Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Pneumococcal Vaccine, Polyvalent (23-valent)

+ Pneumococcal Conjugate Vaccine, Heptavalent

+ Placebo

Biological
Who is being recruted

Blood-Borne Infections+19

+ Urogenital Diseases

+ Genital Diseases

From 2 to 6 Months
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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 either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.

Official TitleA Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
NCT00000829
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 6 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPneumococcal InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesStreptococcal InfectionsVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsGram-Positive Bacterial Infections

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine

Group II

Placebo
Patients receiving placebo vaccine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 33 locations

Suspended

Usc La Nichd Crs

Los Angeles, United StatesOpen Usc La Nichd Crs in Google Maps
Suspended

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, United States
Suspended

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, United States
Suspended

San Francisco Gen. Hosp.

San Francisco, United States
Completed33 Study Centers