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

NCT04953078 | Completed Phase 1 DMC

• 1 other identifier: PT-CR-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronavirus

Keywords

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

Outcome Measures

Primary Outcomes (17)

• Frequency and Grade of Solicited Adverse Events

  7 days after each vaccination

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

  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)

  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).

  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).

  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).

  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)

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  Up to 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

  Up to 28 days after second vaccination

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

  Up to 28 days after second vaccination

Study Arms (6)

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)

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)

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)

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)

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)

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)

Biological: Baiya SARS-CoV-2 Vax 1

Interventions

Baiya SARS-CoV-2 Vax 1 BIOLOGICAL

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)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

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 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

Sponsors & Collaborators

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

Study Sites (2)

Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Baiya SARS-CoV-2 VAX COVID-19 vaccine

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 7, 2021
• Study Start: September 11, 2021
• Primary Completion: December 2, 2021
• Study Completion: November 4, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)