Study on H7N9 Influenza Vaccine Effectiveness in Adults
Author Information
Author(s): Andrew Hastie, Tanya Clarke, Sophie Germain, Thierry Ollinger, Patricia Lese, Vinay Gupta
Primary Institution: GSK
Hypothesis
Does the AS03-adjuvanted H7N9 influenza vaccine elicit an immune response and is it safe for adults aged 18-64 and those aged 65 and older?
Conclusion
The study did not achieve its primary objective of meeting immunogenicity criteria for the H7N9 vaccine at any dose level.
Supporting Evidence
- The vaccine did not meet the immunogenicity criteria set by the CBER.
- Injection site pain and fatigue were the most common side effects.
- Older adults showed lower immune responses compared to younger adults.
- AS03A adjuvanted vaccines showed a trend of increased immune responses compared to AS03B.
Takeaway
The vaccine didn't work as well as hoped, especially for older people, so more research is needed to make better vaccines for future flu outbreaks.
Methodology
Participants were randomized to receive one of six adjuvanted vaccines or placebo, and their immune responses and safety were evaluated.
Potential Biases
Potential bias due to the study being sponsored by GSK.
Limitations
The study did not assess cellular immunity and relied solely on HAI and MN assays for immunogenicity evaluation.
Participant Demographics
Participants included healthy adults aged 18 and older, with a mean age of 44.8 years in the younger group and 72.1 years in the older group; 58.7% were women.
Statistical Information
Confidence Interval
99.17%
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website