Related Experiment Videos
Hepatitis B vaccination in premature and low birth weight (LBW) babies
Sheila Bhave1, Snehalata Bhise, Sanjay C Chavan
1Department of Pediatrics, KEM Hospital, Pune 411 011, India.
Insights
Preterm and low birth weight babies (LBW) showed a strong immune response to the hepatitis B (HB) vaccine. High seroprotective levels were achieved early, demonstrating the vaccine
Area of Science:
- Immunology
- Pediatrics
- Vaccinology
Background:
- Hepatitis B (HB) infection poses a significant risk to newborns, especially preterm and low birth weight (LBW) infants.
- Assessing the immunogenicity of new-generation vaccines in vulnerable infant populations is crucial for public health strategies.
Purpose of the Study:
- To evaluate the immune response and safety of a recombinant DNA hepatitis B (HB) vaccine in preterm, LBW, and full-term infants.
- To compare the seroconversion rates and antibody titers among different infant groups receiving the HB vaccine.
Main Methods:
- An open trial involving 100 infants divided into four groups: preterm (<34 weeks GA), late preterm (34-36 weeks GA), LBW (<2.5 kg), and controls (>2.5 kg).
- Infants received a recombinant DNA HB vaccine on a 0, 1, 2, and 12-month schedule, with immune response assessed by anti-HBs titers.
- Adverse events were monitored throughout the study.
Main Results:
- 100% seroconversion was observed after the second dose of the HB vaccine across all groups.
- High anti-HBs titers (>1000 mIU/ml in 85%) were recorded by one year, indicating long-term seroprotection.
- The vaccine was well-tolerated with no reported adverse reactions in any study group.
Conclusions:
- The recombinant DNA HB vaccine elicits a uniformly good immune response in preterm, LBW, and full-term infants.
- Early achievement of high and sustained seroprotective antibody levels suggests effective protection against hepatitis B in all infant populations studied.
Objective:
To assess the immune response of preterm and low birth weight babies (LBW) to hepatitis B (HB) vaccine.
Setting:
Neonatal Intensive Care Unit (NICU), postnatal ward and follow up clinics of KEM Hospital, Pune.
Design:
Open trial.
Methods:
100 babies were enrolled in four study groups. Group I - preterm, gestational age (GA) < 34 weeks; Group II - GA 34 to 36 weeks; Group III full term <2.5 kg (LBW babies); and Group IV full term >2.5 kg (controls). A recombinant DNA HB vaccine was given at 0, 1, 2 and 12 month schedule. The first injection was administered as soon as the neonate was stabilized. Immune response in terms of anti HBs titres (AUSAB EIA Diagnostic kit) was measured one month after each of the first three injections and at the time of one year booster. Adverse events were monitored.
Results:
88 and 62 babies completed the study till the third dose and one year booster dose respectively. Immune response of HB vaccine was uniformly good in all the study groups with 100 % sero-conversion after the second dose itself. By one year (i.e. before the booster dose), very high titres were recorded in all 100%, with 85% demonstrating titres >1000 mIU/ml. Preterm and LBW babies had higher GMT as compared to full term babies till one month after third dose. By one year (before booster), full term babies had higher GMT than preterm and LBW babies. However, these differences were not statistically significant. The vaccine was well tolerated and safe and there were no adverse reactions.
Conclusion:
Immune response of preterm, LBW and full term babies to the new generation recombinant DNA HB vaccine was uniformly good. High and long term seroprotective levels were achieved after the second dose itself.