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

A Prospective, Randomized, Interventional, Parallel, Multi-Center, Comparative Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-Vac Combined Vector Vaccine (Manufactured by Hetero) in Healthy Adult Human Subjects.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033665

Enrollment

228

Registered

2021-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: COVID-Vac Combined Vector Vaccine (manufactured by Hetero) : Component I: Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Shubhadeep Sinha

Hetero Labs Limited

sreenivasa.chary@heterodrugs.com04023704923

Outcome results