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.
RCT Entities:
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-infectedchildren 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-infectedchildren 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-infectedchildren completed the study. The PCV was well tolerated by both HIV- and non-HIV-infectedchildren. 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-infectedchildren. With respect to an arbitrary protective level, 78% of the antibody titers from HIV-infectedchildren and 88% of the titers from non-HIV-infectedchildren were 1.0 microgram/mL or greater 1 month after the third PCV dose. HIV-infectedchildren 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-infectedchildren 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-infectedchildren younger than 2 years. This type of vaccine should result in a marked reduction in systemic pneumococcal disease in both HIV- and non-HIV-infectedchildren. Given the high incidence of invasive pneumococcal disease in HIV-infectedchildren, this vaccine may markedly improve the quality of life for this unfortunate group of children.
Authors: Sally A Quataert; Kate Rittenhouse-Olson; Carol S Kirch; Branda Hu; Shelley Secor; Nancy Strong; Dace V Madore Journal: Clin Diagn Lab Immunol Date: 2004-11
Authors: Shabir A Madhi; Peter Adrian; Mark F Cotton; James A McIntyre; Patrick Jean-Philippe; Shawn Meadows; Sharon Nachman; Helena Käyhty; Keith P Klugman; Avye Violari Journal: J Infect Dis Date: 2010-08-15 Impact factor: 5.226