CTRI/2022/01/039366已完成3 期
A Prospective double-blind randomised Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Single Booster dose of Biological E’s CORBEVAX vaccine when Administered to COVID-19-Negative Adult Volunteers Previously vaccinated with 2-doses of either Covishield or Covaxin.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 7
- 主要终点
- Proportion of subjects achieving ≥2-fold increase in neutralizing antibodies after single booster dose of Corbevax
研究概览
简要总结
This is a prospective, multicentre, double-blind, randomised phase III clinical study to evaluate the immunogenicity and safety of single booster dose of Biological E’s CORBEVAX vaccine, when administered to equal number of healthy and high risk or comorbid condition participants who are between 18 to 80 years of age previously vaccinated with 2-doses of either Covishield and Covaxin, with the most recent dose at least six months (+28 days time window) prior to enrolment in sub group-1 and at least 9 months (+28 days time window) prior to enrolment in subgroup-2 under each treatment arm/group.
Subjects must be RT-PCR negative to SARS-CoV-2 from nasopharyngeal sample prior to enrolment. A total of 416 subjects between 18 to 80 years of age, will be enrolled into the study.
All eligible subjects will be randomised by treatment planned and by age into respective arms.
The study will be conducted in compliance with GSR 227(E), ICH and Indian good clinical practice guidelines in force at the time of study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy and/or high risk individuals of either gender between 18 to 80 years of age at enrolment;
- •Have received two doses of Covishield OR two doses of Covaxin, with the most recent dose at least six or nine months prior to enrolment;
- •Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study;
- •Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol;
- •Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment;
- •Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination;
- •Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study;
- •Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period.
- •Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration;
- •Subject agrees not to participate in another clinical trial at any time during the total study period;
- •Subject agrees to refrain from blood donation during the course of the study;
- •Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
排除标准
- •Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment;
- •Have previously already received one or two doses of any COVID-19 vaccine except Covishield or Covaxin;
- •Pregnant women, nursing women or women of childbearing potential who are or may not actively avoid pregnancy during the study period;
- •Hospitalized patients, patients who need intensive care and/or require a ventilator to help them breathe;
- •Subjects with body temperature of ≥100.4°F (>38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination;
- •Subjects with history of Covid-19 infection after receiving primary vaccination.
- •Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: a)Severe psychiatric conditions; b)Any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder); c)Allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE’s CORBEVAX vaccine);
- •Individuals who report any medical condition, or as determined by a clinician, not suitable to receive protein based subunit COVID-19 vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine.
- •Neurological illness, and any other serious chronic illness requiring hospital specialist supervision.
- •Use of medication that impairs immune system in the last 6 months, except topical or inhaled steroids or short-term oral steroids (course lasting ≤14 days).
- •Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data.
- •Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment.
- •Current or planned participation in prophylactic drug trials for the duration of the study.
- •Individuals who are part of the study team or close family members of individuals conducting the study.
结局指标
主要结局
Proportion of subjects achieving ≥2-fold increase in neutralizing antibodies after single booster dose of Corbevax
时间窗: At day 28
次要结局
- Proportion of subjects with solicited adverse reactions/symptoms(during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days)
- Proportion of subjects with unsolicited adverse events (AEs)(during the first 28 days and for further 6 and 9 months of safety follow up period)
- Serious adverse events (SAEs), if any,(during the entire study period.)
- Medically attended adverse events (MAAE), and adverse events of special interest (AESI)(during the entire study period.)
- Geometric mean titre (GMT/C) of neutralising antibodies in both groups(28 days after single booster dose.)
- GMC/T of anti-RBD IgG antibodies(at pre-booster and 28 days after booster)
- GMFR in comparison to pre booster(28 days after booster)
- Persistance of anti-SARS-CoV-2 IgG antibodies and virus neutralising antibodies (VNA) in terms of their geometric mean titres (GMT/C)(at 6 months post single booster dose in comparison with corresponding antibody levels and day 28 post booster dose.)
研究者
研究点 (7)
Loading locations...
相似试验
终止
3 期
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine TumoursNeuroendocrine Tumors in LungNCT02683941Ipsen77
招募中
3 期
A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell LymphomaNCT06776952Evopoint Biosciences Inc.120
招募中
3 期
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)Chronic Myelomonocytic LeukemiaNCT06647862ImmuneOnco Biopharmaceuticals (Shanghai) Inc.170
Unknown
3 期
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung CancerAdvanced Non-squamous Cell Non-small Cell Lung CancerNCT04439890Chia Tai Tianqing Pharmaceutical Group Co., Ltd.369
已完成
3 期
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)Clostridium Difficile Infection (CDI)NCT03244644Rebiotix Inc.320