CTRI/2021/07/034625
Completed
未知
A Randomized, Double-blind, Placebo Controlled, Parallel-Group, Proof of Concept study to Assess the Safety and Immunogenicity of AYURVEDIC Capsules in Indian Healthy Subjects who have completed the vaccination (COVAXIN) for COVID-19. - A Randomized, Double-blind, Placebo Controlled, Parallel-Group, Proof of Concept study to Assess the Safety and Immunogenicity of AYURVEDIC Capsules in Indian Healthy Subjects who have completed the v
ACE Hospital and shripad medisearch Pvt Ltd Pune0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ACE Hospital and shripad medisearch Pvt Ltd Pune
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Written informed consent of a subject to participate in the trial
- •b) Males and females aged 18\+ years and 70 years
- •c) Negative human immunodeficiency virus (HIV 1 \& 2\) and hepatitis B and C test results
- •d) Patients who has received COVAXININ 2nd dose in a last 30 to 45 days of time to be enrolled in the study.
- •e) Negative COVID\-2019 Reverse Transcriptase\-Polymerase Chain Reaction (RT\-PCR) test result at the screening visit (72 hours prior to Visit 1 \[Day 1]
- •f) No COVID\-2019 in the medical history at least 3 months prior to study participation
- •g) History of no contact withCOVID\-2019 persons within at least 14 days before the enrolment (according to subjects)
- •h) Consent for using effective methods of contraception during the entire trial
- •i) Negative urine pregnancy test at the screening visit (for child\-bearing age women)
- •j) No evident vaccine\-induced reactions or complications after receiving immunobiological products in the medical history
Exclusion Criteria
- •a) Any vaccination/immunization within 30 days before the enrolment
- •b) Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment
- •c) Immunosuppressors therapy finished within 3 months before the enrolment
- •d) Pregnancy or breast\-feeding
- •e) Acute coronary syndrome or stroke suffered less than one year before the enrolment
- •f) Tuberculosis, chronic systemic infections
- •g) Drug allergy (anaphylactic shock, Quincke edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
- •h) Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine
- •i) Medical history of malignancy
- •j) Donated blood or plasma (450\+ mL) within 2 months before the enrolment
Outcomes
Primary Outcomes
Not specified
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