A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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...

Gender

ALL

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.