Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib vaccine as primary and booster vaccination in low-birth-weight premature infants.
OBJECTIVE
To assess suitability of a combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) for immunization of low-birth-weight (<2.0 kg) preterm infants, with particular focus on the hepatitis B response.


METHODS
Open-label study in 170 preterm infants receiving primary vaccination at 2, 4 and 6 months of age and booster vaccination at 18-24 months. Enrollment and analysis were stratified in two groups: infants with birth weight between 1.5 kg and 2.0 kg (low birth weight: LBW), infants with BW <1.5 kg (very low birth weight: VLBW).


RESULTS
One month after the three dose primary vaccination, 93.7% and 94.9% of infants in VLBW and LBW groups, respectively, had anti-HBs antibody concentrations > or = 10 mIU/mL. High seroprotection and response rates (92.4-100%) to all vaccine antigens were observed. Those were reinforced (>98%) by booster vaccination for all antigens except for HBs in VLBW children: only 88.7% of those had anti-HBs antibody concentrations > or = 10 mIU/mL, compared with 96.5% of LBW children (difference statistically not significant). The vaccine was well tolerated in both groups of infants.


CONCLUSIONS
Preterm infants will benefit by the administration of a primary and booster vaccination with DTPa-HBV-IPV/Hib vaccine.
Vázquez
Liliana
L
Fundación Centro de Estudios Infectológicos, Buenos Aires, Argentina.
Garcia
Fabiana
F
Rüttimann
Ricardo
R
Coconier
Gustavo
G
Jacquet
Jeanne-Marie
JM
Schuerman
Lode
L
D000704:Analysis of Variance; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D007230:Infant, Low Birth Weight / Q000276:immunology*; D007231:Infant, Newborn; D007234:Infant, Premature / Q000276:immunology*; D008297:Male; D012698:Serologic Tests
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; C122182:diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine