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Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease

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

NCT05197712•Baiya Phytopharm Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy man or woman between 18 to 64 years old (inclusive).
•2. Give informed consent prior to study enrolment and all study procedures.
•3. Participant must be able to comply with study procedures and be available for all study visits.
•4. Participants must be in general good health based on medical history and physical examination as determined by the investigator(s) at Screening.
•5. Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), practice true abstinence, or, if engaged in sexual activities with a female with childbearing potential, use condoms from first vaccination until 60 days after the last vaccination.
•6. Females of child-bearing potential must practice true abstinence, or, if engaged in sexual activities with a male, agree to use highly effective (failure rate of \<1% per year when used consistently and correctly), double-barrier contraceptive measures throughout the study and intend to continue use of contraception methods for at least 60 days following the last vaccination.
•7. Female participants of childbearing potential must not be pregnant or breastfeeding.
•8. Body temperature measured at forehead using validated device must be less than 37.5ºC at Screening.
•9. Pulse must be no greater than 100 beats per minute at Screening.
•10. Systolic blood pressure (SBP) must be between 90 to 160 millimetres of mercury (mmHg), inclusive, at Screening.
+8 more criteria

Exclusion Criteria

•1. Presence of clinically significant medical history, unstable chronic or acute disease, or physical or laboratory findings that in the opinion of the investigator(s) may potentially increase the expected risk of exposure to the investigational vaccine, compromise the safety of the participant, or interfere with any aspect of study conduct or interpretation of results. This will include any thrombocytopenia or bleeding disorder contraindicating IM vaccination.
•2. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participants' interest to participate in the study.
•3. Presence of birthmarks, tattoos, wound, or other skin conditions over the deltoid region of both arms that in the opinion of the investigator, could reasonably obscure and interfere with evaluation of local ISRs.
•4. Inadequate venous access to allow collection of blood samples.
•5. Breastfeeding or planning to breastfeed from the time of the first vaccination to after the last vaccination, or pregnant as confirmed by a positive serum β-HCG pregnancy test at Screening or positive urine pregnancy test at subsequent clinic visits at timepoints as delineated in the schedule of assessments.
•6. Received any prophylactic or therapeutic vaccine, or licensed or unlicensed vaccine, device, or blood product, within 4 weeks of first vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study.
•7. History of severe allergy (requiring hospital care), anaphylaxis, severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine or tobacco.
•8. Participant is immunosuppressed as caused by disease (such as HIV)
•9. Chronic use (more than 14 continuous days) of, or anticipated need to use, within the next 6 months of any medications that may be associated with impaired immune responsiveness or with immunosuppression.
•10. History of hepatitis B or hepatitis C infection.
+15 more criteria

Locations (1)

Queen Saovabha Memorial Institute

Bangkok, Thailand

Key Dates

Start Date

March 28, 2022

Primary Completion Date

May 29, 2023

Completion Date

April 10, 2024

Last Updated

May 24, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19 Vaccine

Interventions

25 Baiya SARS-CoV-2 Vax 2

BIOLOGICAL

50 Baiya SARS-CoV-2 Vax 2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease

Inclusion Criteria

Exclusion Criteria

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