COVID-19 VaccinePhase 2NCT05873374
Evaluation of Safety, Tolerability, Reactogenicity, Immunogenicity of Baiya SARS-CoV-2 Vax 2 as a Booster for COVID-19
A Phase 2 study testing 50 μg Baiya SARS-CoV-2 Vax 2 in people with COVID-19 Vaccine and COVID-19, run by Baiya Phytopharm Co., Ltd. at 1 site in Thailand.
Trial summary
The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease. This is a Phase 2, randomised, and double-blinded study to assess the safety, tolerability, reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine, when used… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine, COVID-19
- What is being tested?
- 50 μg Baiya SARS-CoV-2 Vax 2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2023to Aug 2024
- Phase
- Phase 2
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Participant must be able to comply with study procedures and be available for all study visits.
- Previously receive COVID-19 vaccines either homologous or heterologous vaccination at least 3 doses and the last booster dose for more than 6 months prior to Visit 2 (Day 1).
- Be aged between 18 and 64 years, inclusive, at the time of signing informed consent
- Have a BMI between 18.5 and 35.0 kg/m2 inclusive
- Healthy as determined by the Investigator based on pre-study medical history, physical examination and vital signs
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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 the time of vaccination until 60 days after the vaccination
- Females of childbearing 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* for at least 60 days following vaccination.
- PI to assess the suitability of contraceptive measures on a case-by-case basis. The measures can include: combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, and documented bilateral tubal occlusion hysterectomy, bilateral salpingectomy, bilateral Essure® placement, and bilateral ovariectomy.
Who cannot join
- Known history of COVID-19 infection within 6 months at screening or Visit 2 (Day 1).
- Participants who screen-fail on this criterion may be rescreened.
- Have received any investigational COVID-19 vaccine.
- Have received any other vaccine within 30 days prior to Visit 2 (Day 1) or plan to receive any other vaccine within 30 days after Visit 2 (Day 1) as per the investigator's judgment. Participants who screen-fail on this criterion may be rescreened.
- Have an ongoing AE assessed as related to any prior COVID-19 vaccine or COVID-19 disease as per the investigator's judgment.
- Women who are pregnant, breast feeding or planning to become pregnant within 60 days of vaccination and men who plan to conceive a child within 60 days of vaccination.
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- Has a clinically unstable chronic underlying disease such as hypertension, diabetes mellitus, chronic obstructive pulmonary disease, asthma, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, confound, or limit the assessments specified in the protocol.
- Except for stable symptoms and signs that are medically controlled in the judgment of the investigator, which can be enrolled.
- Anticipating the need for immunosuppressive treatment within the 6 months following Visit 2 (Day 1).
- Being treated with other registered or investigational drug for prophylaxis or treatment of COVID-19 such as EVUSHELD or receive within 6 months prior to vaccination or plan to receive within 6 months after vaccination.
- Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ or bone marrow transplantation, asplenia, primary immunodeficiency diseases and HIV infection.
- Cancer or any malignancy that has been in remission for less than 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Administration of other investigational products, or blood products within 4 weeks prior to Visit 2 (Day 1) or planned administration of investigational products, blood products, blood or tissue donation, or blood transfusion within 6 months after Visit 2 (Day 1).
- Clinically significant abnormalities in clinical laboratory tests during Screening in the opinion of the Investigator.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s) that as judged by the investigator(s) may not be in the participants' interest to participate in the 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.
- History of systemic steroids (prednisone ≥ 20 mg/day for >14 consecutive days) within 3 months prior to screening. Topical, inhaled, intranasal, and intra-articular corticosteroids are allowed regardless of dose.
- Receipt of immunoglobulins or blood products within 90 days prior to vaccination or planned treatment during the study periods.
- Thrombocytopenia or other coagulation disorders for whom IM injections are contraindicated or receiving anticoagulant therapy.*
- Anticoagulant therapy: continuous use of anticoagulants such as coumarin/warfarin or new oral anticoagulants/antiplatelets. The use of aspirin or clopidogrel is acceptable.
- Alcoholism, history of alcohol or drug abuse that, in the opinion of the PI, could affect the participant's safety or compliance with study, or chronic liver disease such as cirrhosis at screening.
- Have received any investigational drug from 30 days prior to Screening until 30 days after receiving the assigned vaccination in this study.
