Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Jul;91(1):106515.
doi: 10.1016/j.jinf.2025.106515. Epub 2025 May 23.

Immune impacts of infant whole-cell and acellular pertussis vaccination on co-administered vaccines

Affiliations
Free article
Randomized Controlled Trial

Immune impacts of infant whole-cell and acellular pertussis vaccination on co-administered vaccines

Gladymar Pérez Chacón et al. J Infect. 2025 Jul.
Free article

Abstract

Objectives: We compared the effect of a heterologous wP/aP/aP primary series (hereafter mixed wP/aP) versus a homologous aP/aP/aP primary schedule (hereafter aP-only) on antibody responses to co-administered vaccine antigens in infants and toddlers.

Methods: We randomised Australian infants in a 1:1 ratio to receive either a mixed wP/aP schedule (pentavalent diphtheria-tetanus-wP-hepatitis B-Haemophilus influenzae type b; DTwP-HepB-Hib vaccine at 6 weeks old, followed by hexavalent DTaP-inactivated poliovirus vaccine (IPV)-HepB-Hib vaccine at 4 and 6 months old) or aP-only priming doses of hexavalent DTaP-IPV-HepB-Hib vaccine at the same ages. All infants received 13-valent pneumococcal conjugate vaccine (13vPCV) at 6 weeks, 4 and 12 months of age and DTaP-IPV and Hib vaccine boosters at 18 months. We assessed whether the wP/aP schedule is non-inferior to the aP-only schedule for co-administered vaccine antigens (geometric mean ratio [GMR] >2/3).

Registration: ACTRN12617000065392p.

Results: Between March 2018 and January 2020, 150 infants were randomised (75 per arm). Responses to all 13vPCV serotypes and Hib-PRP at 6, 7, 18, and 19 months old, as well as HBsAg at 6 and 7 months old, were non-inferior (>90% probability).

Conclusion: A mixed wP/aP schedule resulted in non-inferior IgG responses to co-administered vaccine antigens compared to the standard aP-only schedule for pertussis primary immunisation.

Keywords: Diphtheria-Tetanus-Pertussis Vaccine/immunology; Diphtheria-Tetanus-acellular Pertussis Vaccines; Haemophilus Vaccines; Hepatitis B Vaccines; Pneumococcal Conjugate Vaccine; Vaccines, Combined; Vaccines, Conjugate/immunology.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: DEC reports personal fees from NSW Health (salary); personal fees from DBV technologies (employment and shares); personal fees from Westmead Fertility Centre (honorarium) and grants from the Australian NHMRC and FARE (Food Allergy Research and Education) outside the submitted work during the conduct of the study. PCR has received investigator-initiated research grants to his institution from MSD and Sanofi outside the submitted work and has received institutional funding from GlaxoSmithKline and Sanofi for local and international lectures and from AstraZeneca, GlaxoSmithKline, MSD, Sanofi, and Pfizer for participation in vaccine scientific advisory boards unrelated to this work. KPP has received research grants from NIAID, Aravax, DBV Technologies, Novartis, and Siolta paid to their institution, outside the submitted work. KPP has received consultant fees from Aravax and Novartis paid to their institution, outside the submitted work. KPP is the chair of the Scientific Advisory Board for AllergyPal (MCRI founded digital app). KPP is a Director on the Board of Omnisova Pty Ltd. All other authors declare no competing interests.

Publication types

MeSH terms