NCT04760743

Safety and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults (COVID-19)

Completed Phase 1 Last updated 18 April 2023

What this trial tests

Phase 1 trial testing NBP2001 adjuvanted with alum (RBD 30μg/dose) in COVID-19 (Healthy Volunteers) in 50 participants. Completed in 2 March 2022.

Timeline

17 December 2020

Primary endpoint
2 April 2021

2 March 2022

Quick facts

Lead sponsor	SK Bioscience Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	17 December 2020
Primary completion	2 April 2021
Estimated completion	2 March 2022
Sites	2 locations across South Korea

Drugs / interventions tested

• NBP2001 adjuvanted with alum (RBD 30μg/dose) — full drug profile →
• NBP2001 adjuvanted with alum (RBD 50μg/dose) — full drug profile →
• Normal Saline

Conditions studied

• COVID-19 (Healthy Volunteers) — all drugs for COVID-19 (Healthy Volunteers) →

Sponsor

SK Bioscience Co., Ltd. — full company profile →

Who can join

Adults 19 to 55, any sex, with COVID-19 (Healthy Volunteers). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults.

Publications & conference data

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

1. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
2. The impact of spike mutated variants of SARS-CoV2 [Alpha, Beta, Gamma, Delta, and Lambda] on the efficacy of subunit recombinant vaccines.
   Mohammadi M, Shayestehpour M, Mirzaei H. · · 2021 · cited 99× · PMID 34428473 · DOI 10.1016/j.bjid.2021.101606
3. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
   Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
4. Current view on novel vaccine technologies to combat human infectious diseases.
   Matić Z, Šantak M. · · 2022 · cited 47× · PMID 34889981 · DOI 10.1007/s00253-021-11713-0
5. A Narrative Review of COVID-19 Vaccines.
   Eroglu B, Nuwarda RF, Ramzan I, Kayser V. · · 2021 · cited 38× · PMID 35062723 · DOI 10.3390/vaccines10010062
6. An update review of globally reported SARS-CoV-2 vaccines in preclinical and clinical stages.
   Motamedi H, Ari MM, Dashtbin S, Fathollahi M, et al · · 2021 · cited 34× · PMID 34162141 · DOI 10.1016/j.intimp.2021.107763
7. Diverse vaccine platforms safeguarding against SARS-CoV-2 and its variants.
   Chatterjee B, Thakur SS. · · 2022 · cited 5× · PMID 34697980 · DOI 10.1080/14760584.2022.1997601
8. Clinical progress of therapeutics and vaccines: Rising hope against COVID-19 treatment.
   Bandaru R, Rout SR, Kamble OS, Samal SK, et al · · 2022 · cited 4× · PMID 35437418 · DOI 10.1016/j.procbio.2022.04.011