- The Investigator, sub-Investigator, study staff, sponsor, pharmaceutical product development or their family members.
- Presence of tattoo, bruising, or other skin blemish at the administration site that would, in the opinion of the Investigator, inhibit the ability to perform an assessment of local tolerability.
- Positive HBsAg, anti-HCV or anti-HIV tests at Screening
- Active COVID-19 infection or COVID-19 positive based on ATK testing at screening or Visit 2 (Day 1).
- Presence of an acute illness, as determined by the Investigator(s), with or without fever (forehead temperature measured with validated device ≥ 37.5oC) within 72 hours prior to vaccination. Participants who screen-fail on this criterion may be rescreened following a suitable recovery period as determined by the Investigator(s).
- Receipt of herbal medicine (such as products of Andrographis paniculata) within 5 days prior to vaccine administration or within 6 months after vaccination.
- Any other reason which, in the opinion of the Investigator, makes the individual ineligible for the study.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Saovabha Memorial Institute
Bangkok, 10330
Peepattra Wantanasiri, Ph.D., 662 115 9860, peepattra.w@baiyaphytopharm.com
About this study
Official title: A Phase 2 Study to Evaluate the Safety, Tolerability, Reactogenicity, and Immunogenicity of Baiya SARS-CoV-2 Vax 2 Vaccine as a Booster Following Vaccination for COVID-19 in Adults Between 18 and 64 Years
The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease.
This is a Phase 2, randomised, and double-blinded study to assess the safety, tolerability, reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine, when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.
Read the detailed description
This is a Phase 2, randomised, and double-blinded study. The participants will be randomised to receive either the investigational product or the placebo at a ratio of 2:1. 0.5 mL of the assigned vaccine will be administered as an IM injection. Each participant will be followed up for 6 months after vaccination.
The primary objective aims to assess the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 vaccine in adults (18-64 years old) as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.
The secondary objective aims to evaluate safety, tolerability, reactogenicity, and immunogenicity up to 28 days after the booster vaccination.
An interim analysis of all safety and available immunogenicity data up to Visit 6 (Day 29 ±3) will be conducted for the DSMB review.
- Conditions
- COVID-19 Vaccine, COVID-19
- Being tested
- 50 μg Baiya SARS-CoV-2 Vax 2, Placebo
- Keywords
- SARS-CoV-2, SARS-CoV-2 vaccine, COVID-19, COVID-19 Vaccine, Booster vaccine, Plant vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 μg Baiya SARS-CoV-2 Vax 2Biological
Intramuscular injection in the deltoid region of 0.5 mL/dose of 50 μg Baiya SARS-CoV-2 Vax 2
PlaceboOther
Also called 0.9% Sodium Chloride
Intramuscular injection in the deltoid region of 0.5 mL/dose of 0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| 50 μg Baiya SARS-CoV-2 Vax 2 | Experimental | 0.5 mL of Baiya SARS-CoV-2 Vax 2 Vaccine as a booster dose via IM injection on Day 1 for adult participants (18 - 64 years old) Receives: Biological: 50 μg Baiya SARS-CoV-2 Vax 2 |
| Placebo | Placebo comparator | 0.5 mL of placebo via IM injection on Day 1 for adult participants (18 - 64 years old) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, percentage, and severity of solicited local and systemic reactogenicity AEs
Measured: 7-day post administration
Number, percentage, and severity of unsolicited AEs
Measured: Day 1 to 28 days after administration
Number, percentage, and severity of treatment-related AEs
Measured: Day 1 to 28 days after administration
Abnormal clinically significant changes in clinical laboratory tests (haematology, coagulation, chemistry, and urinalysis)
Measured: Day 1 to 28 days after administration
Abnormal clinically significant changes in vital signs
Measured: Day 1 to 28 days after administration
Abnormal clinically significant physical examination
Measured: Day 1 to 28 days after administration
Secondary outcomes (17)
Geometric Mean Titres (GMT) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Measured: at 7, 14, 21 and 28 days after administration
Geometric Mean Fold Rises (GMFR) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Measured: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Seroconversion Rate is defined as the proportion of participants who achieves a greater than or equal to 4-fold rise from baseline
Measured: at 7, 14, 21 and 28 days after administration
