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CompletedNCT04953078Updated Jan 12, 2023

A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19

A Phase 1 interventional study of Baiya SARS-CoV-2 Vax 1 in Coronavirus, sponsored by Baiya Phytopharm Co., Ltd.. Completed at 2 sites in Thailand. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by Baiya Phytopharm Co., Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational product with a 21-day interval.

02

Conditions studied

  • Coronavirus

Keywords

  • SARS-CoV-2
  • SARS-CoV-2 Vaccine
  • COVID-19
  • COVID-19 Vaccine
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 48 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Baiya Phytopharm Co., Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy man and woman between 18-60 years old (inclusive) for the adult cohort and between 61-75 years old (inclusive) for the elderly cohort.
  • Have a body-mass index of 18.0-30.0 kg/m² at screening
  • Give informed consent prior to study enrollment and all study procedures
  • Participants must be able to comply with study procedures and be available for all study visits
  • Participants must be in general good health based on medical history and physical examination as determined by the investigator(s) at Screening
  • 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 clinicallysignificant" per investigator decision based on safety at Screening.
  • 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.
  • 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.
  • 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
  • Female participants of childbearing potential must not be pregnant or breastfeeding.

  • 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 follicle stimulating hormone (FSH) level > 40 milli-international units per millilitre (mIU/mL), or
    3. have a documented status of being surgically sterile (hysterectomy, bilateral oophorectomy, or /salpingectomy).
  • 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
  • Body temperature measured at forehead using validated device must be less than 37.5ºC at Screening.
  • Pulse must be no greater than 100 beats per minute, at Screening
  • Systolic blood pressure (SBP) must be between 85 to 150 millimeters of mercury (mm Hg), inclusive, at Screening
  • Participants must agree to refrain from donating blood, plasma, ovules, sperm, or organs during the whole study

Exclusion criteria

Exclusion Criteria:

  • Presence of clinically significant medical history, unstable chronic or acute disease, or physical, or laboratory findings that in the opinion of the PI 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.
  • 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 participant's interest to participate in the study.
  • Presence of an acute illness, as determined by the participating Study Site investigator(s), with or without fever (forehead temperature measured by validated device ≥ 37.5 ºC) within 72 hours prior to each vaccination
  • Presence of birthmarks, tattoos, wound, or other skin conditions over the deltoid region of both arms that in the opinion of the investigator(s), could reasonably obscure and interfere with evaluation of local ISRs
  • Inadequate venous access to allow collection of blood samples
  • 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
  • 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 to do so in the follow-up period defined for this study
  • 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
  • Participant is immunosuppressed as caused by disease (such as HIV)
  • 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
  • History of hepatitis B or hepatitis C infection
  • Receipt of immunoglobulins or blood products within 90 days of the first vaccination
  • Requirement for antipyretic or analgesic medication on a daily or every other day basis from enrolment through 72 hours after vaccination
  • Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the PI
  • Receipt of other investigational products (drug, biologic or device) within 60 days before the first vaccination
  • History of alcohol or drug abuse that in the opinion of the PI could affect the participant's safety or compliance with study
  • Participant is unwilling to abstain from blood donation during the course of the study, and/or is participating in any research study involving blood sampling (more than 450 mL /unit of blood), or blood donation to any blood bank during the 2 months prior to the Screening visit
  • Participant is unwilling to abstain from donating plasma, ovules, sperm, or organs during the course of the study
  • Close contact with anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration
  • History of COVID-19 diagnosis
  • Has a positive result on SARS-CoV-2 antibody IgG/IgM measured by ELISA at screening
  • On current treatment with investigational agents for prophylaxis of COVID-19 including COVID-19 Vaccine under EUA.
  • Planning to travel out of the country from enrolment through 29 days after the second vaccination
  • Residing in a nursing home or other skilled nursing facility or having a requirement for skilled nursing care
  • Is a participant at high risk of SARS-CoV2 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)
  • A chronic smoker (defined as ≥10 Pack years [packs/day × years smoked]) within the 12 months prior to enrolment (For Elderly Participants only)
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    10 μg Baiya SARS-CoV-2 Vax 1, Adult Participants

    2 doses of Baiya SARS-CoV-2 Vax 1 (10 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old)

