- recombinant nanoparticle vaccine
- constructed from full-length wild-type SARS-CoV-2 spike glycoprotein
- Matrix M1: saponin based adjuvant made by Novavax
- rSARS-CoV-2 and Matrix M1 mixed just before use
- vaccine stored at 2-8C
- placebo: sterile 0.9% normal saline

Santa Clara University

Location:
- Nucleus Network in Herston, Queensland
- Melbourne, Victoria

Participants: 
- 131 healthy adults
- see child node for more details 

Randomized, placebo-control, phase 1-2 trial:
- 5 ug and 25 ug doses with and without Matrix M1 adjuvant
- Phase 1: two intramuscular injections, 21 days apart

Procedure:
- rSARS-CoV-2 and Matrix M1 mixed before injection
- each participant received 2 intramuscular injections of trail vaccine or the placebo in the deltoid muscle

Safety Outcomes: 
- Reactogenicity: track days 0 to 7 and days 21 to 28
- Laboratory values: day 21, and unsolicited adverse events during the first 35 days
- participants also had nasopharyngeal swab testing for SARS-CoV-2 on day 35 or when they reported symptoms
- after each vaccination, participants were observed for at least 30 minutes after

Methods: NVX-CoV2373

Keech, C., Albert, G., Cho, I., Robertson, A., Reed, P., Neal, S., . . . Glenn, G. M. (2020). Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. New England Journal of Medicine. doi:10.1056/nejmoa2026920
https://www.nejm.org/doi/full/10.1056/NEJMoa2026920

Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

- 131 participants
- healthy men and nonpregnant women 18-59 years old
- BMI: 17-35
- people who tested positive or were exposed to COVID-19 were excluded

6 participants:
- 1:1 5ug and 25ug rSARS-CoV-2 plus Matrix-M1 groups 
- open-label manner
- observed for reactogenicity for 48 hours

125 participants:
- 1:1:1:1:1 ratio
- blinded manner received one of 5 vaccine groups

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