COVID-19 Vaccine effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals

CTRI Number

CTRI/2021/01/030782 [Registered on: 27/01/2021] Trial Registered Prospectively

Last Modified On:

27/01/2021

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

COVID-19 Vaccine effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals

Scientific Title of Study

“A prospective, longitudinal, observational, postlicensure vaccine evaluation study to assess the effectiveness of COVID-19 vaccine among the Healthcare workers of Max group of hospitals”

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sujeet Jha
Designation	Principal Director
Affiliation	Max Healthcare
Address	Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket South DELHI 110017 India
Phone	9910609000
Fax
Email	sujeet.jha@maxhealthcare.com

Details of Contact Person
Scientific Query

Name	Sujeet Jha
Designation	Principal Director
Affiliation	Max Healthcare
Address	Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket DELHI 110017 India
Phone	9910609000
Fax
Email	sujeet.jha@maxhealthcare.com

Details of Contact Person
Public Query

Name	Sujeet Jha
Designation	Principal Director
Affiliation	Max Healthcare
Address	Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket DELHI 110017 India
Phone	9910609000
Fax
Email	sujeet.jha@maxhealthcare.com

Source of Monetary or Material Support

Max Healthcare and CSIR-IGIB

Primary Sponsor

Name	CSIRInstitute of Genomics and Integrative Biology
Address	DTC Bus Depot, South Campus, Mathura Road, near to Sukhdev Vihar, New Delhi, Delhi 110025
Type of Sponsor	Other [Council of Scientific and Industrial Research (CSIR)]

Details of Secondary Sponsor

Name	Address
Max Healthcare A Unit of Devki Devi Foundation	2, Press Enclave Road, Saket, New Delhi-110017

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Sujeet Jha	Max Super Speciality Hospitals	Saket, Vaishali, Patparganj, Gurgaon, Shalimar Bagh, Lajpat Nagar New Delhi DELHI	9910609000 sujeet.jha@maxhealthcare.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Devki Devi Foundation	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Undergoing COVID-19 vaccination

Intervention / Comparator Agent

Type	Name	Details
Intervention	Not applicable	Not applicable

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	• HCWs of Max group of hospitals, irrespective of age and gender • HCWs who are being offered Govt. of India approved COVID-19 vaccines Covishield or COVAXIN

ExclusionCriteria

Details

Refusal to give informed consent, or contraindication to venipuncture.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Seropositivity in participants after vaccination	7, 14, 28, 45, 90 days after vaccination, may be extended further

Secondary Outcome

Outcome	TimePoints
Effectiveness of COVID-19 vaccines	30 days, 90 days, may be extended further

Target Sample Size

Total Sample Size=“1000”
Sample Size from India=“1000”
Final Enrollment numbers achieved (Total)= “Applicable only for Completed/Terminated trials”
Final Enrollment numbers achieved (India)=“Applicable only for Completed/Terminated trials”

Phase of Trial

N/A

Date of First Enrollment (India)

05/02/2021

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years=“0”
Months=“6”
Days=“0”

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Yes, we will publish the results

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response – NO

Brief Summary

We have designed this study to evaluate COVID-19 vaccine effectiveness by antibody testing and evaluate vaccine hesitancy rate, among the healthcare workers of Max Group of Hospitals.

We would do antibody testing at day 0 (vaccination day or pre-vaccination) followed by 7, 14, 28, 45, 90th day of vaccination. This study would involve a brief questionnaire asking about the health status of the participants related to COVID-19 and side-effects post-vaccination.

NOTE

What is the Clinical Trials Registry – India?

The Clinical Trials Registry – India (CTRI) launched on 20^th July 2007 is managed by the ICMR-National Institute of Medical Statistics, New Delhi, India. The CTRI ( www.ctri.nic.in) is an online, free and searchable system for the prospective registration of all clinical studies being conducted in India. In addition, the CTRI also registers clinical studies being conducted in countries which do not have a Primary Registry of their own.

Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.

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