A Phase III, Randomized, Open label, Multicentre Clinical Study in Parallel Assignment to Evaluate Immunogenicity and Safety of a Booster Dose of Sputnik Light Vector Vaccine against COVID-19 in Adult Indian Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 580
- 试验地点
- 8
- 主要终点
- To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of:
研究概览
简要总结
This is a Phase III study to evaluate the immunogenicity and safety of a booster dose of Sputnik Light Vector Vaccine. The study participants will be adult subjects (including those at high risk or with comorbid conditions) who are fully vaccinated against COVID-19 with either Covaxin or Covishield and received last dose of primary vaccination 6 - 7 months prior to screening.
Approximately 580 subjects will be enrolled and the enrolment will be competitive: 290 subjects with Covaxin as primary vaccination and 290 subjects with Covishield as primary vaccination. Subjects in each primary vaccination group will be randomized in 1:1 ratio to receive a booster dose with Sputnik light vector vaccine (heterologous booster) or homologous boosting with their respective primary vaccine.
Thus, Sputnik light Booster Group will include 290 subjects who would have received Covaxin (n=145) or Covishield (n=145) as primary vaccination (both doses).
Whereas Homologous booster Group will include 290 subjects; of which 145
would be Covaxin primed and receive Covaxin as booster and remaining 145
would be Covishield primed and would receive Covishield as booster.
All study subjects will receive 1 booster dose of respective vaccine as per their randomization arm on Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be enrolled in the study if they meet all the following criteria.
- •Male and female aged ≥ 18 years
- •Subject who had recieved primary vaccination (both doses completed) with either a.
- •COVAXIN (Group 1) OR b.
- •COVISHIELD (Group 2) Where last dose of primary vaccination was taken 6-7 months prior to the screening visit
- •Subjects who are determined by medical/surgical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
- •If the subject had COVID-19 after primary vaccination, that subject should have passed 3 months after being asymptomatic or RT-PCR negative
- •Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit
- •Consent for using effective methods of contraception during the entire trial and 3 months after its completion
- •No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history
- •No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
排除标准
- •Subjects will be entered into the study only if they meet none of the following criteria.
- •Prior receipt of any COVID-19 vaccine in less than 6 months of duration
- •Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements
- •Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment
- •Pregnancy or breast-feeding
- •Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history
- •History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day
- •Chronic immune disease or systemic collagenosis in medical history
- •Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study
- •Splenectomy in the past medical history
- •Subjects with oncological disease within 5 years prior to inclusion into the study
- •Neutropenia (absolute number of neutrophils less than <1000/mm2), agranulocytosis, severe anemia (hemoglobin < 8 g/l)
- •Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment
- •Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
- •Acute Kidney injury or dialysis
- •Anorexia or Malnutrition
- •Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration
- •Alcohol or Drug addiction in medical history
- •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
To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of:
时间窗: Day 28 from baseline
• Proportion of subjects achieving ≥2-fold increase in neutralizing antibodies at Day 28 from baseline
时间窗: Day 28 from baseline
次要结局
- To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of:(• GMT and GMFR for SARS-CoV-2 glycoprotein specific antibody on days 28, 90 and 180)
- • Proportion of subjects achieving ≥2-fold increase in SARS-CoV-2 glycoprotein specific antibodies at Day 28 from baseline(• CD4/CD8 lymphoproliferation after RBD stimulation on day 28)