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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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)
干预措施: ChulaCov19 BNA159 vaccine (50 mcg) (Biological)
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)
干预措施: Pfizer/BNT vaccine (30 mcg) (Biological)
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)
干预措施: COMVIGEN (ChulaCov19 BNA159.2) vaccine (50 mcg) (Biological)
结局指标
主要结局
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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)