    Biological: Baiya SARS-CoV-2 Vax 1

  • Experimental
    50 μg Baiya SARS-CoV-2 Vax 1, Adult Participants

    2 doses of Baiya SARS-CoV-2 Vax 1 (50 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old)

    Biological: Baiya SARS-CoV-2 Vax 1

  • Experimental
    100 μg Baiya SARS-CoV-2 VAX1, Adult Participants

    2 doses of Baiya SARS-CoV-2 VAX1 (100 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old)

    Biological: Baiya SARS-CoV-2 Vax 1

  • Experimental
    10 μg Baiya SARS-CoV-2 VAX1, Elderly Participants

    2 doses of Baiya SARS-CoV-2 VAX1 (10 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old)

    Biological: Baiya SARS-CoV-2 Vax 1

  • Experimental
    50 μg Baiya SARS-CoV-2 VAX1, Elderly Participants

    2 doses of Baiya SARS-CoV-2 VAX1 (50 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old)

    Biological: Baiya SARS-CoV-2 Vax 1

  • Experimental
    100 μg Baiya SARS-CoV-2 VAX1, Elderly Participants

    2 doses of Baiya SARS-CoV-2 VAX1 (100 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old)

    Biological: Baiya SARS-CoV-2 Vax 1

Interventions

  • BiologicalBaiya SARS-CoV-2 Vax 1

    Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 1 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)

06

What researchers measure

Primary outcomes

  1. Frequency and Grade of Solicited Adverse Events

    Time frame: 7 days after each vaccination

  2. Frequency and Grade of Adverse Events (including both solicited and unsolicited AEs)

    Time frame: Up to 28 days after second vaccination

  3. Incidence of Serious Adverse Events (SAEs), Medically-Attended Adverse Events (MAAEs), and New-Onset Chronic Medical Conditions (NOCMCs)

    Time frame: Up to 28 days after second vaccination

  4. Changes in Blood Pressure (Systolic and Diastolic Blood Pressure) from Baseline

    Blood pressure is measured mmHg. Blood pressure, both systolic and diastolic, at multiple timepoints according to the protocol will be compared to baseline value. Changes in blood pressure will be described using descriptive statistic (mean, standard deviation).

    Time frame: Up to 28 days after second vaccination

  5. Changes in Pulse Rate from Baseline

    Pulse rate is measured as beats per minute. Pulse rate at multiple timepoints according to the protocol will be compared to baseline value. Changes in pulse rate will be described using descriptive statistic (mean, standard deviation).

    Time frame: Up to 28 days after second vaccination

  6. Changes in Respiratory Rate from Baseline

    Respiratory rate is measured as breaths per minute. Respiratory rate at multiple timepoints according to the protocol will be compared to baseline value. Changes in respiratory rate will be described using descriptive statistic (mean, standard deviation).

    Time frame: Up to 28 days after second vaccination

  7. Changes in Body Temperature from Baseline

    Body temperature is measured as degree Celsius. Body temperature at multiple timepoints according to the protocol will be compared to baseline value. Changes in body temperature will be described using descriptive statistic (mean, standard deviation)

    Time frame: Up to 28 days after second vaccination

  8. Changes in Physical Conditions from Baseline Physical Examinations

    Baseline physical examination will include head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin. Symptom directed physical examination will be performed for each subsequent visit. Changes in physical conditions from baseline physical examination will be described.

    Time frame: Up to 28 days after second vaccination

  9. Safety Laboratory Value (Haematology)

    Haematology laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  10. Safety Laboratory Value (Serum chemistry)

    Serum Chemistry laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  11. Safety Laboratory Value (Coagulation)

    Coagulation laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  12. Safety Laboratory Value (Urinalysis)

    Urinalysis laboratory value by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0 (absolute and change from baseline where identified). The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  13. Treatment-emergent Changes in Blood Pressure

    Grade of treatment-emergent changes in blood pressure by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  14. Treatment-emergent Changes in Pulse Rate

    Grade of treatment-emergent changes in pulse rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  15. Treatment-emergent Changes in Respiratory Rate

    Grade of treatment-emergent changes in respiratory rate by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  16. Treatment-emergent Changes in Body Temperature

    Grade of treatment-emergent changes in body temperature by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

  17. Treatment-emergent, Changes in Physical Conditions

    Baseline physical examination will include head, ears, nose, throat, lungs, lymph nodes, heart, abdomen and skin. Symptom directed physical examination will be performed for each subsequent visit. Grade of treatment-emergent changes by Common Terminology Criteria for Adverse Event (CTCAE) scale version 5.0. The scale ranges from Grade 1 (Mild) to Grade 5 (Most Severe).

