title: 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 1,079 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.
  
  
  CONCLUSIONS
  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.
authors: Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
authors: Chareeya
authors: C
authors: Thanee
authors: Chitsanu
authors: C
authors: Pancharoen
authors: Sasithorn
authors: S
authors: Likitnukul
authors: Voravich
authors: V
authors: Luangwedchakarn
authors: Pinklow
authors: P
authors: Umrod
authors: Chayapa
authors: C
authors: Phasomsap
authors: Tanakorn
authors: T
authors: Apornpong
authors: Thongsuai
authors: T
authors: Chuanchareon
authors: Oratai
authors: O
authors: Butterworth
authors: Thanyawee
authors: T
authors: Puthanakit
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D000907:Antibodies, Bacterial / Q000097:blood*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D002675:Child, Preschool; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D011008:Pneumococcal Infections / Q000453:epidemiology / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology / Q000627:therapeutic use; D011446:Prospective Studies; D013296:Streptococcus pneumoniae / Q000145:classification / Q000276:immunology*; D013785:Thailand; D016896:Treatment Outcome; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology / Q000627:therapeutic use
chemical_list: D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate