A Phase 1 interventional study of Pneumococcal Vaccine, Polyvalent (23-valent) and Pneumococcal Conjugate Vaccine, Heptavalent in HIV Infections and Pneumococcal Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 33 sites in 2 countries. Open to participants aged 2 Months to 6 Months. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
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:
Prior Treatment:
Excluded:
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
Biological: Pneumococcal Vaccine, Polyvalent (23-valent) · Biological: Pneumococcal Conjugate Vaccine, Heptavalent
Patients receiving placebo vaccine
Biological: Pneumococcal Vaccine, Polyvalent (23-valent) · Biological: Placebo
Administered as an injection at 24 months of age
Administered as an injection at 0, 2, 4, and 15 months of age
Administered at 0, 2, 4, and 15 months of age
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
Time frame: Throughout study
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
Time frame: Throughout study
Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo
Time frame: Prior to 4th vaccination and at 1 month after 4th vaccination
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients
Time frame: Throughout study
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients
Time frame: At a time after the 3rd vaccination and at a time after the 4th vaccination
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters
Time frame: Throughout study
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)