    Time frame: Up to 28 days after second vaccination

Secondary outcomes

  1. Frequency and Grade of Medically-Attended Adverse Events (MAAEs)

    Time frame: 28 days - 1 year after second vaccination

  2. Frequency and Grade of New-Onset Chronic Medical Conditions (NOCMCs)

    Time frame: 28 days - 1 year after second vaccination

  3. Incidence of SAEs

    Time frame: 28 days - 1 year after second vaccination

  4. Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Serum Neutralising Antibody

    SARS-CoV-2 Specific Serum Neutralising Antibody as measured by Micro-neutralization assay, expressed as GMTs for each cohort

    Time frame: Up to 28 days after second vaccination

  5. Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Serum Neutralising Antibody

    SARS-CoV-2 Specific Serum Neutralising Antibody as measured by Micro-neutralization assay, expressed as GMFRs for each cohort

    Time frame: Up to 28 days after second vaccination

  6. Seroconversion Rate of SARS-CoV-2 Specific Serum Neutralising Antibody

    Seroconversion Rate is defined as the proportion of participants who achieves a greater than or equal to 4-fold rise in SARS-CoV-2 specific serum neutralising antibody level from baseline

    Time frame: Up to 28 days after second vaccination

  7. Geometric Mean Titer (GMT) of SARS-CoV-2 Surrogate Viral Neutralising Antibody

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Time frame: Up to 28 days after second vaccination

  8. Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Surrogate Viral Neutralising Antibody

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Time frame: Up to 28 days after second vaccination

  9. Seroconversion Rate of SARS-CoV-2 Surrogate Viral Neutralising Antibody

    Seroconversion Rate is defined as a greater than or equal to 4-fold rise in SARS-CoV-2 surrogate viral neutralising antibody from baseline

    Time frame: Up to 28 days after second vaccination

  10. Geometric Mean Titer (GMT) of RBD-specific IgG Antibody

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Time frame: Up to 28 days after second vaccination

  11. Geometric Mean Fold Rise (GMFR) of RBD-specific IgG Antibody

    Measured by enzyme-linked immunosorbent assay (ELISA)

    Time frame: Up to 28 days after second vaccination

  12. Seroconversion Rate of RBD-specific IgG Antibody

    Measured by enzyme-linked immunosorbent assay (ELISA). Seroconversion Rate is defined as a greater than or equal to 4-fold rise in RBD-specific IgG Antibody from baseline

    Time frame: Up to 28 days after second vaccination

  13. Percentage of participants who have positive RBD-specific CD4+ and CD8+ T-cell IFN-y ELISpot responses

    Measured by IFN-y ELISpot assay

    Time frame: Up to 28 days after second vaccination

  14. Median number of spot-forming cells (SFC) per 1 million PBMCs

    Measured by IFN-y ELISpot assay

    Time frame: Up to 28 days after second vaccination

  15. Percentage of participants who shows positive specific T-helper 1 responses, or T-helper 2 responses

    Quantified by Intracellular Cytokine Staining

    Time frame: Up to 28 days after second vaccination

  16. Medium percentage of specific T-helper 1 responses or T-helper 2 responses

    Quantified by Intracellular Cytokine Staining

    Time frame: Up to 28 days after second vaccination

07

Study locations

2 sites
  • Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University
    Bangkok, 10330, Thailand
  • Queen Saovabha Memorial Institute
    Bangkok, 10330, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04953078
Lead sponsor
Baiya Phytopharm Co., Ltd.
Collaborators
National Vaccine Institute, Thailand
Responsible party
Sponsor
First posted
Jul 7, 2021
Start date
Sep 11, 2021
Primary completion
Dec 2, 2021
Completion
Nov 4, 2022
Last update
Jan 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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