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
- Geometric mean titres 1
研究概览
简要总结
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.
详细描述
Sample Collection:
- Pregnancy test will be conducted by using rapid test kit throughout the study.
- Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28, 56 (Subset n=150 each in Groups 1 &3 and 75 each in Groups 2, 4, and 5). Sera will collect from the blood sample and stored as 3 aliquots at -20°C.
- An additional blood sample (10 mL) will be collected for assessment of cell mediated responses on days 0, 28, 56 (Subset n=40each in Groups 1 & 3 and 20 each in Groups 2, 4, and 5).
- A saliva sample (5 mL) will be collected on days 0, 28, 56 (Same subset as for assessment of cell mediated responses). Saliva will be collected by Passive drool method using Falcon tube.
Sample Size:
A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent.
- •Participants of either gender of age ≥18 years.
- •Received and completed COVID-19 vaccine under Emergency Use Authorization (EUA) dosing guidelines at least 6 ± 1 month (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 the 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 of 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.
- •A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture).
- •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.
研究组 & 干预措施
Group 1(BBV154 in COVAXIN recipients)
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.
干预措施: BBV154 Intranasal Vaccine (Biological)
Group 2 (COVAXIN in COVAXIN recipients)
125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
干预措施: Intramuscular vaccine COVAXIN (Biological)
Group 3 (BBV154 in COVISHIELD recipients)
250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.
干预措施: BBV154 Intranasal Vaccine (Biological)
Group 4(COVAXIN in COVISHIELD recipients)
125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.
干预措施: Intramuscular vaccine COVAXIN (Biological)
Group 5 (COVISHIELD in COVISHIELD recipients)
125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
干预措施: Covishield (Biological)
结局指标
主要结局
Geometric mean titres 1
时间窗: baseline
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 2
时间窗: Day 28+2
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Geometric mean titres 3
时间窗: Day 56 ± 7
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
次要结局
- Cell mediated immune response(Day 56 ± 7)
- Geometric mean titres 4(Day 28+2)
- Geometric mean titres 5(Day 56 ± 7)
- Geometric mean titres(Day 28+2)
- Geometric mean titres (GMTs)(Day 56 ± 7)
- adverse events reported(7 days after vaccination)
- adverse events of special interest reported(throughout the study duration 7 months)
- vaccine induced thrombosis and thrombocytopenia(throughout the study duration 7 months)
- Cell mediated immune response(Day 28+2)