Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated with EUA Vaccines.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 875
- 试验地点
- 9
- 主要终点
- 1. Geometric mean titres (GMTs) of serum neutralising antibody titer (NAb’s) by Neutralising Antibody
研究概览
简要总结
Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated with EUA Vaccines.
STUDY DESIGN:
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
Group 1 (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
Group 2 (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3 (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.
Group 4 (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.
Group 5 (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of COVISHIELD vaccine, in individuals previously vaccinated with COVISHIELD.
In addition to administering the vaccine, a series of blood samples (Immunogenicity Subset) will be collected for analyzing serum for immunological assessments. A subset of 150 participants each in Groups 1 &3 and 75 participants each in Groups 2, 4, and 5 will be assessed for immunogenicity. Among this subset an additional 10 mL blood and 5 mL of saliva will be collected from 40 participants each in Groups 1 &3 and 20 participants each in Groups 2, 4, and 5 to assess the cell-mediated immune response and mucosal immunity, respectively
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to provide written informed consent.
- •Participants of either gender of age ≥18 years.
- •Received and completed Coronavirus Disease 2019 vaccine under Emergency Use Authorization (EUA) dosing guidelines at least 6 ± 1month (after receipt of second dose of EUA vaccine) prior to enrollment, confirmed by the electronic Covid-19 Certificate (CoWIN).
- •Expressed interest and availability to fulfill the study requirements.
- •For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after vaccination
- •Agrees not to participate in another clinical trial at any time during the study period.
- •Agrees to remain in the study area for the entire duration of the study.
- •Willing to allow storage and future use of biological samples for future research.
排除标准
- •Known history of COVID-19 infection.
- •For women of child bearing potential, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering vaccine).
- •Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness such as an upper respiratory infection or gastroenteritis within three days prior to vaccination.
- •Medical problems because of alcohol or illicit drug use during the past 12 months.
- •Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period.
- •Receipt of any licensed vaccine within four weeks before enrolment in this study.
- •Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
- •Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
- •Immunosuppression because of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- •Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
- •Any history of anaphylaxis in relation to vaccination.
- •History of any cancer.
- •History of severe psychiatric conditions likely to affect participation in the study.
- •Any other serious chronic illness requiring immediate hospital specialist supervision.
- •Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
结局指标
主要结局
1. Geometric mean titres (GMTs) of serum neutralising antibody titer (NAb’s) by Neutralising Antibody
时间窗: 1. Day 0 , 28 and 56
Assays
时间窗: 1. Day 0 , 28 and 56
次要结局
- 1. GMTs of serum IgG, IgA Abs by ELISA.(2. Vaccine induced T and B cell responses.)