CoronavirusPhase 1NCT04953078
A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19
A Phase 1 study testing Baiya SARS-CoV-2 Vax 1 in people with Coronavirus, run by Baiya Phytopharm Co., Ltd. at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Baiya SARS-CoV-2 Vax 1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesThailand
- Study dates
- 11 Sep 2021to 4 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- be classified as being postmenopausal (defined as having a history of amenorrhea for at least one year), or
- 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
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Queen Saovabha Memorial Institute
Bangkok, 10330
About this study
Official title: A Phase 1, Randomized, Open-label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Reactogenicity of Escalating Doses of the Baiya SARS-CoV-2 Vax 1 Vaccine in Healthy Adults
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.
- Conditions
- Coronavirus
- Being tested
- Baiya SARS-CoV-2 Vax 1
- Keywords
- SARS-CoV-2, SARS-CoV-2 Vaccine, COVID-19, COVID-19 Vaccine
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baiya SARS-CoV-2 Vax 1Biological
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)
| Study group | Role | What they receive |
|---|---|---|
| 10 μg Baiya SARS-CoV-2 Vax 1, Adult Participants | Experimental | 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) Receives: Biological: Baiya SARS-CoV-2 Vax 1 |
| 50 μg Baiya SARS-CoV-2 Vax 1, Adult Participants | Experimental | 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) Receives: Biological: Baiya SARS-CoV-2 Vax 1 |
| 100 μg Baiya SARS-CoV-2 VAX1, Adult Participants | Experimental | 2 doses of Baiya SARS-CoV-2 VAX1 (100 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old) Receives: Biological: Baiya SARS-CoV-2 Vax 1 |
| 10 μg Baiya SARS-CoV-2 VAX1, Elderly Participants | Experimental | 2 doses of Baiya SARS-CoV-2 VAX1 (10 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old) Receives: Biological: Baiya SARS-CoV-2 Vax 1 |
| 50 μg Baiya SARS-CoV-2 VAX1, Elderly Participants | Experimental | 2 doses of Baiya SARS-CoV-2 VAX1 (50 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old) Receives: Biological: Baiya SARS-CoV-2 Vax 1 |
| 100 μg Baiya SARS-CoV-2 VAX1, Elderly Participants | Experimental | 2 doses of Baiya SARS-CoV-2 VAX1 (100 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old) Receives: Biological: Baiya SARS-CoV-2 Vax 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Grade of Solicited Adverse Events
Measured: 7 days after each vaccination
Frequency and Grade of Adverse Events (including both solicited and unsolicited AEs)
Measured: Up to 28 days after second vaccination
Incidence of Serious Adverse Events (SAEs), Medically-Attended Adverse Events (MAAEs), and New-Onset Chronic Medical Conditions (NOCMCs)
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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)
Measured: Up to 28 days after second vaccination
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.
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
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).
Measured: Up to 28 days after second vaccination
Secondary outcomes (16)
Frequency and Grade of Medically-Attended Adverse Events (MAAEs)
Measured: 28 days - 1 year after second vaccination
Frequency and Grade of New-Onset Chronic Medical Conditions (NOCMCs)
Measured: 28 days - 1 year after second vaccination
Incidence of SAEs
Measured: 28 days - 1 year after second vaccination
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
Measured: Up to 28 days after second vaccination
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
Measured: Up to 28 days after second vaccination
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
Measured: Up to 28 days after second vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Up to 28 days after second vaccination
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
Measured: Up to 28 days after second vaccination
Geometric Mean Titer (GMT) of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of RBD-specific IgG Antibody
Measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Up to 28 days after second vaccination
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
Measured: Up to 28 days after second vaccination
Percentage of participants who have positive RBD-specific CD4+ and CD8+ T-cell IFN-y ELISpot responses
Measured by IFN-y ELISpot assay
Measured: Up to 28 days after second vaccination
Median number of spot-forming cells (SFC) per 1 million PBMCs
Measured by IFN-y ELISpot assay
Measured: Up to 28 days after second vaccination
Percentage of participants who shows positive specific T-helper 1 responses, or T-helper 2 responses
Quantified by Intracellular Cytokine Staining
Measured: Up to 28 days after second vaccination
Medium percentage of specific T-helper 1 responses or T-helper 2 responses
Quantified by Intracellular Cytokine Staining
Measured: Up to 28 days after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start11 Sep 2021
- Primary completion2 Dec 2021
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baiya Phytopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Vaccine Institute, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953078
- Sponsor's protocol ID
- PT-CR-001
- Status last verified
- Jan 2023
- First submitted
- 14 Jun 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Reactogenicity of Escalating Doses of the Baiya SARS-CoV-2 Vax 1 Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT04953078
- Acronym / sponsor ID
- PT-CR-001
- Conditions
- Coronavirus
- Keywords
- SARS-CoV-2, SARS-CoV-2 Vaccine, COVID-19, COVID-19 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baiya Phytopharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Vaccine Institute, Thailand
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 10 μg Baiya SARS-CoV-2 Vax 1, Adult Participants | Experimental | Biological: Baiya SARS-CoV-2 Vax 12 doses of Baiya SARS-CoV-2 Vax 1 (10 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old) |
