NCT04683484

A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers

Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.

Detailed description

The clinical trial Phase 1, open-label, dose-escalation to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine Nanocovax intramuscularly in healthy Vietnamese adult volunteers. The clinical trial Phase 2, randomization, double-blind, multicenter, placebo-controlled to evaluate the safety, immunogenicity, and determined the optimal dose of the Vaccine Nanocovax intramuscularly in healthy volunteers.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Nanocovax	Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)
BIOLOGICAL	Placebo	0,5 mg Al PO4

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-06-10
• Completion: 2021-08-10
• First posted: 2020-12-24
• Last updated: 2020-12-29

Locations

1 site across 1 country: Vietnam