Santa Clara University

Trial Population:
- 25 received 25ug doses of rSARS-CoV-2
- 29 received 5ug doses of rSARS-CoV-2 + Matrix M1
- 28 received 25ug doses of rSARS-CoV-2 + Matrix M1
- 26 received 25ug doses of rSARS-CoV-2 + Matrix M1 with second vaccination as a single dose placebo
- 23 received a placebo

Safety Outcomes:
- no serious adverse events were reported
- reactogenicity: absent of mild
- only one person had a fever that lasted 1 day

Immunogenicity:
- Day 0: anti-spike IgG GMEUs ranged from 105-116
- Day 21: induced without adjuvant by a factor of at least 10
- Day 28: with adjuvant GMEUs increased by a factor of 8
- Day 35: responses had more than doubled again
- achieved GMFRs that were approx 100x greater than observed with rSARS-CoV-2 alone
- responses in 5ug and 25ug adjuvanted vaccines were similar

Neutralizing antibodies:
- Undetectable before vaccination
- Day 21: GMFRs were approx 5x greater with adjuvant
- Day 35:  second vaccine with adjuvant increased 100x than single vaccination without adjuvant
- Approached level that would be observed in hospitalized patients with COIVD-19

Conclusion: 
- At day 35, ELISE anti-spike IgG GMEUS and neutralizing antibodies induced by 5ug and 25ug adjuvanted vaccines doses were 4-6x greater 
- two dose of 5ug and 25ug with Matrix M1 had similar magnitude response
- strong bias toward Th1 phenotype

Results: NVX-CoV2373 Vaccine

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

Adverse Events (Localized) from NVX-CoV2372

Adverse Events (Systemic) from NVX-CoV2373

Anti-Spike IgG
- placebo: no anti spike
- 25ug/25ug: small anti spike similar to an asymptomatic patient
- 5ug/25ug + Matrix M1: anti-spike values correlated to a hospitalized/outpatient symptomatic in human convalescent serum
- 25ug/25ug + Matrix M1:  anti spike less than 5ug/25u trial, similar values to asymptomatic/outpatient symptomatic

Microneutralization
- placebo: no response
- 25ug/25ug: small response similar to an asymptomatic patient
- 5ug/25ug + Matrix M1: values correlated to a hospitalized/outpatient symptomatic in human convalescent serum
- 25ug/25ug + Matrix M1:  neutralization value corrolates to asymptomatic patient 

Learn Before

Related