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Published on: December 19, 2020
Immunogenicity and tolerance of H. influenzae type b, tetanus toxoid conjugate vaccine given concurrently or in
1Department of Pediatrics, Kalawati Saran Children's Hospital, New Delhi.
Insights
The PRP-T conjugate vaccine (ACT-HIB) demonstrated strong immunogenicity and a favorable safety profile in Indian infants and children. Both primary and booster vaccination schedules induced significant antibody responses, indicating its effectiveness in protecting against disease.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Haemophilus influenzae type b (Hib) infections pose a significant threat to infants and children.
- Conjugate vaccines, such as PRP-T (HibTITER), are crucial for preventing Hib disease.
- Evaluating vaccine immunogenicity and safety in diverse populations is essential.
Purpose of the Study:
- To assess the seroresponse and side effects of the PRP-T conjugate vaccine (ACT-HIB).
- To compare vaccine performance in infants (2 months) and older children (16-24 months).
- To evaluate different administration methods (separate vs. co-administration with DPT).
Main Methods:
- Prospective, open, controlled, randomized comparative trial.
- Two age groups: infants (2 months) and children (16-24 months).
- Subgroups received PRP-T with DPT at separate sites or mixed in one syringe.
Main Results:
- Comparable and significantly elevated Anti-PRP antibody titers post-vaccination in both age groups.
- High seroprotection rates: 96% in infants and 98% in children achieved anti-PRP levels > 1.0 mcg/ml.
- Minimal, local, and comparable side effects across study and control groups.
Conclusions:
- PRP-T conjugate vaccine (ACT-HIB) is highly immunogenic in Indian infants and children.
- The vaccine is well-tolerated, with minimal adverse effects.
- Both primary and booster vaccination schedules effectively induce protective antibody levels.
Abstract:
The present prospective, open, controlled, randomised comparative trial was undertaken to evaluate the sero response and side effects of PRP-T Conjugate Vaccine (ACT-HIB) in infants and children aged 2 months and 16-24 months. Fifty four babies aged 2 months formed group A, 56 children aged 16-24 months formed group B. Groups A and B were further subdivided into two sub groups each destined to receive either PRP-T vaccine in association with DPT vaccine at different sites (I) or PRP-T and DPT both vaccines at the same site mixed in the same syringe (II). Group A received 3 doses at 2, 3 and 4 months of age and group B received one dose between 16-24 months. The Geometric mean titres of Anti PRP antibodies observed in primary immunisation schedule (A) and single dose vaccination schedule (B) were comparable and significantly higher to prevaccination titres. A serum anti PRP level of > 1.0 mcg/ml after immunisation is believed to correlate with long term protection. Ninety-six percent of infants in Group A and 98% in Group B achieved titres > 1.0 mcg/ml. The side effects were minimal, local and were comparable between the study and control groups, suggesting that PRP-T vaccine is highly immunogenic and well tolerated in Indian infants and children.
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