Clinical trial NCT05605470: Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19, SARS CoV 2 Infection
Lead sponsor: Technovalia, Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Chulalongkorn University
name: BioNet-Asia
name: Southern Star Research
First posted: 2022-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Part A and Part B: Numbers and percentage of participants with immediate adverse events
timeFrame: within 30 minutes post vaccination
measure: Part A and Part B: Numbers and percentage of participants with solicited local or systemic reactions
timeFrame: within 7-day post-vaccination
measure: Part A and Part B: Numbers and percentage of participants with adverse events (AEs)
timeFrame: 28-day post-vaccination
measure: 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)
timeFrame: 6 months post-vaccination
measure: 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
timeFrame: Baseline, 28-day post-vaccination
measure: 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
timeFrame: Baseline, 28-day post-vaccination
measure: 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
timeFrame: 28 days post-vaccination.
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 28-day post-vaccination
measure: 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
timeFrame: Baseline, 28-day post-vaccination
measure: 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
timeFrame: 28-day post-vaccination
measure: GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type
timeFrame: Baseline, 28-day post-vaccination
measure: GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type
timeFrame: Baseline to 28 days post-vaccination.
measure: 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
timeFrame: 28 days post-vaccination
measure: GMTs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
timeFrame: Baseline and 28 days post-vaccination.
measure: GMFRs of SARS-CoV2-RBD-binding (anti-RBD) and Spike-binding (anti-S) IgG antibodies as measured by ELISA against wild type and Omicron.
timeFrame: Baseline to 28 days post-vaccination.
measure: 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.
timeFrame: 28 days post-vaccination
measure: 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
timeFrame: Baseline and 28 days post-vaccination.
measure: GMFRs of number of SFC per 1 million PBMCs measured by IFNγ-ELISpot assay against wild-type peptides
timeFrame: Baseline to 28 days post-vaccination.
measure: GM and/or median number of % Spike specific CD4 and CD8 T-cells as measured by Intracellular Cytokine Staining (ICS) assay
timeFrame: Baseline and 28 days post-vaccination
measure: GMFR of % Spike-specific CD4 and CD8 T-cells as measured by ICS assay
timeFrame: Baseline to 28 days post-vaccination.
measure: GM and/or median number of Th1/Th2 ratio as measured by ICS assay
timeFrame: Baseline and 28 days post-vaccination
Other outcomes:
Locations:
city: Bruce
country: Australia
facility: Paratus research Canberra Clinic
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead Sydney
state: New South Wales
city: Albion
country: Australia
facility: Paratus Clinical Research- Brisbane Clinic
state: Queensland
Study officials:
affiliation: Chulalongkorn University
name: Kiat Ruxrunghtam, MD
role: STUDY_DIRECTOR
References: