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
Brief Summary

The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation ofprotein 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 to64 years, inclusive) after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM, upto 28 days after the second vaccination. The secondary objective aiming to evaluatelong-term safety profile (up to 1 year) and evaluate immunogenicity after 2 doses ofBaiya 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).

Unknown status
COVID-19 Vaccine

Biological: 25 Baiya SARS-CoV-2 Vax 2

Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 2
(recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1
vaccine)

Biological: 50 Baiya SARS-CoV-2 Vax 2

Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 2
(recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1
vaccine)

Eligibility Criteria

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.

11. Participants must agree to refrain from donating blood, plasma, ovules, or sperm
during the whole study.

12. Participants must have haematology, clinical chemistry, coagulation, and urinalysis
test results that are not deviating from the normal reference range by age and
gender or considered "not clinically significant" per investigator decision based on
safety at Screening.

13. Female participants of child-bearing potential must have negative serum pregnancy
test by beta human chorionic gonadotropin [β-HCG] at Screening and a negative
urine-based pregnancy test within 24 hours prior to each investigational vaccine
administration.

14. Women of non-child-bearing potential must:

1. be classified as being postmenopausal (defined as having a history of
amenorrhea for at least one year), or

2. where history of amenorrhea is less than one-year, female participants must
have a FSH level > 40 milli-international units per millilitre (mIU/mL), or

3. have a physical examination for evidence of being surgically sterile
(hysterectomy, bilateral oophorectomy, or salpingectomy).

15. All volunteers will be screened for serum antibodies against SARS-CoV-2 as evidence
of previous infection using Enzyme-Linked Immunosorbent Assay (ELISA) and must have
a negative result.

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.

11. Receipt of immunoglobulins or blood products within 90 days of the first
vaccination.

12. Receipt of other investigational products (drug, biologic, or device) within 60 days
before the first vaccination.

13. History of alcohol or drug abuse that, in the opinion of the PI, could affect the
participant's safety or compliance with study.

14. Participant is unwilling to abstain from blood donation during the course of the
study, and/or is participating in any research study involving more blood sampling.

15. Participant is unwilling to abstain from donating plasma, ovules, sperm, or organs
during the study.

16. Close contact with anyone known to have SARS-CoV-2 infection within 30 days prior to
vaccine administration.

17. History of COVID-19 diagnosis.

18. On current treatment with investigational agents for prophylaxis of COVID-19
including COVID-19 Vaccine under EUA.

19. Planning to travel out of the country from enrolment through 29 days after the
second vaccination.

20. Residing in a nursing home or other skilled nursing facility or having a requirement
for skilled nursing care.

21. Is a participant at high risk of SARS-CoV-2 exposure in the opinion of the PI,
including but not limited to an occupation (e.g., healthcare workers, active health
care workers with direct patient contact, emergency response personnel) or close
contact with a SARS-CoV-2 positive confirmed case (e.g., family member, housemate).

22. Presence of an acute illness, as determined by the participating Study Site
investigator(s), with or without fever (forehead temperature measured with validated
device ≥ 37.5 ºC) within 72 hours prior to each vaccination

23. Requirement for antipyretic or analgesic medication on a daily or every other day
basis from enrolment through 72 hours after vaccination.

24. Current use of any prescription or over-the-counter medications within 7 days prior
to vaccination, unless approved by the PI.

25. Has a positive result on SARS-CoV-2 antibody IgG/IgM measured by enzyme-linked
immunosorbent assay (ELISA) at Screening.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 64 Years
Countries
Thailand
Locations

Queen Saovabha Memorial Institute
Bangkok, Thailand

Not Provided

National Vaccine Institute, Thailand
NCT Number
Keywords
SARS-CoV-2
SARS-CoV-2 Vaccine
Covid-19
COVID-19 vaccine
MeSH Terms
COVID-19