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

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety