CovidResearchTrials by Shray Alag

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Matrix-M AdjuvantWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug866 NSS Saline Placebo Wiki 1.00
drug1189 SARS-CoV-2 rS Wiki 1.00
drug354 Control Wiki 0.50
drug1475 Vitamin C Wiki 0.41

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A 2-Part, Phase 1/2, Randomized, Observer-Blinded Study To Evaluate The Safety And Immunogenicity Of A SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Or Without MATRIX-M™ Adjuvant In Healthy Subjects

For Phase 1 only. Additional information will be provided if Phase 2 is implemented. 2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial designed to evaluate the immunogenicity and safety of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 (inclusive) years of age. The study will be conducted in 2 parts. In Part 1, at least 1 and up to two SARS-CoV-2 rS constructs will be evaluated in up to 2 cohorts, which may be enrolled in parallel. An interim analysis of Part 1 safety and immunogenicity data will be performed prior to an optional expansion to Part 2.

NCT04368988 COVID-19 Biological: SARS-CoV-2 rS Other: Matrix-M Adjuvant Other: NSS Saline Placebo

Primary Outcomes

Description: Numbers and percentages (with 95% CIs) of subjects with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity. In the case of no reactogenicity, a toxicity score of zero (0) will be applied.

Measure: Subjects with solicited AEs - Phase 1

Time: 28 days

Description: Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.

Measure: Safety Laboratory Values (serum chemistry, hematology) - Phase 1

Time: 28 days

Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA at Day 21 and Day 35. Derived/calculated endpoints based on these data will include geometric mean ELISA units, geometric mean fold rise, and seroconversion rate (proportion of subjects with ≥4-fold rises in ELISA units).

Measure: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) - Phase 1

Time: 35 days

No related HPO nodes (Using clinical trials)