Immunogenicity Assessment Extension Study of nCoV-2019novel coronavirus vaccine developed by Cadila Healthcare Ltd inPhase I part of Protocol NCOV 1002.

Phase 1

Completed

• Registration Number: CTRI/2021/02/031451
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-04
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1.Subjects has completed the Phase 1 study (NCOV 1002) in treatment arms 3 & 4 (i.e. 2

mg vaccine)

2. Willing to participate and provide informed consent for the study

Exclusion Criteria

1. Subjects who received another COVID vaccine after administration of last dose of

vaccine in NCOV 1002.

2. Subjects having history of positive documented COVID-19 infection after completion

of study in Phase I part of NCOV 1002

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Persistence of IgG antibodies titer in subjects after three months in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet) respectively and their comparison with the baseline within arms as well as between arms. <br/ ><br> <br/ ><br>2)The proportion of subjects with detectable IgG antibodies titers persisted after three months in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet) respectively and their comparison with the baseline IgG antibodies titers.Timepoint: Week 22

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects whoseâ?¥ four-fold IgG antibodies titers persisted after three months in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet) respectively and their comparison with the baseline IgG antibodies titers.Timepoint: Week 22;The proportion of subjects whoseâ?¥ three-fold IgG antibodies titers persisted after threemonths in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet)respectively and their comparison with the baseline IgG antibodies titersTimepoint: Week 22;The proportion of subjects whoseâ?¥ two-fold IgG antibodies titers persisted after threemonths in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet)respectively and their comparison with the baseline IgG antibodies titers.Timepoint: Week 22