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

NCT05197712 | Unknown Phase 1 DMC

• 1 other identifier: Baiya-Vax2-P1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant. The primary objective aiming to evaluate the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 in adults (aged between 18 to 64 years, inclusive) after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM, up to 28 days after the second vaccination. The secondary objective aiming to evaluate long-term safety profile (up to 1 year) and evaluate immunogenicity after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart.

Conditions

COVID-19 Vaccine

Keywords

SARS-CoV-2; SARS-CoV-2 vaccine; COVID-19; COVID-19 Vaccine

Outcome Measures

Primary Outcomes (17)

• Frequency and grade of solicited local and systemic reactogenicity AEs

  7-day post each vaccination

• Frequency and grade of AEs

  Post-vaccination - 28 days after second vaccination

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

  Post-vaccination - 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).

  Post-vaccination - 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).

  Post-vaccination - 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).

  Post-vaccination - 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)

  Post-vaccination - 28 days after second vaccination

• Changes in Physical Examinations from Baseline

  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.

  Post-vaccination - 28 days after second vaccination

• Clinically relevant changes in haematology laboratory measurements

  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).

  Up to 28 days after second vaccination

• Clinically relevant changes in blood chemistry laboratory measurements

  Blood 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).

  Up to 28 days after second vaccination

• Clinically relevant changes in coagulation laboratory measurements

  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).

  Up to 28 days after second vaccination

• Clinically relevant changes in urinalysis laboratory measurements

  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).

  Up to 28 days after second vaccination

• Treatment-emergent, clinically significant 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).

  Post-vaccination - 28 days after second vaccination

• Treatment-emergent, clinically significant 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).

  Post-vaccination - 28 days after second vaccination

• Treatment-emergent, clinically significant 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).

  Post-vaccination - 28 days after second vaccination

• Treatment-emergent, clinically significant 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).

  Post-vaccination - 28 days after second vaccination

• Treatment-emergent, clinically significant changes in 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. 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).

  Post-vaccination - 28 days after second vaccination

Secondary Outcomes (16)

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

  28 days - 1 year after second vaccination

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

  28 days - 1 year after second vaccination

• Incidence of SAEs

  28 days - 1 year after second vaccination

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

  on 7, 14 and 28 days after second vaccination

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

  on 7, 14 and 28 days after second vaccination

Study Arms (2)

25 μg Baiya SARS-CoV-2 Vax 2

EXPERIMENTAL

Experimental: 25 μg Baiya SARS-CoV-2 Vax 2, Adult Participants 2 doses of Baiya SARS-CoV-2 Vax 2 (25 μg), each on Day 1 and Day 22 for adult participants (18 - 64 years old)

Biological: 25 Baiya SARS-CoV-2 Vax 2

50 μg Baiya SARS-CoV-2 Vax 2

EXPERIMENTAL

Experimental: 50 μg Baiya SARS-CoV-2 Vax 2, Adult Participants 2 doses of Baiya SARS-CoV-2 Vax 2 (50 μg), each on Day 1 and Day 22 for adult participants (18 - 64 years old)

Biological: 50 Baiya SARS-CoV-2 Vax 2

Interventions

25 Baiya SARS-CoV-2 Vax 2 BIOLOGICAL

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)

25 μg Baiya SARS-CoV-2 Vax 2

50 Baiya SARS-CoV-2 Vax 2 BIOLOGICAL

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)

50 μg Baiya SARS-CoV-2 Vax 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy man or woman between 18 to 64 years old (inclusive).
• Give informed consent prior to study enrolment and all study procedures.
• Participant 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.
• 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 childbearing potential must not be pregnant or breastfeeding.
• 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 90 to 160 millimetres of mercury (mmHg), inclusive, at Screening.
• Participants must agree to refrain from donating blood, plasma, ovules, or sperm during the whole study.
• 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.
• 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.
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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 doing 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.
• 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 more blood sampling.
• Participant is unwilling to abstain from donating plasma, ovules, sperm, or organs during the study.

Sponsors & Collaborators

• Baiya Phytopharm Co., Ltd.: lead
• National Vaccine Institute, Thailand: collaborator

Study Sites (1)

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: January 19, 2022
• Study Start: March 28, 2022
• Primary Completion: May 29, 2023
• Study Completion: April 10, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)