Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05197712
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-24
First Post:
2022-01-15
Brief Title:
Evaluation of the Safety Tolerability and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease
Sponsor:
Baiya Phytopharm Co Ltd
Organization:
Baiya Phytopharm Co Ltd
Study Overview
Official Title:
A Phase 1 Open-label Study to Evaluate the Safety Tolerability and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
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 investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant The primary objective aiming to evaluate the safety tolerability and reactogenicity of Baiya SARS-CoV-2 Vax 2 in adults aged between 18 to 64 years inclusive after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM up to 28 days after the second vaccination The secondary objective aiming to evaluate long-term safety profile up to 1 year and evaluate immunogenicity after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart
Detailed Description:
The Baiya SARS-CoV-2 Vax 2 investigational vaccine is developed by Baiya Phytopharm Co Ltd for the active immunisation of adults against SARS-CoV-2 which causes coronavirus disease 2019 COVID-19 This first in human FIH study will be conducted in healthy participants Screening for the study will occur within a 42-day window prior to study enrolment All eligible consenting participants will receive Baiya SARS-CoV-2 Vax 2 vaccine at the assigned dose by IM injection according to a repeat vaccination schedule to be given 21 days apart The study is an open-label dose escalation FIH study conducted in healthy adults aged 18 to 64 years inclusive
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