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[Study on safety and immunogenicity of oral poliomyelitis attenuated live vaccine (human diploid cell)]
Shao-Hong Guo1, Hong Tao, Zhi-fang Ying
1Beijing Tiantan Biological Products Co., Ltd., Beijing 100024, China.
Insights
The Poliomyelitis vaccine (Human Diploid Cell) is safe and effective for children aged 2 months and older. This study demonstrates high immune response rates, confirming its immunogenicity in young children.
Area of Science:
- Vaccinology
- Immunology
- Pediatrics
Context:
- Poliomyelitis remains a global health concern, necessitating effective vaccination strategies.
- The human diploid cell (HDC) origin poliomyelitis vaccine (OPV) offers a potential alternative for polio prevention.
- Evaluating vaccine safety and immunogenicity in target populations is crucial for public health.
Purpose:
- To assess the safety and immunogenicity of the poliomyelitis vaccine (Human Diploid Cell) in children aged two months and older.
- To determine the immune response and identify any adverse events associated with the OPV (HDC) vaccine.
Summary:
- A randomized, blind, and controlled trial involving 1200 healthy children (2-5 months old) in Jiangsu province evaluated the OPV (HDC) vaccine against control vaccines.
- Following three doses, the OPV (HDC) vaccine demonstrated mild systemic reactions.
- Immune success rates for poliovirus types I, II, and III were high (98.28%, 99.45%, 95.71%), with significant geometric mean titers (GMTs) observed in susceptible children.
Impact:
- The findings support the safety and immunogenicity of the OPV (HDC) vaccine for infants and young children.
- This vaccine represents a potentially valuable tool in global poliomyelitis eradication efforts.
- The study provides robust data for public health policy regarding polio vaccination.
Objective:
To evaluate the safety and Immunogenicity of the Poliomyelitis vaccine (Human Diploid Cell) in > or =2 month-old children.
Methods:
A random, blind and control trial, 1200 healthy children of 2-5 months old in Jiangsu province were administered OPV (HDC) vaccine and control vaccines. The antibody was tested by neutralization test.
Results:
After 3 doses of the OPV (HDC) vaccine, the systemic reactions were mild. After 1 month of vaccination with 3 doses of the OPV (HDC) vaccine, the immune success rates of I, II, III type were 98.28%, 99.45%, and 95.71% respectively, the GMTs of I, II, III type in susceptible children were 1:1243.72, 1:234.38 and 1:273.10 respectively.
Conclusions:
The OPV (HDC) vaccine was safe and immunogenicity for the children > or =2 months old.
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