CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

NSS Saline PlaceboWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug717 SARS-CoV-2 rS Wiki 1.00
drug495 Matrix-M Adjuvant Wiki 1.00

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

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)