NCT00000829

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Not accepted

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 assess whether this vaccine is more immunogenic than placebo following the third vaccination. 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.

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. 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.

Conditions

• HIV Infections
• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal Vaccine, Polyvalent (23-valent)	Administered as an injection at 24 months of age
BIOLOGICAL	Pneumococcal Conjugate Vaccine, Heptavalent	Administered as an injection at 0, 2, 4, and 15 months of age
BIOLOGICAL	Placebo	Administered at 0, 2, 4, and 15 months of age

Timeline

• Completion: 1999-10-01
• First posted: 2001-08-31
• Last updated: 2021-10-28

Locations

33 sites across 2 countries: United States, Puerto Rico