Immunogenicity and safety of primary three-dose series with diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed in 3 months infants - Summary - MDSpire
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Immunogenicity and safety of primary three-dose series with diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed in 3 months infants
To evaluate the safety and immunogenicity of a diphtheria, tetanus, and pertussis (acellular, three components) combined vaccine (DTcP) compared to existing vaccines in China.
Approach:
Study Design: A partially randomized, blinded, controlled Phase III trial involving 1,140 infants receiving a 3-dose primary series at 3, 4, and 5 months.
Vaccines Compared: DTcP vaccine was compared against licensed co-purified DTaP and DTaP-IPV-Hib vaccines.
Key Findings:
DTcP and co-purified DTaP had lower incidences of overall adverse reactions compared to DTaP-IPV-Hib (17.99%/18.08% vs. 21.96%).
DTcP demonstrated non-inferiority and superiority over co-purified DTaP for anti-PT and anti-FHA immunogenicity.
DTcP achieved a 98.16% seroconversion rate for anti-FHA, compared to 14.29% for co-purified DTaP.
Anti-PT GMC was significantly higher in the DTcP group (85.10) compared to DTaP (49.86) and DTaP-IPV-Hib (74.25).
Anti-FHA GMC was also significantly higher in the DTcP group (108.28) compared to DTaP (10.69).
Interpretation:
DTcP vaccine induces a more robust immune response to key pertussis antigens compared to co-purified DTaP, with a comparable safety profile.
Limitations:
The study was conducted in a single province in China, which may limit generalizability.
Long-term follow-up data on immunity and safety were not provided.
Conclusion:
The findings support the optimization of China's immunization strategy by transitioning to component-based acellular pertussis vaccines.
