Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT05197712
Status:
UNKNOWN
Last Update Posted:
2023-05-24
First Post:
2022-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
True
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?: