Safety and immunogenicity of three doses of a five-valent pneumococcal conjugate vaccine in children younger than two years with and without human immunodeficiency virus infection.

Abstract

OBJECTIVE:

To assess the safety and immunogenicity of three doses of a five-valent (types 6B, 23F, 14, 18C, and 19F) pneumococcal conjugate vaccine (PCV) among children younger than 2 years who are and are not infected with human immunodeficiency virus (HIV).

METHODS:

A convenience sample of 18 HIV-infected children 2 years and younger (mean, 12.9 months) received three doses (each separated by 2 months) of PCV. An additional convenience sample of 33 non-HIV-infected children of virtually identical age, race, and sex as the HIV-infected group were randomized in a double-blind fashion to receive three doses of PCV or saline placebo. Safety data were collected for 72 hours after each vaccination. Sera were obtained before each and 1 month after the third vaccination to determine vaccine type-specific immunoglobulin G pneumococcal antibody titers by an enzyme-linked immunosorbent assay.

RESULTS:

Seventeen HIV- and 30 non-HIV-infected children completed the study. The PCV was well tolerated by both HIV- and non-HIV-infected children. No significant differences in local or systemic reactions were noted between HIV- and non-HIV-infected PCV or placebo recipients. Three doses of PCV were immunogenic, as evidenced by 16- to 659-fold increases in type-specific geometric mean antibody titers over prevaccination levels in HIV- and non-HIV-infected children. With respect to an arbitrary protective level, 78% of the antibody titers from HIV-infected children and 88% of the titers from non-HIV-infected children were 1.0 microgram/mL or greater 1 month after the third PCV dose. HIV-infected children with milder disease (Centers for Disease Control and Prevention classes N1-2, A1-2, and B1) were more likely to have protective antibody titers after the first and second PCV doses than HIV-infected children with more advanced disease (Centers for Disease Control and Prevention classes N3, A3, B2-3, and C1-3). However, after the third PCV dose, these differences disappeared.

CONCLUSION:

Three doses of PCV seem safe and immunogenic in both HIV- and non-HIV-infected children younger than 2 years. This type of vaccine should result in a marked reduction in systemic pneumococcal disease in both HIV- and non-HIV-infected children. Given the high incidence of invasive pneumococcal disease in HIV-infected children, this vaccine may markedly improve the quality of life for this unfortunate group of children.

• Authors: J C King Jr, P E Vink, J J Farley, M Smilie, M Parks, R Lichenstein
• Journal: Pediatrics (Pediatrics) Vol. 99 Issue 4 Pg. 575-80 (Apr 1997) ISSN: 1098-4275 [Electronic] United States
• PMID: 9093301 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Bacterial Vaccines
• Pneumococcal Vaccines
• Vaccines, Conjugate
• five-valent pneumococcal conjugate vaccine

Topics

• AIDS-Related Opportunistic Infections (immunology)
• Bacterial Vaccines (adverse effects, immunology)
• HIV Infections (immunology)
• Humans
• Infant
• Pneumococcal Infections (immunology)
• Pneumococcal Vaccines
• Vaccines, Conjugate (adverse effects, immunology)