A Clinical Study to Test the Side Effects and Antibody Levels after Hetero-COVID Vaccine in Healthy Adults

Phase 3

Completed

• Registration Number: CTRI/2021/05/033665
• Lead Sponsor: Hetero Biopharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-09-02
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 227

Inclusion Criteria

1. Adult male or female volunteers aged 18-65 years (inclusive of both) who are not vaccinated for COVID-19/Influenza and willing to give written, signed and dated informed consent to participate in the study

2. Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result

3. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit

4. No acute infections and/or respiratory diseases within 14 days before enrollment

5. Negative human immunodeficiency virus (HIV 1 & 2), Syphilis, Hepatitis B and C test results

Exclusion Criteria

1. Any vaccination/immunization within 30 days before the enrollment

2. Usage of Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment

3. Immunosuppressive therapy within 3 months before the enrollment

4. Donated blood or plasma within 3 months before enrollment

5. Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past 6 months before enrollment

6. Participation in any other interventional clinical trial within 3 months

7. Volunteer is pregnant or breast-feeding

8. History or evidence of Tuberculosis or chronic systemic infections

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titre (GMT) Ratio of SARS-CoV-2 glycoprotein-specific antibodiesTimepoint: Day 28 and Day 42

Secondary Outcome Measures

Name	Time	Method
GMT ratio of SARS-CoV-2 glycoprotein-specific antibodiesTimepoint: Day 21;Incidence of AEs and SAEs following vaccination during the studyTimepoint: All Visits;Incidence of cases of Covid-19Timepoint: Day 21 and Day 42;Number of proliferating CD4 and CD8 cells in response to mitogen stimulation and their ratios in cell mediated immunogenicity (T-cell mediated immunity)Timepoint: Day 21, Day 28 and Day 42