A Phase 2, Non-inferiority, Open-label, Randomized Controlled Study to Evaluate the Immunogenicity and Safety of Comvigen (Bivalent) Vaccine as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Approved COVID-19 Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- vital signs
研究概览
简要总结
This study will assess the safety, reactogenicity and immunogenicity of a single dose of Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as a booster among healthy males and non-pregnant females aged 18-64 years after receiving a previous booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. The results of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.
详细描述
This is a phase II, non-inferiority, multicenter randomized open-label trial in which 450 healthy males and non-pregnant females, aged 18-64 years, will be recruited from multi-sites in Thailand. The randomization will be a 2:1 design to receive either Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a single dose of COMVIGEN at 50 ug, as a booster dose, given at 3 months and above after receipt of a previous booster dose of any approved mRNA COVID-19 vaccine. The estimated sample size would also allow a comparison between a booster dose, Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine at 50 ug to Comirnaty, BIVALENT of Pfizer/BNT Bivalent vaccine at 30 ug dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Participants who meet all the following criteria at Screening are eligible to participate in the study:
- •Must be a male or female aged 18 - 64 (inclusive) at the time of enrolment
- •Must have completed at least a primary course of 2 doses of any approved COVID-19 vaccine which the last dose have to be mRNA vaccine and completed the last doser 3 months or more
- •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 child-bearing potential, the participants and their partner must use an acceptable, highly effective, double-barrier contraceptive method* from Screening and for a period of at least 60 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 (WOCBP): she agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 12 weeks 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
- •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
- •Participants who meet any of the following criteria are not eligible to participate in the study:
- •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) after 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.
结局指标
主要结局
vital signs
时间窗: 169 days
Number of participants with abnormal vital signs
New Onset Chronic Medical Condition (NOCMCs)
时间窗: 169 days
Presence of New Onset Chronic Medical Condition (NOCMCs) from day 1 to Day 169
solicited injection site or systemic reactions
时间窗: within 7 days after vaccination
Presence of solicited injection site or systemic reactions within 7 days after vaccination
unsolicited adverse events
时间窗: within 28 days after vaccination
Presence of unsolicited adverse events within 28 days after vaccination
adverse events
时间窗: 30 minutes after vaccination
Presence of immediate adverse events within 30 minutes after vaccination
serious adverse events (SAEs)
时间窗: 169 days
Presence of serious adverse events (SAEs) from day 1 to Day 169
medically attended adverse events (MAAEs)
时间窗: 169 days
Presence of medically attended adverse events (MAAEs) from day 1 to Day 169
clinical changes
时间窗: 169 days
Number of participants with abnormal physical examinations finding
Geometric mean titers of neutralizing antibody titer
时间窗: Day 29
Geometric mean titers of neutralizing antibody titer measured by pseudoviral neutralization assay (psVNT-50) against Omicron BA.4/BA.5 exposed to COMVIGEN (Bivalent) vaccine
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer
时间窗: Day 29
Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer against wild-type virus exposed to COMVIGEN (Bivalent) vaccine
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer
时间窗: Day 29
Proportion of participants with at least 4-fold-rise in neutralizing antibody titer, psVNT-50 against wild-type virus exposed to COMVIGEN (Bivalent)
次要结局
- Proportion of participants with at least 4-fold-rise in neutralization antibody titer(Day 29)
- Geometric mean of the fold-rise post-vaccination of anti-RBD antibody(Day 29)
- Geometric mean of the fold-rise post-vaccination of psVNT-50 neutralizing antibody titer(Day 29)
- Geometric mean of the fold-rise post-vaccination of anti-S antibody titer(Day 29)
- Geometric mean of SARS-CoV2-specific T-cell responses(Day 29)
- median number of SARS-CoV2-specific T-cell responses(Day 29)
- Geometric mean titers of anti-RBD antibody titer(Day 29)
- Geometric mean titers of anti-Spike (S) antibody titer(Day 29)
- Geometric mean of the fold-rise post-vaccination of SARS-CoV2-specific T-cell responses(Day 29)
- Geometric mean of the fold-rise post-vaccination of micro-VNT-50(Day 29)
- Proportion of participants with at least 4-fold-rise in micro-VNT-50(Day 29)
- Proportion of participants with at least 4-fold-rise in anti-RBD(Day 29)
- Geometric mean titers of neutralizing antibody titer(Day 29)