluded: Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry.
Prior Medication: Excluded:
- Any prior pneumococcal vaccine.
- Measles vaccine within 1 month prior to study vaccination.
- Any other routine vaccine within 1 week prior to study vaccination.
- Any immunosuppressant agent, including prednisone, for more than 6 weeks.
Prior Treatment: Excluded:
- Blood products within 56 days prior to study vaccination.
UCSF / Moffitt Hosp - Pediatric, San Francisco, California, 941430105, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California, 920930672, United States
San Francisco Gen Hosp, San Francisco, California, 94110, United States
Children's Hosp of Oakland, Oakland, California, 946091809, United States
Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States
Univ of Miami (Pediatric), Miami, Florida, 33161, United States
Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida, 32209, United States
Emory Univ Hosp / Pediatrics, Atlanta, Georgia, 30306, United States
Chicago Children's Memorial Hosp, Chicago, Illinois, 606143394, United States
Cook County Hosp, Chicago, Illinois, 60612, United States
Univ of Chicago Children's Hosp, Chicago, Illinois, 606371470, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp - Pediatric, Baltimore, Maryland, 212874933, United States
Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States
Children's Hosp of Michigan, Detroit, Michigan, 48201, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey, 089030019, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark, New Jersey, 071072198, United States
Harlem Hosp Ctr, New York, New York, 10037, United States
Cornell Univ Med College, New York, New York, 10021, United States
North Shore Univ Hosp, Great Neck, New York, 11021, United States
Nassau County Med Ctr, East Meadow, New York, 11554, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States
Columbia Presbyterian Med Ctr, New York, New York, 10032, United States
Mount Sinai Med Ctr / Pediatrics, New York, New York, 10029, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr, Bronx, New York, 10457, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York, 10032, United States
State Univ of New York at Stony Brook, Stony Brook, New York, 117948111, United States
Univ of Rochester Med Ctr, Rochester, New York, 146420001, United States
Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States
Columbus Children's Hosp, Columbus, Ohio, 432052696, United States
Children's Hosp of Philadelphia, Philadelphia, Pennsylvania, 191044318, United States
Texas Children's Hosp / Baylor Univ, Houston, Texas, 77030, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, 009365067, Puerto Rico
King J, Study Chair
Nachman S, Study Chair
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000829
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Vancomycin-Intermediate/Resistant Staphylococcus aureus(VISA/VRSA) Infections (Centers for Disease Control and Prevention)