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

Phase 3

Completed

• Conditions: COVID-VAC Combined Vector Vaccine for SARS CoV2 Infection Prophylaxis

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

Brief Summary

This study is a prospective, randomized, interventional, double blind, active controlled, parallel group bridging clinical study to evaluate the safety and immunogenicity of Hetero-COVID-Vac Combined Vector Vaccine compared to Gam-COVID-Vac (Sputnik V - Manufactured for RDIF, Russia) in healthy adult human subjects. All subjects will be administered 2 doses of Hetero-COVID-Vac Combined Vector Vaccine (Component I & Component II) or Gam-COVID-Vac (Sputnik V) (Component I & Component II) with 21 days gap followed by assessments on Day 28 and 42.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-02-09
• Study Start: 2021-05-24
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• 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

• 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.

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 antibodies	Day 28 and Day 42

Secondary Outcome Measures

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

Trial Locations

Locations (7)

AIG Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

KLES Dr Prabhakar Kore Hopsital & Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Nizam Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

Peerless Hospitex Hospital and Research Center Limited; 🇮🇳 Kolkata, WEST BENGAL, India

SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

St, Theresa’s Hospital; 🇮🇳 Hyderabad, TELANGANA, India

St. George Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

AIG Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr Naveen Chander Reddy

Principal investigator

9848045814

drnaveen.reddy@aighospitals.com