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Intranasal Administration of Recombinant Influenza Vaccines in Chimeric Mouse Models to Study Mucosal Immunity
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Gastrointestinal Events in High-Dose vs Standard-Dose Influenza Vaccine Recipients
H Keipp Talbot1, Andrew J Dunning2, Corwin A Robertson2
1Vanderbilt University Medical Center, Nashville, Tennessee.
Open Forum Infectious Diseases
|June 27, 2018
Summary
High-dose inactivated influenza vaccine (IIV-HD) did not increase serious gastrointestinal events compared to standard-dose vaccines, despite earlier surveillance signals. This large clinical trial provides reassurance regarding IIV-HD safety.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Passive surveillance suggested a potential link between high-dose inactivated influenza vaccine (IIV-HD) and gastrointestinal adverse events.
- Concerns regarding gastrointestinal safety needed further investigation through robust clinical trials.
Purpose of the Study:
- To prospectively evaluate the incidence of serious gastrointestinal events following administration of high-dose inactivated influenza vaccine (IIV-HD).
- To compare the safety profile of IIV-HD with standard-dose influenza vaccine concerning gastrointestinal adverse events.
Main Methods:
- A large, prospective, randomized clinical trial was conducted.
- Participants received either high-dose inactivated influenza vaccine (IIV-HD) or a standard-dose influenza vaccine.
Main Results:
- The rates of serious gastrointestinal events were comparable between the IIV-HD group and the standard-dose vaccine group.
- No statistically significant increase in gastrointestinal adverse events was observed in recipients of IIV-HD.
Conclusions:
- High-dose inactivated influenza vaccine (IIV-HD) is not associated with an increased risk of serious gastrointestinal events compared to standard-dose vaccines.
- The findings from this trial help to clarify the safety profile of IIV-HD for gastrointestinal adverse events.
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