Inflammatory responses to hepatitis B virus vaccine in healthy term infants

Eur J Pediatr. 2013 Jun;172(6):839-42. doi: 10.1007/s00431-013-1946-2. Epub 2013 Jan 29.


Hepatitis B virus (HBV) infection continues to be a serious global health problem. During the course of HBV vaccination, we observed C-reactive protein (CRP) elevation in term infants without sepsis. Therefore, we prospectively studied interleukin-6 (IL-6) and CRP responses to HBV immunization. In 70 healthy term infants without signs and symptoms of sepsis and sepsis risk factors, IL-6, CRP, and white blood cell count levels were determined before and 24 h after immunization. Significant increases in CRP levels were seen 24 h after vaccination (p < 0.001). Although CRP levels of 22 infants at second evaluation were above the cutoff level for sepsis (4.82 mg/L), they had no clinical signs and symptoms of sepsis. After 48-72 h, CRP levels of these infants returned to normal levels with no blood culture positivity.

Conclusion: our study showed that HBV vaccine is responsible for CRP elevation in term infants after vaccination at birth. To the best of our knowledge, this is the first study evaluating CRP response to HBV vaccine at birth in term infants. We suggest that this response should be considered in differentiation of early neonatal sepsis to avoid unnecessary antibiotic use.

Publication types

  • Clinical Trial

MeSH terms

  • Biomarkers / blood
  • C-Reactive Protein / metabolism*
  • Diagnosis, Differential
  • Female
  • Hepatitis B Vaccines / adverse effects*
  • Humans
  • Infant, Newborn
  • Inflammation / blood
  • Inflammation / diagnosis
  • Inflammation / etiology*
  • Interleukin-6 / blood*
  • Leukocyte Count
  • Male
  • Pilot Projects
  • Prospective Studies
  • Sepsis / blood
  • Sepsis / diagnosis
  • Vaccines, Synthetic / adverse effects


  • Biomarkers
  • Euvax-B
  • Hepatitis B Vaccines
  • Interleukin-6
  • Vaccines, Synthetic
  • C-Reactive Protein