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

Immunogenicity Assessment Extension Study OF Phase 1 Part Of Protocol NCOV 1002

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/02/031451

Enrollment

Registered

2021-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: NOT APPLICABLE: NOT APPLICABLE Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Limited

kevinkumarkansagra@zyduscadila.com02717665555

Outcome results