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Immunogenicity study of Haemophilus influenzae type B conjugate vaccine in Indian infants
M A Phadke1, M V Kulkarni, V B Sovani
1Department of Pediatrics, B.J. Medical College, Pune.
Insights
The Haemophilus influenzae type b oligosaccharide conjugate vaccine (HbOC) is immunogenic in Indian infants. This study shows it elicits a protective antibody response when administered with routine immunizations.
Area of Science:
- Pediatric immunology
- Vaccine development
- Infectious disease prevention
Background:
- Haemophilus influenzae type b (Hib) is a significant cause of bacterial meningitis and other invasive diseases in young children.
- Effective conjugate vaccines are crucial for preventing Hib infections, especially in regions with high disease burden.
- Assessing the immunogenicity of specific Hib vaccines in diverse populations is essential for public health strategies.
Purpose of the Study:
- To evaluate the immunogenicity of the Haemophilus influenzae type b oligosaccharide conjugate vaccine (HbOC) in Indian infants.
- To determine if HbOC elicits a protective antibody response according to established immunological benchmarks.
Main Methods:
- A prospective, multicenter study was conducted in pediatric outpatient departments in Pune and Mumbai, India.
- 124 healthy, full-term infants received three doses of HbOC intramuscularly, coinciding with their DPT/OPV immunizations.
- Anti-polyribosil ribitol phosphate (PRP) antibody titers were measured before the first dose and one month after the third dose.
Main Results:
- The geometric mean titers (GMT) of anti-PRP antibodies increased 37-fold, from 0.124 mcg/ml to 4.552 mcg/ml.
- 95.1% of infants achieved a final antibody titer of ≥0.15 mcg/ml, indicating protection.
- 74.8% of infants reached a titer of ≥1.0 mcg/ml, suggesting long-term protection.
Conclusions:
- The HbOC vaccine demonstrates significant immunogenicity in Indian infants.
- The vaccine is well-tolerated and effective when administered according to the recommended DPT/OPV immunization schedule.
- These findings support the use of HbOC for Hib prevention in the Indian pediatric population.
Objective:
To assess the immunogenicity in Indian infants to Haemophilus influenzae b oligosaccharide conjugate vaccine (HbOC).
Design:
Prospective multicenter study.
Setting:
Pediatric Out Patient Department of general hospitals in Pune and Mumbai.
Subjects:
124 full term healthy infants brought for routine DPT/OPV immunization.
Methods:
Infants were administered 3 doses of 0.5 ml of HbOC, on the same day as their DPT/OPV immunization, injected intramuscularly on the limb opposite to that where DPT vaccine was administered. Data on local reactions and general symptoms was collected for three days after every dose. The children had their blood collected for assay of anti PRP (polyribosil ribitol phosphate) antibody titers, along with the first injection and one month after the third injection. One hundred and three infants completed the study protocol with two blood collections.
Results:
The initial geometric mean titers (GMT) of 0.124 mcg/ml rose by 37 times to 4.552 mcg/ml. Ninety eight children (95.1%) had a final titer of > or = 0.15 mcg/ml, the minimum level associated with protection, and 77 children (74.8%) had a final level of > or = 1.0 mcg/ml, a level associated with long term protection.
Conclusion:
HbOC is immunogenic in Indian infants when used as per the locally recommended DPT/OPV immunization schedule.