Status:
COMPLETED
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Lederle-Praxis Biologicals
Conditions:
HIV Infections
Pneumococcal Infections
Eligibility:
All Genders
2-6 years
Phase:
PHASE1
Brief Summary
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 asse...
Detailed Description
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. T...
Eligibility Criteria
Inclusion Criteria
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.
NOTE:
- Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.
Exclusion Criteria
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.
- Hypogammaglobulinemia.
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1999
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00000829
End Date
October 1 1999
Last Update
October 28 2021
Active Locations (33)
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1
Usc La Nichd Crs
Los Angeles, California, United States, 90033
2
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 946091809
3
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 920930672
4
San Francisco Gen. Hosp.
San Francisco, California, United States, 94110