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
Overview
- Phase
- Phase 2
- Intervention
- ChulaCov19 BNA159 vaccine (50 mcg)
- Conditions
- COVID-19, SARS CoV 2 Infection
- Sponsor
- Technovalia, Pty Ltd
- Enrollment
- 150
- Locations
- 5
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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
- •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.
Arms & Interventions
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)
Intervention: ChulaCov19 BNA159 vaccine (50 mcg)
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)
Intervention: Pfizer/BNT vaccine (30 mcg)
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)
Intervention: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg)
Outcomes
Primary Outcomes
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
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
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
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
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.
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.
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.
Secondary Outcomes
- 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)(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(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(28-day post-vaccination)
- GMTs of SARS-CoV-2-specific serum neutralising antibody as measured by MicroVNT-50 against wild type(Baseline, 28-day post-vaccination)
- GMFRs of SARS-CoV-2-specific serum neutralising titres as measured by MicroVNT-50 against wild type(Baseline to 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.(Baseline and 28 days post-vaccination.)
- GMFRs of number of SFC per 1 million PBMCs measured by IFNγ-ELISpot assay against wild-type peptides(Baseline to 28 days post-vaccination.)
- GM and/or median number of Th1/Th2 ratio as measured by ICS assay(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.(Baseline to 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(Baseline and 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.(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(Baseline and 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(28 days post-vaccination)
- GMFR of % Spike-specific CD4 and CD8 T-cells as measured by ICS assay(Baseline to 28 days post-vaccination.)