| 50 μg Baiya SARS-CoV-2 Vax 1, Adult Participants | Experimental | Biological: Baiya SARS-CoV-2 Vax 12 doses of Baiya SARS-CoV-2 Vax 1 (50 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old) |
| 100 μg Baiya SARS-CoV-2 VAX1, Adult Participants | Experimental | Biological: Baiya SARS-CoV-2 Vax 12 doses of Baiya SARS-CoV-2 VAX1 (100 μg), each on Day 1 and Day 22 for adult participants (18 - 60 years old) |
| 10 μg Baiya SARS-CoV-2 VAX1, Elderly Participants | Experimental | Biological: Baiya SARS-CoV-2 Vax 12 doses of Baiya SARS-CoV-2 VAX1 (10 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old) |
| 50 μg Baiya SARS-CoV-2 VAX1, Elderly Participants | Experimental | Biological: Baiya SARS-CoV-2 Vax 12 doses of Baiya SARS-CoV-2 VAX1 (50 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old) |
| 100 μg Baiya SARS-CoV-2 VAX1, Elderly Participants | Experimental | Biological: Baiya SARS-CoV-2 Vax 12 doses of Baiya SARS-CoV-2 VAX1 (100 μg), each on Day 1 and Day 22 for elderly participants (61 - 75 years old) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baiya SARS-CoV-2 Vax 1Intramuscular 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) | Biological | 10 μg Baiya SARS-CoV-2 VAX1, Elderly Participants, 10 μg Baiya SARS-CoV-2 Vax 1, Adult Participants, 100 μg Baiya SARS-CoV-2 VAX1, Adult Participants, 100 μg Baiya SARS-CoV-2 VAX1, Elderly Participants, 50 μg Baiya SARS-CoV-2 VAX1, Elderly Participants, 50 μg Baiya SARS-CoV-2 Vax 1, Adult Participants |
Primary outcome
Frequency and Grade of Solicited Adverse Events
Time frame: 7 days after each vaccination
Frequency and Grade of Adverse Events (including both solicited and unsolicited AEs)
Time frame: Up to 28 days after second vaccination
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
Changes in Blood Pressure (Systolic and Diastolic Blood Pressure) from Baseline
Time frame: Up to 28 days after second vaccination
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).
Changes in Pulse Rate from Baseline
Time frame: Up to 28 days after second vaccination
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).
Changes in Respiratory Rate from Baseline
Time frame: Up to 28 days after second vaccination
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).
Changes in Body Temperature from Baseline
Time frame: Up to 28 days after second vaccination
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)
Changes in Physical Conditions from Baseline Physical Examinations
Time frame: Up to 28 days after second vaccination
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.
Safety Laboratory Value (Haematology)
Time frame: Up to 28 days after second vaccination
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).
Safety Laboratory Value (Serum chemistry)
Time frame: Up to 28 days after second vaccination
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).
Safety Laboratory Value (Coagulation)
Time frame: Up to 28 days after second vaccination
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).
Safety Laboratory Value (Urinalysis)
Time frame: Up to 28 days after second vaccination
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).
Treatment-emergent Changes in Blood Pressure
Time frame: Up to 28 days after second vaccination
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).
Treatment-emergent Changes in Pulse Rate
Time frame: Up to 28 days after second vaccination
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).
Treatment-emergent Changes in Respiratory Rate
Time frame: Up to 28 days after second vaccination
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).
Treatment-emergent Changes in Body Temperature
Time frame: Up to 28 days after second vaccination
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).
Treatment-emergent, Changes in Physical Conditions
Time frame: Up to 28 days after second vaccination
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).
16 secondary outcomes
Frequency and Grade of Medically-Attended Adverse Events (MAAEs)
Time frame: 28 days - 1 year after second vaccination
Frequency and Grade of New-Onset Chronic Medical Conditions (NOCMCs)
Time frame: 28 days - 1 year after second vaccination
Incidence of SAEs
Time frame: 28 days - 1 year after second vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Serum Neutralising Antibody
Time frame: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Serum Neutralising Antibody
Time frame: Up to 28 days after second vaccination
Seroconversion Rate of SARS-CoV-2 Specific Serum Neutralising Antibody
Time frame: Up to 28 days after second vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Time frame: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Time frame: Up to 28 days after second vaccination
Seroconversion Rate of SARS-CoV-2 Surrogate Viral Neutralising Antibody
Time frame: Up to 28 days after second vaccination
Geometric Mean Titer (GMT) of RBD-specific IgG Antibody
Time frame: Up to 28 days after second vaccination
Geometric Mean Fold Rise (GMFR) of RBD-specific IgG Antibody
Time frame: Up to 28 days after second vaccination
Seroconversion Rate of RBD-specific IgG Antibody
Time frame: Up to 28 days after second vaccination
Percentage of participants who have positive RBD-specific CD4+ and CD8+ T-cell IFN-y ELISpot responses
Time frame: Up to 28 days after second vaccination
Median number of spot-forming cells (SFC) per 1 million PBMCs
Time frame: Up to 28 days after second vaccination
Percentage of participants who shows positive specific T-helper 1 responses, or T-helper 2 responses
Time frame: Up to 28 days after second vaccination
Medium percentage of specific T-helper 1 responses or T-helper 2 responses
Time frame: Up to 28 days after second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baiya SARS-CoV-2 Vax 1 in people with Coronavirus, run by Baiya Phytopharm Co., Ltd. at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Grade of Solicited Adverse Events (time frame: 7 days after each vaccination). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.