The immunogenicity and safety of pneumococcal conjugate vaccine in human immunodeficiency virus-infected Thai children

Abstract

Background HIV-infected children have high risk of invasive pneumococcal disease (IPD) despite receiving highly active antiretroviral therapy (HAART). This study aimed to determine the immunogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV-7) in Thai HIV-infected children compared to HIV-exposed uninfected children. Methods A prospective study was conducted among children 2 months to 9 years. The number of PCV-7 doses depended upon age and HIV status; 2–6 months of age: 3 doses; 7–23 months of age: 2 doses; HIV-infected child ≥24 months: 2 doses and HIV-exposed child ≥24 months: 1 dose. Serotype-specific pneumococcal IgG antibody concentrations were measured at baseline and 28 days after complete vaccination. The primary end point was the proportion of children who achieved serotype-specific IgG antibody concentration at a cut off level ≥0.35 μg/mL. Secondary end points were a 4-fold increase in serotype-specific IgG antibody, rates of adverse events and predictors for seroconversion among HIV-infected children. Results Fifty-nine HIV-infected and 30 HIV-exposed children were enrolled. The median (IQR) age was 97 (67–111) and 61 months (51–73), respectively ( p < 0.001). Among HIV-infected children, current and nadir CD4 counts were 1079 cell/mm 3 and 461 cell/mm 3, respectively. The proportion of children who achieved pneumococcal IgG ≥0.35 μg/mL was in the range of 85–98% in HIV-infected and 83–100% in HIV-exposed children depending on serotype. The lowest response was to serotype 6B in both groups. The 4-fold increase in serotype-specific IgG concentrations was similar between HIV-infected and HIV-exposed groups, except for serotype 9V ( p = 0.027). HIV-infected children who had a history of AIDS had a lower antibody response to serotype 23F ( p = 0.025). Seven (12%) HIV-infected children had a grade 3 local reaction. Conclusion PCV-7 is highly immunogenic and safe among HIV-infected children treated with HAART. The use of the pneumococcal conjugate vaccine among HIV-infected children is encouraged in order to prevent IPD.