Clinical Trial of H1ssF Vaccine vs. Seasonal Influenza Vaccine in Previously Unvaccinated Adults and Previously Vaccinated Adults
University of Minnesota
Summary
This is a two-arm, open-label, randomized, phase 1, controlled clinical trial intended to evaluate the safety and immunologic response to the experimental vaccine H1ssF (H1 stabilized stem ferritin nanoparticle) and the seasonal flu vaccine Flucelvax.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults aged 18-70 years inclusive. * Previous influenza immunization status: 1. MN participants must have received at least 3 licensed seasonal flu vaccine doses over the past 5 years (fall or winter of 2021-2025). 2. MN participants should have a gap of at least 6 months between their last seasonal flu vaccine and study enrollment. 3. Uganda participants must have no prior exposure to any flu vaccine. * The participant is able and willing to provide informed consent. * Medical chart review and medical history without clinically significant findings or concerns. *…
Interventions
- BiologicalH1ssF vaccine
Experimental influenza vaccine
- BiologicalFlucelvax seasonal vaccine
Licensed influenza vaccine
Location
- University of MinnesotaMinneapolis, Minnesota