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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Page 1 of 9 (33 locations)

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