proof of Concept study to Assess the Safety and Immunogenicity of Abayakasthaa plus Capsules in Indian Healthy Subjects who have completed the vaccination (COVAXIN) for COVID-19

Not Applicable

Completed

• Registration Number: CTRI/2021/07/034625
• Lead Sponsor: ACE Hospital and shripad medisearch Pvt Ltd Pune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-09-15
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

k) No acute infectious and/or respiratory diseases within at least 14 days before the enrollment

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

k) Splenectomy in the medical history

l) Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in IgG, IgA and IgM antibody levels from baseline to end of the treatment(immunogenicity) <br/ ><br>2.Change in T cells & Natural Killer (NK) cells countTimepoint: 1. Time Frame: Day 0 to Day 28]. <br/ ><br>2. Time Frame: Day 0 to Day 28].

Secondary Outcome Measures

Name	Time	Method
1. Change in IgG antibody for RBD and Spike protein COVID-antibodies levels. <br/ ><br>2. Assessment of safety and tolerability (AEs/SAEs)Timepoint: 1. Time Frame: Day 0 to day 28 <br/ ><br>2. Time Frame: Day 0 to day 28