Name (Synonyms) | Correlation | |
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drug682 | Matrix-M Adjuvant Wiki | 1.00 |
drug1419 | vaccine candidate MVA-MERS-S Wiki | 1.00 |
drug991 | SARS-CoV-2 rS Wiki | 1.00 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
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 daysDescription: 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 daysDescription: 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