CTRI/2020/07/026300已完成1 期
An Adaptive, Seamless Phase 1, Followed by Phase 2 Randomized, Double-blind, Multicenter Studyto Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-VirionInactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers - BBV152
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 755
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Ability to provide written informed consent (Audio video consent for vulnerable
- •2. Participants of either gender of age between >=18 to <=55 years.
- •3. Good general health as determined by the discretion of investigator (vital signs (heart rate >=60 to<=100 bpm; blood pressure systolic >=90 mm Hg and <140 mm
- •Hg; diastolic >= 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical
- •history, and physical examination).
- •4. Expressed interest and availability to fulfill the study requirements.
- •5. 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 last vaccination
- •6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
- •7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
- •8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
- •9. Agrees not to participate in another clinical trial at any time during the study period.
- •10. Agrees to remain in the study area for the entire duration of the study.
- •11. Willing to allow storage and future use of biological samples for future research.
- •1. Ability to provide written informed consent (Audio video consent for vulnerable subjects).
- •2. Participants of either gender of age between >=12 to <= 65 years.
- •3. Good general health as determined by the discretion of investigator (vital signs (heart rate >=60 to<=100 bpm; blood pressure systolic >=90 mm Hg and <140 mm
- •Hg; diastolic >= 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
- •4. Expressed interest and availability to fulfill the study requirements.
- •5. For a female participant of child-bearing potential, 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 last vaccination and agrees not to participate in another clinical trial at any time during the study period.
- •6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
- •7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
- •8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination.
- •9. Agrees to remain in the study area for the entire duration of the study.
- •10. Willing to allow storage and future use of biological samples for future research.
排除标准
- •1. History of any other COVID-19 investigational vaccination.
- •2. Unacceptable laboratory abnormality from screening (prior to first vaccination)
- •or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen].
- •(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary
- •care provider for follow up of these abnormal laboratory tests.)
- •3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method.
- •4. Health care workers.
- •5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
- •6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness
- •such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
- •7. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
- •8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period.
- •9. Receipt of any licensed vaccine within four weeks before enrolment in this study.
- •10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
- •11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
- •12. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- •13. 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).
- •14. Any history of hereditary angioedema or idiopathic angioedema.
- •15. Any history of anaphylaxis in relation to vaccination.
- •16. Any history of albumin-intolerance.
- •17. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
- •18. History of any cancer.
- •19. History of psychiatric severe conditions likely to affect participation in the study.
- •20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
- •21. Any other serious chronic illness requiring hospital specialist supervision.
- •22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
- •23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
- •24. Morbidly obese (BMI>=35 kg/m2) or underweight (BMI <=18 kg/m2).
- •25. Living in the same household of any COVID-19 positive person.
- •26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights
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