Search / Trial NCT00000829

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

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Vaccines, Synthetic Acquired Immunodeficiency Syndrome Aids Related Complex Pneumococcal Infections Bacterial Vaccines

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. 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.

Attachments

readout_NCT00000829_2024-04-22.pdf

4.5 MB

NCT00000829_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Oakland, California, United States

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

New York, New York, United States

San Francisco, California, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

New Brunswick, New Jersey, United States

Bronx, New York, United States

Great Neck, New York, United States

New York, New York, United States

New York, New York, United States

Durham, North Carolina, United States

Houston, Texas, United States

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Los Angeles, California, United States

Jacksonville, Florida, United States

Chicago, Illinois, United States

Detroit, Michigan, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Throughout study

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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