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

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed
Phase 1

Conditions

HIV Infections
Pneumococcal Infections

Treatments

Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
Biological: Placebo
Biological: Pneumococcal Conjugate Vaccine, Heptavalent

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT00000829
ACTG 292
11268 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 6 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
Treatment:
Biological: Pneumococcal Conjugate Vaccine, Heptavalent
Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
2
Placebo Comparator group
Description:
Patients receiving placebo vaccine
Treatment:
Biological: Placebo
Biological: Pneumococcal Vaccine, Polyvalent (23-valent)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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