A Prospective, Multi-centre, Open-labelled, Randomized, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of GEMCOVAC-OM as a booster in Subjects 18 years of age and older
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 3,280
- 试验地点
- 21
- 主要终点
- Phase II
研究概览
简要总结
This is a Phase II study seamlessly followed by Phase III study to evaluate the immunogenicity and safety of a booster dose of the mRNA vaccine – GEMCOVAC-OM. The study participants will be adult subjects who are fully vaccinated against COVID-19 with either COVAXIN™ or COVISHIELD™ and received last dose of primary vaccination at least 4 months prior to screening. This booster dose of GEMCOVAC-OM is based on the sequence of Omicron variant of SARS-CoV-2. The study will be conducted in two parts:
Phase II
Approximately 140 subjects will be randomized in 1:1 ratio to receive either booster dose of the mRNA vaccine GEMCOVAC-OM (intradermal) or a booster dose of GEMCOVAC-19 (intramuscular).
Phase III
Approximately 3140 subjects will be randomized, and the enrolment will be competitive. The subjects will be randomized into two arms:
Arm I: 3000 Subjects who have received either COVAXINâ„¢ or COVISHIELDâ„¢ as primary vaccination (both doses) will receive a booster dose of GEMCOVAC-OM.
Arm II: 140 Subjects who have received COVISHIELDâ„¢ as primary vaccination (both doses) will receive a booster dose of COVISHIELDâ„¢.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female aged greater than or equal to 18 years
- •Subject who had received primary vaccination (both doses completed) with either a.
- •COVAXINâ„¢ OR b.
- •COVISHIELDâ„¢ Wherein last dose of primary vaccination taken at least 4 months prior to the screening visit
- •Subject or their legally acceptable representative (LAR) should be capable and willing to give voluntary written informed consent prior to inclusion in the study
- •Inclusion of subjects based on clinical judgment by the investigator
- •Subjects who had COVID-19 infection after primary vaccination, should have been asymptomatic or RT-PCR negative for at least 3 months
- •Consent for using effective methods of contraception during the entire study period
- •No medical history of pronounced vaccine-induced reactions or complications after receiving immunobiological products
- •No acute infectious and/or respiratory diseases within 14 days prior to screening
- •Subjects able to comprehend and comply with study requirements and procedures and willing to complete subject diary.
排除标准
- •Prior receipt of any COVID-19 vaccine in less than 4 months of duration
- •Pregnant or lactating mothers
- •Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
- •History of chronic infections in immunocompromised subjects
- •Subjects with oncological disease within 5 years prior to inclusion into the study
- •History of the human immunodeficiency virus, syphilis, hepatitis B, or C
- •Acute Kidney injury or dialysis, had transplant and on immunosuppressive therapy
- •Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements
- •Receipt of steroids and/or immunoglobulins or other blood products within 30 days prior to randomization
- •Tattoos or scars at the injection site, which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration
- •Participation in other interventional clinical trial within the previous 90 days prior to randomization and over duration of the trial
- •Any other condition that the study physician considers as a barrier to the trial completion as per the protocol.
结局指标
主要结局
Phase II
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Immunogenicity:
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Comparison of anti-Spike IgG Antibodies
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Safety:
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Occurrence and severity of local and systemic reactogenicity AE
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Occurrence of unsolicited AE
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Occurrence of related unsolicited related AE
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Occurrence of SAE
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Phase III
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Comparison of neutralizing antibody titers against SARS-CoV-2 using PRNT assay by non-inferiority
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
Comparison of seroconversion rates as assessed by greater than or equal to 2-fold rise in neutralizing antibodies using PRNT assay
时间窗: Phase II | Immunogenicity: Day 29 | Safety: | Day 7 (Local and Systemic reactogenicity) | Day 29 (Unsolicited AE) | Day 180 (SAE and related unsolicited AE throughout the duration of the study) | Phase III | Immunogenicity: Day 29
次要结局
- Phase II(Immunogenicity:)
- Phase III(Immunogenicity:)