Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05656508
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2022-12-02
Brief Title:
ARVAC - A New Recombinant Coronavirus Disease 2019 COVID-19 Vaccine
Sponsor:
Laboratorio Pablo Cassara SRL
Organization:
Laboratorio Pablo Cassara SRL
Study Overview
Official Title:
Phase 1 Study to Evaluate Safety Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine ARVAC CG Against Severe Acute Respiratory Syndrome Coronavirus SARS-CoV-2 in a Population of Healthy Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 ARVAC-CG in healthy adult volunteers previously vaccinated against the SARS-CoV-2 virus
The main questions it aims to answer are
What is the safety and tolerability profile of the two-dose schedule of this new vaccine
What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period
The main questions it aims to answer are
What is the safety and tolerability profile of the two-dose schedule of this new vaccine
What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None