Safety and immunogenicity of a genetically inactivated stand-alone acellular pertussis vaccine as a booster to Australian adults: a randomized, controlled, non-inferiority trial
Vaccine·
- DOI
- 10.1016/j.vaccine.2026.128863
- PMID
- 42349132
- PMCID
- —
- OpenAlex
- —
- Study type
- Randomised controlled trial
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Waning immunity following acellular pertussis vaccination has been observed in pertussis outbreaks, creating a need for more effective acellular pertussis vaccines. The findings support the potential use of this 2-component vaccine as a pertussis booster in adults.
Structured evidence summary
Research question
The study evaluated whether a stand-alone 2-component acellular pertussis vaccine containing genetically inactivated pertussis toxin and filamentous hemagglutinin is non-inferior in immunogenicity and comparable in safety to a licensed 3-component Tdap vaccine in adults.
Study design
This was a randomized controlled non-inferiority trial with 2:1 allocation comparing the 2-component vaccine to a licensed 3-component Tdap vaccine. Participants were stratified by infant priming vaccine type (whole-cell or acellular). Immunogenicity was measured at baseline, 28 days, and 1 year post-vaccination using serum antibody concentrations and neutralizing antibody titers.
Population and setting
The trial enrolled 102 healthy Australian adults aged 18-30 years, including individuals primed in infancy with either whole-cell or acellular pertussis vaccines.
Main findings
The 2-component vaccine met non-inferiority criteria for seroconversion at day 28 for both pertussis toxin IgG (98.5% vs 82.4%, absolute difference 16.1%) and filamentous hemagglutinin IgG (87.7% vs 61.8%, absolute difference 25.9%). Geometric mean concentrations of pertussis toxin IgG and neutralizing antibodies were significantly higher in the 2-component vaccine group at both 28 days and 1 year. Safety profiles were comparable between vaccines, with most adverse events mild to moderate and no vaccine-related serious adverse events.
Public-health relevance
Waning immunity following acellular pertussis vaccination has been observed in pertussis outbreaks, creating a need for more effective acellular pertussis vaccines. The findings support the potential use of this 2-component vaccine as a pertussis booster in adults.
Important limitations
This summary is limited to the supplied single-article abstract and metadata. Assessment of study limitations including sample size adequacy, follow-up duration, clinical endpoint measurement, and generalizability requires review of the complete published article.
GIDS interpretation
This article is discoverable through pertussis, diphtheria, and tetanus disease classifiers as well as vaccination and vaccine effectiveness topic classifiers, reflecting its focus on pertussis vaccine immunogenicity in an Australian adult population. The classifier links provide context for literature searches but do not establish epidemiological surveillance connections.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 12 auditable classifier relationships to diseases, places, topics, and study design.