NCT04368988

Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant

Completed Phase 1, PHASE2 Last updated 10 April 2023

What this trial tests

Phase 1, PHASE2 trial testing SARS-CoV-2 rS - Phase 1 in COVID-19 in 1,419 participants. Completed in 1 June 2022.

Timeline

25 May 2020

Primary endpoint
1 June 2022

1 June 2022

Quick facts

Lead sponsor	Novavax
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,419
Start date	25 May 2020
Primary completion	1 June 2022
Estimated completion	1 June 2022
Sites	18 locations across United States, Australia

Drugs / interventions tested

• SARS-CoV-2 rS - Phase 1 — full drug profile →
• SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 — full drug profile →
• Normal saline solution (NSS), Placebo - Phase 1
• Normal saline solution (NSS), Placebo - Phase 2
• SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 — full drug profile →
• Normal saline solution (NSS), Placebo, Day 21 - Phase 1
• SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2 — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Novavax — full company profile →

Who can join

Adults 18 to 84, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunology of COVID-19: Current State of the Science.
   Vabret N, Britton GJ, Gruber C, Hegde S, et al · · 2020 · cited 1248× · PMID 32505227 · DOI 10.1016/j.immuni.2020.05.002
2. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine.
   Keech C, Albert G, Cho I, Robertson A, et al · · 2020 · cited 928× · PMID 32877576 · DOI 10.1056/nejmoa2026920
3. Immunological considerations for COVID-19 vaccine strategies.
   Jeyanathan M, Afkhami S, Smaill F, Miller MS, et al · · 2020 · cited 697× · PMID 32887954 · DOI 10.1038/s41577-020-00434-6
4. COVID-19 Vaccine: A comprehensive status report.
   Kaur SP, Gupta V. · · 2020 · cited 482× · PMID 32800805 · DOI 10.1016/j.virusres.2020.198114
5. SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice.
   Tian JH, Patel N, Haupt R, Zhou H, et al · · 2021 · cited 400× · PMID 33446655 · DOI 10.1038/s41467-020-20653-8
6. COVID-19: A Review on the Novel Coronavirus Disease Evolution, Transmission, Detection, Control and Prevention.
   Sharma A, Ahmad Farouk I, Lal SK. · · 2021 · cited 345× · PMID 33572857 · DOI 10.3390/v13020202
7. SARS-CoV-2 variant B.1.1.7 is susceptible to neutralizing antibodies elicited by ancestral spike vaccines.
   Shen X, Tang H, McDanal C, Wagh K, et al · · 2021 · cited 331× · PMID 33705729 · DOI 10.1016/j.chom.2021.03.002
8. COVID-19 vaccine development: milestones, lessons and prospects.
   Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y