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Evaluation of immunogenicity and tolerance of single dose haemophilus influenzae type B (PRP-T) vaccine
D Acharya1, A Desai, N Nanavaty
1Department of Pediatrics, King Edward Memorial Hospital, Pune.
Insights
The PRP-T vaccine demonstrated strong immunogenicity and good tolerance in Indian children, with no significant impact on immunogenicity when combined with the DPT vaccine.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Haemophilus influenzae type B (Hib) infections pose a significant public health concern, particularly in regions with high rates of subclinical infection or cross-immunity.
- Evaluating vaccine efficacy and safety in diverse populations is crucial for global health initiatives.
Purpose of the Study:
- To assess the immunogenicity and acceptability of the PRP-T vaccine in Indian children.
- To compare the immunogenicity of Hib vaccine when administered alone versus in combination with the DPT vaccine.
Main Methods:
- A multicentric, open-label, parallel-group comparative study.
- Involved 125 children aged 18-24 months across five vaccination clinics.
- Measured pre- and post-vaccination antibody titers, adverse events, and physician-graded tolerance.
Main Results:
- High prevaccination antibody levels suggest potential prior exposure or cross-immunity in the study population.
- Excellent post-seroconversion rates were observed for the Hib vaccine (PRP-T), with 97% in the single-dose group and 100% in the combination DPT group.
- The PRP-T vaccine was well-tolerated, with no significant difference in immunogenicity when co-administered with DPT.
Conclusions:
- The ACTHIB (PRP-T) vaccine exhibits robust immunogenicity and favorable safety profile in Indian children.
- Co-administration of ACTHIB with DPT does not compromise the immunogenicity of the Hib vaccine.
- Findings support the high probability of subclinical Hib infection or cross-immunity in India, underscoring the need for effective vaccination strategies.
Objective:
Evaluation of immunogenicity and acceptability of PRP-T vaccine among the Indian children.
Design:
Multicentric, open, parallel group, comparative study of Haemophilus influenzae type B vaccine, given as single (Group I) or associated (Group II) with DPT vaccine.
Setting:
Five different vaccination clinics.
Subjects:
125 children between the age group of 18-24 months.
Parameters:
Measurement of (i) pre and post vaccination antibody titres of Haemophilus influenze type B specific antibody; (ii) Adverse events; and (iii) Tolerance as graded by the physician.
Results:
Prevaccination antibody levels were > 0.15 mcg/ml in 56.3% in Group I and 35.7% in Group II. Post-seroconversion was seen in 97% in Group II receiving single and all in Group II (P > 0.05). The vaccine was well tolerated.
Conclusions:
The probability of subclinical infection or cross immunity is high in India. ACTHIB vaccine has a good immunogenicity and tolerance and association with DPT does not modify the immunogenicity of ACTHIB vaccine.