drugset / Trial / NCT05029856

Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults

NCT05029856

Phase 1/2 Withdrawn Novavax
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).

Timeline

Start
2022-02-04
Primary completion
2022-08
Completion
2022-08

Drugs

EvaluationDrugModalityDoseRoute
Subject SII B.1.351 Vaccine 3 ug Intramuscular
Subject SII B.1.351 Vaccine 5 ug Intramuscular
Subject SII B.1.617.2 Vaccine 5 ug Intramuscular
Subject SII Bivalent Vaccine 6 ug Intramuscular
Subject SII Bivalent Vaccine 10 ug Intramuscular
Background Matrix-M1 Other / unclassified 50 ug Intramuscular

Indications