GMT of SARS-CoV-2-surrogate viral neutralising antibody
measured by surrogate antibody ELISA
Measured: at 7, 14, 21 and 28 days after administration
GMFR of SARS-CoV-2-surrogate viral neutralising antibody
measured by surrogate antibody ELISA
Measured: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2-surrogate viral neutralising antibody
measured by surrogate antibody ELISA
Measured: at 7, 14, 21 and 28 days after administration
GMT of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Measured: at 14 and 28 days after administration
GMFR of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Measured: at 14 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Measured: at 14 and 28 days after administration
GMT of SARS-CoV-2 RBD-specific IgG antibody
measured by ELISA
Measured: at 7, 14, 21 and 28 days after administration
GMFR of SARS-CoV-2 RBD-specific IgG antibody
measured by ELISA
Measured: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 RBD-specific IgG antibody
measured by ELISA
Measured: at 7, 14, 21 and 28 days after administration
Percentage of participants who have positive specific CD4 and CD8 T-cell IFNγ ELISpot responses (detectable above the assay cut-off)
SARS-CoV-2 RBD-specific CD4+ and CD8+ T-cell responses as measured by IFNγ ELISpot assay
Measured: at 7, 14, 21 and 28 days after administration
Median number of spot-forming cells (SFC) per 1 million PBMCs
SARS-CoV-2 RBD-specific CD4+ and CD8+ T-cell responses as measured by IFNγ ELISpot assay
Measured: at 7, 14, 21 and 28 days after administration
Percentage of participants who show positive specific Th1 responses, or Th2 responses (detectable above the assay cut-off)
SARS-CoV-2 RBD-specific Th1/Th2 polarisation responses quantified by intracellular cytokine staining
Measured: at 7, 14, 21 and 28 days after administration
Median percentage specific Th1/Th2 response of each cohort
SARS-CoV-2 RBD-specific Th1/Th2 polarisation responses quantified by intracellular cytokine staining
Measured: at 7, 14, 21 and 28 days after administration
Number and percentage of serious adverse events (SAEs)
Measured: up to 6 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baiya Phytopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873374
- Sponsor's protocol ID
- Baiya-Vax2-P2a-Boost
- Status last verified
- Nov 2023
- First submitted
- 23 May 2023
- Last updated
- 15 Nov 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety, Tolerability, Reactogenicity, and Immunogenicity of Baiya SARS-CoV-2 Vax 2 Vaccine as a Booster Following Vaccination for COVID-19 in Adults Between 18 and 64 Years
- ClinicalTrials.gov ID
- NCT05873374
- Acronym / sponsor ID
- Baiya-Vax2-P2a-Boost
- Conditions
- COVID-19 Vaccine, COVID-19
- Keywords
- SARS-CoV-2, SARS-CoV-2 vaccine, COVID-19, COVID-19 Vaccine, Booster vaccine, Plant vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Baiya Phytopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 24 May 2023 (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.
The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant to prevent COVID-19 disease.
This is a Phase 2, randomised, and double-blinded study to assess the safety, tolerability, reactogenicity and immunogenicity of Baiya SARS-CoV-2 Vax 2 vaccine, when used as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.
Detailed description
This is a Phase 2, randomised, and double-blinded study. The participants will be randomised to receive either the investigational product or the placebo at a ratio of 2:1. 0.5 mL of the assigned vaccine will be administered as an IM injection. Each participant will be followed up for 6 months after vaccination.
The primary objective aims to assess the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 vaccine in adults (18-64 years old) as a booster vaccination following vaccination with the alternate and widely used COVID-19 vaccines.
The secondary objective aims to evaluate safety, tolerability, reactogenicity, and immunogenicity up to 28 days after the booster vaccination.
An interim analysis of all safety and available immunogenicity data up to Visit 6 (Day 29 ±3) will be conducted for the DSMB review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 μg Baiya SARS-CoV-2 Vax 2 | Experimental | Biological: 50 μg Baiya SARS-CoV-2 Vax 20.5 mL of Baiya SARS-CoV-2 Vax 2 Vaccine as a booster dose via IM injection on Day 1 for adult participants (18 - 64 years old) |
| Placebo | Placebo comparator | Other: Placebo0.5 mL of placebo via IM injection on Day 1 for adult participants (18 - 64 years old) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Participant must be able to comply with study procedures and be available for all study visits.
