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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05605470




Registration number
NCT05605470
Ethics application status
Date submitted
30/10/2022
Date registered
4/11/2022

Titles & IDs
Public title
Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults
Scientific 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
Secondary ID [1] 0 0
TVL-ChulaVac005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19, SARS CoV 2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ChulaCov19 BNA159 vaccine (50 mcg)
Treatment: Other - Pfizer/BNT vaccine (30 mcg)
Treatment: Other - COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)

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)

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)

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)


Treatment: Other: ChulaCov19 BNA159 vaccine (50 mcg)
Single dose of ChulaCov19 BNA159 vaccine 0.5 ml will be given by IM at Day 1

Treatment: Other: Pfizer/BNT vaccine (30 mcg)
Single dose of Pfizer/BNT vaccine 0.3 ml will be given by IM at Day 1

Treatment: Other: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)
Single dose of COMVIGEN vaccine 0.5 ml will be given by IM at Day 1
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and Part B: Numbers and percentage of participants with immediate adverse events
Timepoint [1] 0 0
within 30 minutes post vaccination
Primary outcome [2] 0 0
Part A and Part B: Numbers and percentage of participants with solicited local or systemic reactions
Timepoint [2] 0 0
within 7-day post-vaccination
Primary outcome [3] 0 0
Part A and Part B: Numbers and percentage of participants with adverse events (AEs)
Timepoint [3] 0 0
28-day post-vaccination
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
6 months post-vaccination
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline, 28-day post-vaccination
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline, 28-day post-vaccination
Primary outcome [7] 0 0
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
Timepoint [7] 0 0
28 days post-vaccination.
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline, 28-day post-vaccination
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline, 28-day post-vaccination
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
28-day post-vaccination
Secondary outcome [4] 0 0
GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type
Timepoint [4] 0 0
Baseline, 28-day post-vaccination
Secondary outcome [5] 0 0
GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type
Timepoint [5] 0 0
Baseline to 28 days post-vaccination.
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
28 days post-vaccination
Secondary outcome [7] 0 0
GMTs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
Timepoint [7] 0 0
Baseline and 28 days post-vaccination.
Secondary outcome [8] 0 0
GMFRs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
Timepoint [8] 0 0
Baseline to 28 days post-vaccination.
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
28 days post-vaccination
Secondary outcome [10] 0 0
Geometric mean (GM) and/or median number of SARS-CoV2-specific T-cell responses (spot-forming cells (SFC) per 1 million PBMCs) measured by IFN?-ELISpot assay against wild-type peptides
Timepoint [10] 0 0
Baseline and 28 days post-vaccination.
Secondary outcome [11] 0 0
GMFRs of number of SFC per 1 million PBMCs measured by IFN?-ELISpot assay against wild-type peptides
Timepoint [11] 0 0
Baseline to 28 days post-vaccination.
Secondary outcome [12] 0 0
GM and/or median number of % Spike specific CD4 and CD8 T-cells as measured by Intracellular Cytokine Staining (ICS) assay
Timepoint [12] 0 0
Baseline and 28 days post-vaccination
Secondary outcome [13] 0 0
GMFR of % Spike-specific CD4 and CD8 T-cells as measured by ICS assay
Timepoint [13] 0 0
Baseline to 28 days post-vaccination.
Secondary outcome [14] 0 0
GM and/or median number of Th1/Th2 ratio as measured by ICS assay
Timepoint [14] 0 0
Baseline and 28 days post-vaccination

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Paratus research Canberra Clinic - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
The Children's Hospital at Westmead Sydney - Westmead
Recruitment hospital [5] 0 0
Paratus Clinical Research- Brisbane Clinic - Albion
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4010 - Albion

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Technovalia, Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Chulalongkorn University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
BioNet-Asia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Southern Star Research Pty Ltd.
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kiat Ruxrunghtam, MD
Address 0 0
Chulalongkorn University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05605470