Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: An observer-blind, randomized trial
Vaccine·
- DOI
- 10.1016/j.vaccine.2013.07.007
- PMID
- 23856331
- PMCID
- PMC7115432
- OpenAlex
- W2076757133
- Study type
- Randomised controlled trial
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The findings demonstrate that a single dose of either adjuvanted or non-adjuvanted A(H1N1)pdm09 vaccine can induce protective antibody levels that persist through six months in adults aged 18-64 years, informing pandemic vaccination strategies. The adjuvanted formulation achieved comparable immunogenicity with a lower antigen dose, which may support vaccine supply during pandemic responses.
Structured evidence summary
Research question
The study evaluated the immunogenicity and relative protective efficacy of a single dose of AS03-adjuvanted influenza A(H1N1)pdm09 vaccine compared to a non-adjuvanted formulation in healthy adults.
Study design
This was an observer-blind, randomized controlled trial. A total of 4,048 healthy adults aged 18 years and older were randomized 1:1 to receive either adjuvanted (3.75 μg HA/AS03) or non-adjuvanted (15 μg HA) vaccine, with hemagglutination inhibition antibody responses measured at baseline, Days 21, 42, and 182.
Population and setting
The trial enrolled 4,048 healthy adults aged 18 years and older, stratified into two age groups: 18-64 years and over 64 years.
Main findings
Both vaccines met US regulatory criteria at Day 21 in both age groups, with the AS03-adjuvanted vaccine inducing higher geometric mean titers at all time points. At Month 6, only the 18-64 age group from both vaccine groups still met regulatory criteria, with seroprotection rates of 82.1% (adjuvanted) and 75.3% (non-adjuvanted). Protective efficacy could not be evaluated due to insufficient RT-qPCR-confirmed influenza cases.
Public-health relevance
The findings demonstrate that a single dose of either adjuvanted or non-adjuvanted A(H1N1)pdm09 vaccine can induce protective antibody levels that persist through six months in adults aged 18-64 years, informing pandemic vaccination strategies. The adjuvanted formulation achieved comparable immunogenicity with a lower antigen dose, which may support vaccine supply during pandemic responses.
Important limitations
This summary is limited to the supplied single-article abstract and metadata and requires the original paper for decision-grade interpretation. The abstract indicates that protective efficacy could not be evaluated due to low numbers of RT-qPCR-confirmed cases, limiting conclusions about clinical protection.
GIDS interpretation
This article would be discoverable through GIDS queries related to influenza vaccination effectiveness, pandemic influenza A(H1N1)pdm09 immunogenicity, and adjuvanted vaccine formulations. The classifier links connect it to treatment, vaccination, and vaccine effectiveness topics within influenza disease surveillance contexts.
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.