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Influenza A Virus Studies in a Mouse Model of Infection
Published on: September 7, 2017
Immunogenicity and safety of live attenuated hepatitis A vaccine: a multicentric study
M M A Faridi1, Nitin Shah, T K Ghosh
1Department of Pediatrics, University College of Medical Sciences, New Delhi.
Insights
A single dose of live attenuated injectable hepatitis A vaccine demonstrated strong immunogenicity and good tolerability in Indian children. The vaccine proved safe and effective, with high seroconversion rates and minimal adverse events observed.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Hepatitis A remains a public health concern, necessitating effective vaccination strategies.
- Live attenuated vaccines offer a promising approach for infectious disease prevention.
Purpose of the Study:
- To assess the immunogenicity and tolerability of a single-dose live attenuated injectable hepatitis A vaccine.
- To evaluate the vaccine's safety profile in a pediatric population across four Indian metropolitan cities.
Main Methods:
- 505 children aged 18-60 months received a single dose of the live attenuated hepatitis A vaccine.
- Anti-HAV antibody titers were measured at 6 weeks and 6 months post-vaccination.
- Safety and adverse events were monitored throughout the study period.
Main Results:
- High seroconversion rates were observed: 95.1% at 6 weeks and 97.9% at 6 months.
- Geometric Mean Titer (GMT) increased significantly from 81.04 mIU/ml at 6 weeks to 150.66 mIU/ml at 6 months.
- The vaccine was well-tolerated, with only minor, infrequent adverse events like swelling and induration.
Conclusions:
- The single-dose live attenuated injectable hepatitis A vaccine is immunogenic and tolerable in children.
- The vaccine exhibits a satisfactory safety profile with minimal reactogenicity.
- This study supports the use of this vaccine in a single-dose schedule for hepatitis A prevention.
Objective:
To evaluate immunogenicity and tolerability of single dose live attenuated injectable hepatitis A vaccine in four metropolitan cities of India.
Methods:
Live attenuated hepatitis A vaccine was administered to 505 children aged 18 to 60 months in four centers across India. Immunogenicity of the vaccine was assessed by estimation of anti-HAV antibody titer at 6 weeks and 6 months following administration of the vaccine. Safety evaluation of the vaccine was also done during the visits.
Results:
At 6 weeks, 480 subjects (95%) came for the follow-up and 411 (81.4%) subjects reported at the end of 6 months. The geometric mean titer (GMT) of anti-HAV antibody of the subjects who did not have the seroprotective titer at the baseline were assessed at 6 weeks and 6 months which was 81.04 mIU/ml and 150.66 mIU/ml respectively. At 6 weeks, 95.1 % seroconverted and at the end of 6 months, 97.9 % had seroconverted. Both solicited and unsolicited vaccine-induced local and systemic adverse events were insignificant at all the centers, except swelling and induration in a few.
Conclusion:
Live attenuated injectable hepatitis A vaccine was immunogenic and tolerable with minimal reactogenecity, in this study of single dose schedule. Safety profile was also satisfactory in the study population.
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