CTRI/2021/02/031295
Completed
Phase 1
A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. - BBIL/BBV154/2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Ltd
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Ability to provide written informed consent.
- •2\. Participants of either gender of age between \>\=18 to \<\=60 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 fulfil 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.
- •10\. Agrees to remain in the study area for the entire duration of the study.
Exclusion Criteria
- •1\.History of any other COVID\-19 investigational/or licensed vaccination.
- •2\.Unacceptable laboratory abnormality at screening (prior to first vaccination) or safety testing, as listed below
- •3\.\[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).
- •4\.Confirmed SARS\-CoV\-2 at the time of screening using RT\-PCR and ELISA or CLIA method.
- •5\.Any history of facial nerve paralysis
- •6\.History of cold, sneezing, nasal obstruction in the past 3 days.
- •7\.Prescribed usage of any nasal spray/or nasal drop medication.
- •8\.Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)
- •9\.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 each dose of vaccine).
- •10\.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.
Outcomes
Primary Outcomes
Not specified
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