Evaluation of Safety, Tolerability, Reactogenicity, Immunogenicity of Baiya SARS-CoV-2 Vax 2 as a Booster for COVID-19

NCT05873374 | Unknown Phase 2 DMC

• 1 other identifier: Baiya-Vax2-P2a-Boost
• Study Type: interventional
• Target: 75
• 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 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.

Conditions

COVID-19 Vaccine; COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Number, percentage, and severity of solicited local and systemic reactogenicity AEs

  7-day post administration

• Number, percentage, and severity of unsolicited AEs

  Day 1 to 28 days after administration

• Number, percentage, and severity of treatment-related AEs

  Day 1 to 28 days after administration

• Abnormal clinically significant changes in clinical laboratory tests (haematology, coagulation, chemistry, and urinalysis)

  Day 1 to 28 days after administration

• Abnormal clinically significant changes in vital signs

  Day 1 to 28 days after administration

• Abnormal clinically significant physical examination

  Day 1 to 28 days after administration

Secondary Outcomes (17)

• Geometric Mean Titres (GMT) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)

  at 7, 14, 21 and 28 days after administration

• Geometric Mean Fold Rises (GMFR) of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)

  at 7, 14, 21 and 28 days after administration

• Seroconversion Rate of SARS-CoV-2 specific serum neutralizing antibody (MicroVNT)

  at 7, 14, 21 and 28 days after administration

• GMT of SARS-CoV-2-surrogate viral neutralising antibody

  at 7, 14, 21 and 28 days after administration

• GMFR of SARS-CoV-2-surrogate viral neutralising antibody

  at 7, 14, 21 and 28 days after administration

Study Arms (2)

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)

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)

Other: Placebo

Interventions

50 μg Baiya SARS-CoV-2 Vax 2 BIOLOGICAL

Intramuscular injection in the deltoid region of 0.5 mL/dose of 50 μg Baiya SARS-CoV-2 Vax 2

50 μg Baiya SARS-CoV-2 Vax 2

Placebo OTHER

Intramuscular injection in the deltoid region of 0.5 mL/dose of 0.9% Sodium Chloride

Also known as: 0.9% Sodium Chloride

Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baiya Phytopharm Co., Ltd.: lead

Study Sites (1)

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Peepattra Wantanasiri, Ph.D.

CONTACT

662-115-9860; peepattra.w@baiyaphytopharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treatment will be masked to the participants and site staff (including the investigators and the care providers which are blinded site staff).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: May 24, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)