CTRI/2020/09/027674已完成1 期
An Adaptive, Seamless Phase 1, Followed by a Phase 2, Randomized, Multicenter Studyto Evaluate the Safety, Reactogenicity, and Immunogenicity of the Whole Virion Inactivated SARS-CoV-2 Virus Vaccine, BBV152D Administered Intradermally in Healthy Volunteers. - COVID ID STUDY
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 145
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.
- •2. Participants of either gender age between >=18 to <=55 years. (Phase 1)
- •3. Participants of either gender age between >=12 to <=65 years. (Phase2)
- •4. Good general health as determined by the discretion of investigator (vital signs
- •(Pulse 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).
- •5. Expressed interest and availability to fulfil the study requirements.
- •6. 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 4 weeks after the last vaccination and agrees not
- •to participate in another clinical trial at any time during the study period.
- •7. Sexually active men who are considered sexually fertile must agree to use a
- •barrier method of contraception and agree to continue the use for at least 3
- •months following the last vaccination, or have a partner who is permanently
- •sterile or is medically unable to become pregnant.
- •8. Male subjects agree to refrain from sperm donation from the time of first
- •vaccination until 3 months after last vaccination.
- •9. Participants must refrain from blood or plasma donation from the time of first
- •vaccination until 3 months after last vaccination.
- •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
排除标准
- •1. History of any other COVID-19 investigational vaccination.
- •2. Unacceptable laboratory abnormality from screening (before first vaccination)
- •or safety testing as listed below.
- •ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen
- •(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will
- •be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and
- •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 ELISA.
- •4. Pregnancy, lactation or willingness/intention to become pregnant during the
- •5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness
- •such as an upper respiratory infection or gastroenteritis within 3 days before
- •each dose of vaccine.
- •6. Medical, problems as a result of alcohol or illicit drug use during the past 12
- •7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days
- •before enrolment or expects to receive an experimental agent during the study
- •8. Known sensitivity to any ingredient of the study vaccines, or a more severe
- •allergic reaction and history of allergies or anaphylaxis concerning vaccination
- •in the past.
- •9. Receipt of immunoglobulin or other blood products or blood transfusions
- •within the 3 months before vaccination in this study.
- •10. Either Immunosuppressant or Immunocompromised status, 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
- •11. 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 6 months (nasal and topical steroids are
- •12. Any history of hereditary angioedema or idiopathic angioedema.
- •13. History of any cancer.
- •14. History of serious psychiatric conditions likely to affect participation in the
- •15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder),
- •or prior history of significant bleeding following venipuncture.
- •16. Any other serious chronic illness requiring hospital specialist supervision.
- •17. Chronic respiratory diseases (SARS), including mild asthma
- •18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal
- •disease, an endocrine disorder, and neurological illness
- •19. Morbidly Obese (BMI>=35 kg/m2) or underweight (BMI <=18 kg/m2).
- •20. Living in the same household of any COVID-19 positive.
- •21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since
- •May 2020. Should a reliable test become available, these exclusion criteria will
- •be replaced with seropositivity for COVID-19 before enrolment.
- •22. 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 th
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