Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults

NCT ID: NCT05605470

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2024-11-18

Brief Summary

This clinical trial is designed to assess the safety, tolerability and immunogenicity of a single dose of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 vaccines as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine.

Detailed Description

This is a phase II, randomised open-label trial in which 150 healthy males and non-pregnant females aged 18-64 years, will be recruited from multi-sites in Australia. This is a 2-part study (Part A and Part B). In Part A, the randomisation will be a 2:1 design to receive either ChulaCov19 BNA159 vaccine or Comirnaty Pfizer/BNT vaccine. In Part B, participants will receive only ChulaCov19 BNA159.2 (Bivalent, COMVIGEN) vaccine. Participants in part A and B will be followed up using a combination of an-site and telephone visits for assessment of safety and immunogenicity for 6 months post-vaccination.

Conditions

COVID-19, SARS CoV 2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Part A: Arm 1 (1 dose of ChulaCov19 BNA159 vaccine)

Participants will be randomized to receive ChulaCov19 BNA159 vaccine (50 mcg) given by IM (n=55)

Group Type: EXPERIMENTAL

ChulaCov19 BNA159 vaccine (50 mcg)

Intervention Type: BIOLOGICAL

Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1

Part A: Arm 2 (one dose of active comparator vaccine)

Participants will be randomized to receive Comirnaty® (Pfizer/BNT) vaccine (30 mcg) given by IM (n=25)

Group Type: ACTIVE_COMPARATOR

Pfizer/BNT vaccine (30 mcg)

Intervention Type: BIOLOGICAL

Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1

Part B: Arm 3 (one dose of COMVIGEN vaccine)

Participants will be randomized to receive ChulaCov19 BNA159.2 (COMVIGEN) vaccine (50 mcg) given by IM (n=70)

Group Type: EXPERIMENTAL

COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)

Intervention Type: BIOLOGICAL

Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1

Interventions

ChulaCov19 BNA159 vaccine (50 mcg)

Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1

Intervention Type: BIOLOGICAL

Pfizer/BNT vaccine (30 mcg)

Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1

Intervention Type: BIOLOGICAL

COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)

Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment

2. Must have completed a primary course of 2 doses of any approved COVID-19 vaccine and 3 months or more have passed since receipt of last booster dose (1 or 2 prior booster doses for a total of 3 or 4 doses) as described in Table 1

3. Must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements

4. Participants must sign the written informed consent form prior to undertaking any protocol-related procedures

5. SARS-CoV-2 rapid antigen test is negative at Day 1 (the day of receiving the study booster dose)

6. Does not intend to receive any other authorized/approved COVID-19 vaccine at the time of enrolment and up to 3 months of the study

7. 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 childbearing potential, the participants and their partner must use an acceptable, highly effective, dual contraceptive method* from Screening and for a period of at least 90 days after vaccination

8. A female participant is eligible if she is not pregnant, or breastfeeding indicated by one of the following conditions:

1. With childbearing potential: she agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 90 days after the study intervention administration, or

2. With non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. If the participant is < 1 year post-menopausal, an FSH test may be conducted to establish childbearing potential.

9. Participants must be in general good health* based on medical history and physical examination, as determined by the PI at Screening.

10. Participants must agree to refrain from donating blood, plasma, ova, sperm, or organs during the whole study.

Exclusion Criteria

1. History of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances.

2. History of test-confirmed by PCR or rapid antigen test to SARS-CoV-2 COVID-19 infection within 3 months prior to randomisation.

3. Presence of clinically significant medical history*, unstable chronic or acute disease that, in the opinion of the PI, may increase the risk of exposure to the investigational vaccine

4. History of having any significant side effects after receipt of any other COVID-19 vaccine eg. endocarditis, pericarditis or myocarditis. History of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine.

5. Presence of an acute illness* or with fever at 38.00 C or more within 72 hours prior to vaccination.

6. Bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on Investigator's judgment

7. Inadequate venous access to allow the collection of blood samples.

8. Received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. For influenza vaccine, however, can be administered up to 14 days prior to randomization and following Visit 3 (Day 29+3) blood sample collection.

9. History of ever had an anaphylaxis reaction to food, medication, or vaccination.

10. Participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents* within the next 6 months.

11. Participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study.

12. Received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: collaborator

BioNet-Asia

UNKNOWN

Sponsor Role: collaborator

Southern Star Research

INDUSTRY

Sponsor Role: collaborator

Technovalia, Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiat Ruxrunghtam, MD

Role: STUDY_DIRECTOR

Chulalongkorn University

Locations

Paratus research Canberra Clinic

Bruce, Australian Capital Territory, Australia

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, Australia

Paratus Clinical Research Central Coast

Kanwal, New South Wales, Australia

The Children's Hospital at Westmead Sydney

Westmead, New South Wales, Australia

Paratus Clinical Research- Brisbane Clinic

Albion, Queensland, Australia

Countries

Australia

Other Identifiers

TVL-ChulaVac005

Identifier Type: -

Identifier Source: org_study_id