CTRI/2025/09/094477进行中（未招募）3 期
A prospective single-blind randomized phase-III comparative study to evaluate immunogenicity and safety of Biological E’s JN.1-RBD subunit Covid-19 vaccine in 18-80 years old individuals.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
- 试验地点
- 5
- 主要终点
- To assess immunogenic superiority of BE’s JN.1-RBD subunit Covid-19 vaccine against monovalent Corbevax vaccine in terms of GMTs of anti-JN.1 neutralizing antibodies
研究概览
简要总结
This will be a prospective, multicentre, single-blind, randomised, comparative phase III clinical study to evaluate the immunogenicity and safety of a single booster dose of Biological E’s JN.1-RBD subunit vaccine, when administered to individuals 18 to 80 years of age previously vaccinated with any existing COVID-19 vaccine either as primary series or booster dose with the most recent dose at least six months prior to enrolment.
Individuals of stable health aged between 18 to 80 years old adults of either gender that are nasopharyngeal swab SARS-CoV-2 RT-PCR negative at the time of screening will be enrolled.
A total of 270 subjects, aged 18 to 80 years, will be enrolled to either a test group (Group-1) or to a control group (Group-2) for immunogenicity and safety assessment.
The study will be conducted in compliance with New Drugs and Clinical Trials Rules, 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
- Randomized
- 盲法
- Participant 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
- •Subject has the ability to provide written informed consent and does so;
- •Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol;
- •Participants of either gender, aged between 18 to 80 years at the time of vaccination;
- •Participants negative for SARS-CoV-2 infection as assessed by a nasopharygeal swab RT-PCR test prior to enrolment.
- •Participants who have completed primary immunization with any COVID-19 vaccine with atleast 6 months ago
- •Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital sign as defined in the protocol.
- •Subject agrees not to participate in another clinical trial at any time during the total study period.
- •Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
- •Negative urine pregnancy test for female subjects of childbearing potential at screening, has practiced adequate contraception for one month prior to study intervention administration and has agreed to continue adequate contraception during the entire treatment period and for one month after completion of the study intervention administration.
- •Female participants of non-childbearing potential.
- •11.No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
- •Subject willing to allow storage and future use of collected biological samples for future research in an anonymised form.
排除标准
- •Living in the same household as any COVID-19 positive person;
- •Those who have received any COVID-19 vaccine (s) during the last 6 months prior to enrolment
- •Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;
- •History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);
- •Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period
- •Current or planned participation in prophylactic or therapeutic drug trials for the duration of the study.
- •Positive test results of HIV 1 & 2, HBV and HCV infection in participants;
- •Body temperature of greater than 100.4°F (greater than 38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination; 9.History of severe psychiatric conditions likely to affect participation in the study;
- •History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
- •History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s test or control vaccine formulations;
- •Chronic respiratory disease, including asthma;
- •Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
- •Any other serious chronic illness requiring hospital specialist supervision;
- •Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products.
- •For corticosteroids, this will mean prednisolone greater than or equal to 0.5 mg kg day, or equivalent.
- •Inhaled and topical steroids are allowed;
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required);
- •Any medical condition that in the judgment of the investigator would make study participation unsafe.
- •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
To assess immunogenic superiority of BE’s JN.1-RBD subunit Covid-19 vaccine against monovalent Corbevax vaccine in terms of GMTs of anti-JN.1 neutralizing antibodies
时间窗: On Day 28 post booster dose
次要结局
- Occurrence of any adverse reactions(Within 60 minutes of immediate post booster vaccination)
- Occurrence of any solicited local and systemic adverse events(Within 7 consecutive days after booster vaccination)
- Occurrence of any unsolicited adverse events (AEs), serious AEs (SAEs), medically attended AEs (MAAEs) or AEs of special interest (AESIs)(Until 28 days’ post booster vaccination)
- To assess geometric mean concentration (GMC) of anti-JN.1-RBD-IgG and GMTs of PSVNT antibodies(at baseline and on Day 28 in both test (Group-1) and control (Group-2) groups)
- To assess geometric mean fold rise (GMFR) in Anti-JN.1 RBD-IgG and PSVNT antibodies(At Day 28 from baseline)
- Proportion of subjects with greater than or equal to 2- fold and greater than or equal to 4-fold rise in anti-JN.1 neutralizing antibody (nAb) titers(At day 28 post vaccination)
- Proportion of subjects with greater than or equal to 2- fold and greater than or equal to 4-fold rise in anti-JN.1-RBD Ig G antibody concentration/titers(At day 28 post vaccination.)
研究者
Dr Subhash Thuluva
Biological E.Limited
研究点 (5)
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