- A randomized, partially-blinded, prime-boost, 21 days apart, dose escalation phase 1 study
- one 3.75, 7.5 or 15 µg dose admininstered intramuscularly alone or with CpG1018 or AS03
- Participants were SARS-CoV-2 seronegative adults between the ages of 18-55 years
- Primary endpoints of safety and immunogenicity were reported until 42 days after vaccine administration 
- The presence of neutralizing antibodies was determined using a "VSV pseudovirus assay and cellular responses by ELISpot (IFNγ, IL-4)"

Smith College

- Background
- Methods
- Results
- Conclusion

CoVLP Phase 1 Trial

Ward, Brian J., et al. “Phase 1 Trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants.” MedRxiv, Cold Spring Harbor Laboratory Press, Nov. 2020, p. 2020.11.04.20226282. www.medrxiv.org, doi:10.1101/2020.11.04.20226282.

Phase 1 trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants

The plant based vaccine, CoVLP, uses trimeric spike glycoproteins from Nicotiana benthamiana to mimic the size and shape of SARS-CoV-2. Medicago has had previous success utilizing other plant-based vaccines for the Influenza virus and H1N1, so the company decided to develop a VLP vaccine against SARS-CoV-2 as well.

Background of CoVLP Phase 1 Trial

Methods of CoVLP Phase 1 Trial

- all dosages and combinations were well-tolerated, but adjuvants significantly increased reactogenicity (especially after dose 2)
- CoVLP+AS03(adjuvant) had the most severe and frequent adverse. This group also had the highest immunogenicity after dose 1.
- After the first dose, only a weak humoral response. After the second dose, modest cellular responses were elicited.

Results of CoVLP Phase 1 Trial

- CoVLP both with and without adjuvants was well-tolerated
- Several combinations of CoVLP and adjuvants elicited strong humoral and T cell responses after dose 2
- Based on these findings, further clinical evaluation of CoVLP (3.75μg+AS03) to further clinical evaluation is suitable

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