AzTrials
AzTrials

COVID-19, SARS CoV 2 InfectionPhase 2NCT05605470

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

A Phase 2 study testing ChulaCov19 BNA159 vaccine (50 mcg), Pfizer/BNT vaccine (30 mcg) and COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg) in people with COVID-19, SARS CoV 2 Infection, run by Technovalia, Pty Ltd at 5 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS CoV 2 Infection
What is being tested?
ChulaCov19 BNA159 vaccine (50 mcg), Pfizer/BNT vaccine (30 mcg) and COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
5 sitesAustralia
Study dates
19 Jan 2023to 18 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment
  • 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
  • Must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements
  • Participants must sign the written informed consent form prior to undertaking any protocol-related procedures
  • SARS-CoV-2 rapid antigen test is negative at Day 1 (the day of receiving the study booster dose)
  • 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
Show all 12Show fewer
  • 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
  • A female participant is eligible if she is not pregnant, or breastfeeding indicated by one of the following conditions:
  • 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
  • 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.
  • Participants must be in general good health* based on medical history and physical examination, as determined by the PI at Screening.
  • Participants must agree to refrain from donating blood, plasma, ova, sperm, or organs during the whole study.

Who cannot join

  • History of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances.
  • History of test-confirmed by PCR or rapid antigen test to SARS-CoV-2 COVID-19 infection within 3 months prior to randomisation.
  • 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
  • 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.
  • Presence of an acute illness* or with fever at 38.00 C or more within 72 hours prior to vaccination.
  • Bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on Investigator's judgment
Show all 12Show fewer
  • Inadequate venous access to allow the collection of blood samples.
  • 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.
  • History of ever had an anaphylaxis reaction to food, medication, or vaccination.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Paratus Clinical Research- Brisbane Clinic

    Albion, Queensland, 4010

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2148

  • Paratus research Canberra Clinic

    Bruce, Australian Capital Territory, 2617

  • Paratus Clinical Research Central Coast

    Kanwal, New South Wales, 2259

  • The Children's Hospital at Westmead Sydney

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
ChulaCov19 BNA159 vaccine (50 mcg), Pfizer/BNT vaccine (30 mcg), COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChulaCov19 BNA159 vaccine (50 mcg)Biological

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

  • Pfizer/BNT vaccine (30 mcg)Biological

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

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

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

Study groups in NCT05605470
Study groupRoleWhat they receive
Part A: Arm 1 (1 dose of ChulaCov19 BNA159 vaccine)ExperimentalParticipants will be randomized to receive ChulaCov19 BNA159 vaccine (50 mcg) given by IM (n=55)
Receives: Biological: ChulaCov19 BNA159 vaccine (50 mcg)
Part A: Arm 2 (one dose of active comparator vaccine)Active comparatorParticipants will be randomized to receive Comirnaty® (Pfizer/BNT) vaccine (30 mcg) given by IM (n=25)
Receives: Biological: Pfizer/BNT vaccine (30 mcg)
Part B: Arm 3 (one dose of COMVIGEN vaccine)ExperimentalParticipants will be randomized to receive ChulaCov19 BNA159.2 (COMVIGEN) vaccine (50 mcg) given by IM (n=70)
Receives: Biological: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A and Part B: Numbers and percentage of participants with immediate adverse events

    Numbers and percentage of participants who have had immediate post-immunization reactions within 30 minutes post- vaccination

    Measured: within 30 minutes post vaccination

  2. Part A and Part B: Numbers and percentage of participants with solicited local or systemic reactions

    Numbers and percentage of participants who have had solicited local or systemic reactions within 7-day post-vaccination

    Measured: within 7-day post-vaccination

  3. Part A and Part B: Numbers and percentage of participants with adverse events (AEs)

    Numbers and percentage of participants who have had adverse events (AEs) within 28-day post-vaccination

    Measured: 28-day post-vaccination

  4. 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)

    Numbers and percentage of participants who have had SAEs, MAAEs, NOCMCs within 6 months post-vaccination

    Measured: 6 months post-vaccination

  5. 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

    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.

    Measured: Baseline, 28-day post-vaccination

  6. 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

    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.

    Measured: Baseline, 28-day post-vaccination

  7. 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

    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.

    Measured: 28 days post-vaccination.

Secondary outcomes (14)

  1. 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)

    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.

    Measured: Baseline, 28-day post-vaccination

  2. 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

    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.

    Measured: Baseline, 28-day post-vaccination

  3. 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

    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.

    Measured: 28-day post-vaccination

  4. GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type

    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.

    Measured: Baseline, 28-day post-vaccination

  5. GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type

    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.

    Measured: Baseline to 28 days post-vaccination.

  6. 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

    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.

    Measured: 28 days post-vaccination

  7. GMTs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.

    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.

    Measured: Baseline and 28 days post-vaccination.

  8. GMFRs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.

    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.

    Measured: Baseline to 28 days post-vaccination.

  9. 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.

    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

    Measured: 28 days post-vaccination

  10. 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

    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

    Measured: Baseline and 28 days post-vaccination.

  11. GMFRs of number of SFC per 1 million PBMCs measured by IFNγ-ELISpot assay against wild-type peptides

    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.

    Measured: Baseline to 28 days post-vaccination.

  12. GM and/or median number of % Spike specific CD4 and CD8 T-cells as measured by Intracellular Cytokine Staining (ICS) assay

    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.

    Measured: Baseline and 28 days post-vaccination

  13. GMFR of % Spike-specific CD4 and CD8 T-cells as measured by ICS assay

    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.

    Measured: Baseline to 28 days post-vaccination.

  14. GM and/or median number of Th1/Th2 ratio as measured by ICS assay

    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.

    Measured: Baseline and 28 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start19 Jan 2023
  3. Primary completion15 Jul 2024
  4. Study completion18 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605470
Sponsor's protocol ID
TVL-ChulaVac005
Status last verified
Nov 2024
First submitted
30 Oct 2022
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ChulaCov19 BNA159 vaccine (50 mcg), Pfizer/BNT vaccine (30 mcg) and COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg) in people with COVID-19, SARS CoV 2 Infection, run by Technovalia, Pty Ltd at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and Part B: Numbers and percentage of participants with immediate adverse events (time frame: within 30 minutes post vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in