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

April 9, 2025 updated by: Technovalia, Pty Ltd

A Phase 2 Study to Evaluate the Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Authorized/Approved COVID-19 Vaccine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • Paratus research Canberra Clinic
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Paratus Clinical Research Western Sydney
      • Kanwal, New South Wales, Australia, 2259
        • Paratus Clinical Research Central Coast
      • Westmead, New South Wales, Australia, 2145
        • The Children's Hospital at Westmead Sydney
    • Queensland
      • Albion, Queensland, Australia, 4010
        • Paratus Clinical Research- Brisbane Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
Biological: ChulaCov19 BNA159 vaccine (50 mcg)
Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1
Active Comparator: 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)
Biological: Pfizer/BNT vaccine (30 mcg)
Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1
Experimental: 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)
Biological: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)
Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A and Part B: Numbers and percentage of participants with immediate adverse events
Time Frame: within 30 minutes post vaccination
Numbers and percentage of participants who have had immediate post-immunization reactions within 30 minutes post- vaccination
within 30 minutes post vaccination
Part A and Part B: Numbers and percentage of participants with solicited local or systemic reactions
Time Frame: within 7-day post-vaccination
Numbers and percentage of participants who have had solicited local or systemic reactions within 7-day post-vaccination
within 7-day post-vaccination
Part A and Part B: Numbers and percentage of participants with adverse events (AEs)
Time Frame: 28-day post-vaccination
Numbers and percentage of participants who have had adverse events (AEs) within 28-day post-vaccination
28-day post-vaccination
Part A and Part B:Numbers and percentage of participants with serious adverse events (SAEs), medically attended adverse events (MAAEs) and New Onset Chronic Medical Condition (NOCMCs)
Time Frame: 6 months post-vaccination
Numbers and percentage of participants who have had SAEs, MAAEs, NOCMCs within 6 months post-vaccination
6 months post-vaccination
Geometric mean titres (GMTs) of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against wild type and/or Omicron BA.4/BA.5
Time Frame: Baseline, 28-day post-vaccination
GMTs and their 95%CI of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against wild type (Part A and B) and/or Omicron BA.4/BA.5 (Part B) will be reported at baseline (before vaccination) and 28 days post-vaccination.
Baseline, 28-day post-vaccination
Geometric mean fold rises (GMFRs) of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against wild type and/or Omicron BA.4/BA.5
Time Frame: Baseline, 28-day post-vaccination
GMFRs and their 95%CI of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against wild type (Part A and B) and/or Omicron BA.4/BA.5 (Part B) will be reported from baseline to 28 days post-vaccination.
Baseline, 28-day post-vaccination
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against wild type and/or Omicron BA.4/BA.5
Time Frame: 28 days post-vaccination.
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against wild type (Part A and B) and/or Omicron BA.4/BA.5 (Part B) will be reported at 28 days post-vaccination.
28 days post-vaccination.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against Omicron BA.4/BA.5 and/or other clinically relevant variants of concerns (VOCs)
Time Frame: Baseline, 28-day post-vaccination
GMTs and their 95%CI of SARS-CoV-2-specific serum neutralising antibody as measured by psVNT-50 against Omicron BA.4/BA.5 (Part A) and/or other clinically relevant VOCs (Part A and B) will be reported at baseline (before vaccination) and 28 days post-vaccination.
Baseline, 28-day post-vaccination
GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against Omicron BA.4/BA.5 and/or other clinically relevant VOCs
Time Frame: Baseline, 28-day post-vaccination
GMFR and their 95%CI of SARS-CoV-2-specific serum neutralising titres as measured by psVNT-50 against Omicron BA.4/BA.5 (Part A) and/or other clinically relevant VOCs (Part A and B) will be reported from baseline to 28 days post-vaccination.
Baseline, 28-day post-vaccination
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against Omicron BA.4/BA.5 and/or other clinically relevant VOCs
Time Frame: 28-day post-vaccination
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by psVNT-50 against Omicron BA.4/BA.5 (Part A) and/or other clinically relevant VOCs (Part A and B) will be reported at 28 days post-vaccination.
