Immunogenicity and safety of primary three-dose series with diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed in 3 months infants
In brief
Component-based DTcP vaccine yields 98% FHA seroconversion versus 14% with standard DTaP
In a phase III trial of 1,140 three-month-old infants receiving three doses, the DTcP vaccine showed safety comparable to existing DTaP products and fewer overall reactions than DTaP-IPV-Hib. It generated markedly higher antibody responses, achieving 98% seroconversion for filamentous hemagglutinin and superior pertussis toxin levels versus the co-purified DTaP. The results support considering DTcP as a stronger alternative for infant pertussis immunization, though larger effectiveness studies are needed.
- Journal
- Frontiers in immunology (Q1)
- Published
- 7 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Wei Zhang, Chen Wei, Haitao Huang, Xue Wang, Zhiqiang Xie, Yan Wu, et al.
- PMID
- 42483174
- DOI
- 10.3389/fimmu.2026.1874647
Why clinicians should know about it
- Picked for Pediatrics and Child Health (paper of the day, 23 July 2026): DTcP vaccine shows superior immunogenicity in 3‑month infants
Abstract
UNLABELLED: This study aimed to evaluate the safety and immunogenicity of a novel diphtheria, tetanus, and pertussis (acellular, three components) combined vaccine, adsorbed (DTcP) vaccine compared to the existing co-purified DTaP vaccine in China. In this partially randomized, blinded, controlled Phase III trial, we assessed a DTcP vaccine against two controls: a licensed co-purified DTaP and a DTaP-IPV-Hib vaccine. A total of 1,140 infants (3 months old) received a 3-dose primary series at 3, 4, and 5 months. Both of DTcP and co-purified DTaP had lower incidences of overall adverse reactions than the DTaP-IPV-Hib vaccine (17.99%/18.08% vs. 21.96%). The DTcP vaccine demonstrated non-inferiority and superiority over the co-purified DTaP for anti-PT and anti-FHA immunogenicity. In addition, the DTcP achieved a 98.16% seroconversion rate for anti-FHA, versus only 14.29% for the co-purified DTaP. Besides, DTcP vaccine also induced high antibody level in GMC results. Specifically, the anti-PT GMC was 85.10 in the DTcP group versus 49.86 in the DTaP group (P < 0.001) and 74.25 in the DTaP-IPV-Hib (P = 0.001). For anti-FHA, the GMC was 108.28 in the DTcP group compared to only 10.69 in the DTaP group. In conclusion, DTcP vaccine induces a significantly more robust immune response to key pertussis antigens --compared to the co-purified DTaP, with a comparable safety profile. These data support the potential optimization of China's immunization strategy by transitioning from co-purified to component-based acellular pertussis vaccines to address waning immunity and the ongoing pertussis resurgence. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov, identifier NCT05951725.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.