- Previously receive COVID-19 vaccines either homologous or heterologous vaccination at least 3 doses and the last booster dose for more than 6 months prior to Visit 2 (Day 1).
- Be aged between 18 and 64 years, inclusive, at the time of signing informed consent
- Have a BMI between 18.5 and 35.0 kg/m2 inclusive
Key exclusion criteria (29 listed)
- Known history of COVID-19 infection within 6 months at screening or Visit 2 (Day 1).
- Participants who screen-fail on this criterion may be rescreened.
- Have received any investigational COVID-19 vaccine.
- Have received any other vaccine within 30 days prior to Visit 2 (Day 1) or plan to receive any other vaccine within 30 days after Visit 2 (Day 1) as per the investigator's judgment. Participants who screen-fail on this criterion may be rescreened.
- Have an ongoing AE assessed as related to any prior COVID-19 vaccine or COVID-19 disease as per the investigator's judgment.
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 |
|---|---|---|
| 50 μg Baiya SARS-CoV-2 Vax 2Intramuscular injection in the deltoid region of 0.5 mL/dose of 50 μg Baiya SARS-CoV-2 Vax 2 | Biological | 50 μg Baiya SARS-CoV-2 Vax 2 |
| PlaceboAlso: 0.9% Sodium ChlorideIntramuscular injection in the deltoid region of 0.5 mL/dose of 0.9% Sodium Chloride | Other | Placebo |
Primary outcome
Number, percentage, and severity of solicited local and systemic reactogenicity AEs
Time frame: 7-day post administration
Number, percentage, and severity of unsolicited AEs
Time frame: Day 1 to 28 days after administration
Number, percentage, and severity of treatment-related AEs
Time frame: Day 1 to 28 days after administration
Abnormal clinically significant changes in clinical laboratory tests (haematology, coagulation, chemistry, and urinalysis)
Time frame: Day 1 to 28 days after administration
Abnormal clinically significant changes in vital signs
Time frame: Day 1 to 28 days after administration
Abnormal clinically significant physical examination
Time frame: Day 1 to 28 days after administration
17 secondary outcomes
Geometric Mean Titres (GMT) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Time frame: at 7, 14, 21 and 28 days after administration
Geometric Mean Fold Rises (GMFR) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Time frame: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)
Time frame: at 7, 14, 21 and 28 days after administration
GMT of SARS-CoV-2-surrogate viral neutralising antibody
Time frame: at 7, 14, 21 and 28 days after administration
GMFR of SARS-CoV-2-surrogate viral neutralising antibody
Time frame: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2-surrogate viral neutralising antibody
Time frame: at 7, 14, 21 and 28 days after administration
GMT of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Time frame: at 14 and 28 days after administration
GMFR of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Time frame: at 14 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 variants pseudovirus-specific serum neutralising antibody
Time frame: at 14 and 28 days after administration
GMT of SARS-CoV-2 RBD-specific IgG antibody
Time frame: at 7, 14, 21 and 28 days after administration
GMFR of SARS-CoV-2 RBD-specific IgG antibody
Time frame: at 7, 14, 21 and 28 days after administration
Seroconversion Rate of SARS-CoV-2 RBD-specific IgG antibody
Time frame: at 7, 14, 21 and 28 days after administration
Percentage of participants who have positive specific CD4 and CD8 T-cell IFNγ ELISpot responses (detectable above the assay cut-off)
Time frame: at 7, 14, 21 and 28 days after administration
Median number of spot-forming cells (SFC) per 1 million PBMCs
Time frame: at 7, 14, 21 and 28 days after administration
Percentage of participants who show positive specific Th1 responses, or Th2 responses (detectable above the assay cut-off)
Time frame: at 7, 14, 21 and 28 days after administration
Median percentage specific Th1/Th2 response of each cohort
Time frame: at 7, 14, 21 and 28 days after administration
Number and percentage of serious adverse events (SAEs)
Time frame: up to 6 months after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 μg Baiya SARS-CoV-2 Vax 2 in people with COVID-19 Vaccine and COVID-19, run by Baiya Phytopharm Co., Ltd. at 1 site 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 9 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peepattra Wantanasiri, Ph.D. (662-115-9860, peepattra.w@baiyaphytopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number, percentage, and severity of solicited local and systemic reactogenicity AEs (time frame: 7-day post administration). The study lists 6 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 15 Nov 2023.