28-day post-vaccination
GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type
Time Frame: Baseline, 28-day post-vaccination
Part A and Part B: GMTs and their 95%CI of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type will be reported at baseline (before vaccination) and 28 days post-vaccination.
Baseline, 28-day post-vaccination
GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type
Time Frame: Baseline to 28 days post-vaccination.
Part A and Part B: GMFR and their 95%CI of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type will be reported from baseline to 28 days post-vaccination.
Baseline to 28 days post-vaccination.
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by MicroVNT-50 against wild type
Time Frame: 28 days post-vaccination
Part A and Part B: Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV-2-specific serum neutralising antibody titres as measured by MicroVNT-50 against wild type will be reported at 28 days post-vaccination.
28 days post-vaccination
GMTs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
Time Frame: Baseline and 28 days post-vaccination.
GMTs and their 95%CI of anti-RBD and anti-S IgG antibodies as measured by ELISA against wild type (Part A and B) and Omicron (Part B) will be reported at baseline (before vaccination) and 28 days post-vaccination.
Baseline and 28 days post-vaccination.
GMFRs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
Time Frame: Baseline to 28 days post-vaccination.
GMFR and their 95%CI of anti-RBD and anti-S IgG antibodies as measured by ELISA against wild type (Part A and B) and Omicron (Part B) will be reported from baseline to 28 days post-vaccination.
Baseline to 28 days post-vaccination.
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
Time Frame: 28 days post-vaccination
Percentage of participants who achieved a greater than or equal to 4-fold rise from before vaccination of anti-RBD and anti-S IgG antibodies as measured by ELISA against wild type (Part A and B) and Omicron (Part B) will be reported at 28 days post-vaccination
28 days post-vaccination
Geometric mean (GM) and/or median number of SARS-CoV2-specific T-cell responses (spot-forming cells (SFC) per 1 million PBMCs) measured by IFNγ-ELISpot assay against wild-type peptides
Time Frame: Baseline and 28 days post-vaccination.
Part A and Part B: GM and/or median number of SFC per 1 million PBMCs measured by IFNγ-ELISpot assay against wild-type peptides will be reported at baseline (before vaccination) and 28 days post-vaccination
Baseline and 28 days post-vaccination.
GMFRs of number of SFC per 1 million PBMCs measured by IFNγ-ELISpot assay against wild-type peptides
Time Frame: Baseline to 28 days post-vaccination.
Part A and Part B: GMFR and their 95%CI of number of SFC per 1 million PBMCs measured by IFNγ-ELISpot assay against wild-type peptides will be reported from baseline to 28 days post-vaccination.
Baseline to 28 days post-vaccination.
GM and/or median number of % Spike specific CD4 and CD8 T-cells as measured by Intracellular Cytokine Staining (ICS) assay
Time Frame: Baseline and 28 days post-vaccination
Part A and Part B: GM and/or median number of % Spike specific CD4 and CD8 T-cells as measured by ICS assay (from the first 25 subjects from the ChulaCov19 group, the comparator group and COMVIGEN) will be reported at baseline (before vaccination) and 28 days post-vaccination.
Baseline and 28 days post-vaccination
GMFR of % Spike-specific CD4 and CD8 T-cells as measured by ICS assay
Time Frame: Baseline to 28 days post-vaccination.
Part A and Part B: GMFR of % Spike-specific CD4 and CD8 T-cells as measured by ICS assay (from the first 25 subjects from the ChulaCov19 group, the comparator group and COMVIGEN) will be reported from baseline to 28 days post-vaccination.
Baseline to 28 days post-vaccination.
GM and/or median number of Th1/Th2 ratio as measured by ICS assay
Time Frame: Baseline and 28 days post-vaccination
Part A and Part B: GM and/or median number of Th1/Th2 ratio as measured by ICS assay (from the first 25 subjects from the ChulaCov19 group, the comparator group and COMVIGEN) will be reported at baseline (before vaccination) and 28 days post-vaccination.
Baseline and 28 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technovalia, Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chulalongkorn University
Southern Star Research
BioNet-Asia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kiat Ruxrunghtam, MD, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TVL-ChulaVac005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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