Safety and Immunogenicity of ChulaCov19 BNA159 mRNA Vaccine

NCT05231369 | Unknown Phase 1 DMC

• 1 other identifier: ChulaVac 003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1 study that will evaluate the safety and immunogenicity of ChulaCov19 BNA159 mRNA vaccine in healthy adults.

Conditions

Safety of 25 ug of ChulaCov19-BNA159 mRNA Vaccine; Tolerability of 25 ug of ChulaCov19-BNA159 mRNA Vaccine; Immune Response of 25 ug of ChulaCov19-BNA159 mRNA Vaccine; Safety of 50 ug of ChulaCov19-BNA159 mRNA Vaccine; Tolerability of 50 ug of ChulaCov19-BNA159 mRNA Vaccine; Immune Response of 50 ug of ChulaCov19-BNA159 mRNA Vaccine; Assess Which Dose is Appropriate to Use

Outcome Measures

Primary Outcomes (9)

• Frequency of solicited local reactogenicity adverse events (AE)

  Frequency of solicited local reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

  during a 7-day follow-up period post each vaccination (up to Day 29+3)

• Grade of solicited local reactogenicity adverse events (AE)

  Grade of solicited local reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

  during a 7-day follow-up period post each vaccination (up to Day 29+3)

• Frequency of solicited systemic reactogenicity adverse events (AE)

  Frequency of solicited systemic reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

  during a 7-day follow-up period post each vaccination (up to Day 29+3)

• Grade of solicited systemic reactogenicity adverse events (AE)

  Grade of solicited systemic reactogenicity adverse events (AE) during a 7-day follow-up period post each vaccination (up to Day 29+3)

  during a 7-day follow-up period post each vaccination (up to Day 29+3)

• Changes in vital signs

  Changes in vital signs

  up to Visit 9 - Day 29 +3

• Changes in physical examinations

  Changes in physical examinations

  up to Visit 9 - Day 29 +3

• Clinically relevant changes in laboratory measurement

  Clinically relevant changes in laboratory measurement

  up to Visit 9 - Day 29 +3

• Treatment-emergent, clinically significant changes in vital signs

  Treatment-emergent, clinically significant changes in vital signs

  up to Visit 9 - Day 29 +3

• Treatment-emergent, clinically significant changes in physical examinations

  Treatment-emergent, clinically significant changes in physical examinations

  up to Visit 9 - Day 29 +3

Secondary Outcomes (8)

• Frequency of unsolicited AEs

  up to Day 50 ±3

• Grade of unsolicited AEs

  up to Day 50 ±3

• Frequency of SAEs

  up to the end of the study Day387 ±14

• Frequency of MAAEs

  up to the end of the study Day387 ±14

• Frequency of NOCMCs

  up to the end of the study Day387 ±14

Other Outcomes (54)

• Geometric mean titres (GMT)

  at Day 50 (±3)

• Proportion of participants who achieved a greater than or equal to 4-fold rise from before vaccination to Day 50 (±3)

  before vaccination to Day 50 (±3)

• Geometric mean ratio (GMR) defined as GMT ratio between the two doses of ChulaCov19 BNA159 mRNA vaccine

  at Day 50 (±3)

Study Arms (2)

group 1: 25 ug of ChulaCov19 BNA159 mRNA vaccine

EXPERIMENTAL

The participants will receive 25 ug of the vaccine.

Biological: ChulaCov19 BNA159 mRNA vaccine

group 2: 50 ug of ChulaCov19 BNA159 mRNA vaccine

EXPERIMENTAL

If 25 ug is safe, then will proceed to enroll 12 more participants to receive 50 ug.

Biological: ChulaCov19 BNA159 mRNA vaccine

Interventions

ChulaCov19 BNA159 mRNA vaccine BIOLOGICAL

ChulaCov19 BNA159 mRNA vaccine is the lipid nanoparticles (LNPs)-encapsulated mRNA-based ChulaCov19 vaccine

group 1: 25 ug of ChulaCov19 BNA159 mRNA vaccine; group 2: 50 ug of ChulaCov19 BNA159 mRNA vaccine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants between the ages of 18 and 60 years, inclusive, at enrolment
• Women of child-bearing potential (WOCBP) may be enrolled in the study if the participant fulfils all the following criteria:
• Has a negative urine-based pregnancy test at screening and on the day of the first dose (Day1) and second dose (Day22)
• Must practice true abstinence or, if engaged in sexual relations with a male, they must agree to use highly effective (failure rate of \< 1% per year when used consistently and correctly), double-barrier contraceptive measures\* from screening and for a period of at least 60 days after the last dose of investigational vaccine.
• Is not currently breastfeeding.
• Women of non-child-bearing potential may be enrolled in the study if the participant meet one of these following criteria:
• d. Postmenopausal (defined as having a history of amenorrhea of at least one year), or e. History of amenorrhea is less than one year, must have an FSH level \> 40 milli-international units per milliliter (mIU/mL), or f. Have a documented status of being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy).
• Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), practice true abstinence or, if engaged in sexual relations with a female of child-bearing potential, the participants and their partner must use an acceptable, highly effective, double-barrier contraceptive method\* from Screening and for a period of at least 60 days after the last dose of investigational vaccine.
• \* The PI is to assess the adequacy of methods of contraception on a case-by-case basis. These criteria do not apply if the participants are in a same-sex relationship.
• Type of Participant and Disease Characteristics:
• Participants must be able to communicate effectively with study personnel and agree to comply with the study procedures.
• Capable to provide written informed consent.
• Participants must have haematology, clinical chemistry, coagulation and urinalysis test results that are not deviating from the normal reference range by age and gender to a clinically relevant extent at Screening.

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.
• Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Participant has previously participated in an investigational study involving LNPs (a component of the investigational vaccine assessed in this trial).
• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
• Close contact with anyone known to have SARS-CoV-2 infection within 10 days prior to vaccine administration.
• Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
• Uncontrolled hypertension
• Diabetes mellitus
• Cardiovascular disease
• Chronic pulmonary disease
• Asthma
• Chronic liver disease
• Stage 3 or worse chronic kidney disease (glomerular filtration rate \<60 mL/min/1.73 m2)
• BMI \>30 kg/m2

Sponsors & Collaborators

• Chulalongkorn University: lead
• Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University: collaborator
• Academic Clinical Research Office (ACRO), Faculty of Medicine, Khon Kaen University: collaborator
• BioNet-Asia: collaborator

Study Sites (2)

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

Bangkok, 10330, Thailand

RECRUITING

Academic Clinical Research Office (ACRO) Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand

RECRUITING

Study Officials

• Sivaporn Gatechompol, MD

  HIV-NAT, Thai Red Cross - AIDS Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sivaporn Gatechompol, MD

CONTACT

662 652 3040; sivaporn.k@hivnat.org

Study Design

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

Model Details: If 25 ug dose is safe, then will proceed to enroll participants to receive 50 ug.

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 9, 2022
• Study Start: December 14, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

TH (2)