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CTRI Number  CTRI/2021/08/035655 [Registered on: 13/08/2021] Trial Registered Prospectively
Last Modified On: 12/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective study 
Study Design  Other 
Public Title of Study   Effectiveness of Covid-19 vaccination and incidence of SARS-COV-2 reinfection in healthcare and frontline workers working in a tertiary cancer centre of India. 
Scientific Title of Study   A retrospective study to assess the effectiveness of Covid-19 vaccination and incidence of SARS-COV-2 reinfection in healthcare and frontline workers working in a tertiary cancer centre of India. 
Trial Acronym  NO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudeep Gupta 
Designation  Professor Department of Medical Oncology , Director ACTREC 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Homi Bhabha Block Room no 1109, 11th floor Dr. Ernest Borges Marg. Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  912224177201  
Fax  912224177201  
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudeep Gupta 
Designation  Professor Department of Medical Oncology , Director ACTREC 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Homi Bhabha Block Room no 1109, 11th floor Dr. Ernest Borges Marg. Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  912224177201  
Fax  912224177201  
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudeep Gupta 
Designation  Professor Department of Medical Oncology , Director ACTREC 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Homi Bhabha Block Room no 1109, 11th floor Dr. Ernest Borges Marg. Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  912224177201  
Fax  912224177201  
Email  sudeepgupta04@yahoo.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr. Ernest Borges Marg Parel Mumbai Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre  
Address  Tata Memorial Hospital Dr. Ernest Borges Marg Parel Mumbai 400012 Maharashtra 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  Not applicable  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudeep Gupta  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  Vaccination Centre, 2nd floor, archival block building Sector 22 Kharghar, Navi Mumbai - 410210. Maharashtra, India.
Mumbai (Suburban)
MAHARASHTRA 
02268735075
02227405080
sudeeepgupta04@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COVID-19 Vaccination in Healthcare and Frontline Workers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Healthcare and frontline workers from a single tertiary cancer centre
2.HCW and FLW between the age of 18-80 years and willing for the vaccination
 
 
ExclusionCriteria 
Details  1.Non-healthcare care and non- frontline workers
2.Healthcare and frontline workers from other hospitals
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome
1. To assess the efficacy of vaccination for the prevention of SARS-COV-2 in healthcare and frontline workers.

 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 

1.To assess the incidence of reinfection following natural infection.
2.To assess the number of HCW & FLW who are not vaccinated and the reasons for not taking the vaccine.
 
6 months 
 
Target Sample Size   Total Sample Size="1760"
Sample Size from India="1760" 
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)   23/08/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

         Protocol summary 

This is a retrospective study done to find out the efficacy of the vaccine in healthcare and frontline workers. The healthcare and frontline workers are more prone toSARSCOV-2 infection due to close contact with the patients and also working daily in the hospital where chances of contracting the SARS-COV-2 is very high. There is scarcity of the data regarding the efficacy of the vaccine after 1st and 2nd dose in healthcare and frontline beneficiaries working in oncology centres. We are analyzing a database maintained at our tertiary cancer centre from 25 January to 18 June 2021 of HCW and FLW who were vaccinated in between the stipulated period. The analysis includes the positivity rate after 1st, 2nd dose and without any vaccination. Also, the median number of days of hospitalization required after 1st, 2nd dose and without any vaccination. The data of HCW and FLW who developed reinfection following their recovery and incidence of recurrence will also be analysed. 

        Aim & Objectives 

Primary objective   

To assess the efficacy of vaccines in the prevention of SARS-COV-2 in healthcare and frontline workers. Factors tested were age, gender, type of vaccine taken, number of doses taken, hospitalization required or not & percentage of HCW and FLW positive with vaccination and without vaccination. 

Secondary objective 

To assess the incidence of SARS-COV-2 reinfection following natural infection. 

Study Population

Inclusion criteria 

1. Healthcare and frontline workers from a single tertiary cancer centre 

2.  HCW and FLW between the age of 18-80 years and willing for the vaccination 

Exclusion criteria 

  1.Non-healthcare care and non- frontline workers 

                 2.Healthcare and frontline workers from other hospitals 

         Trial design :Retrospective analysis 

          Study setting :This study would be a retrospective review of healthcare and frontline workers who were vaccinated for the prevention of SARS-COV-2 infection and also who got reinfected after natural infection in a single tertiary Cancer Centre from India.  



Methodology :This is a retrospective study. The vaccination program at our Centre was started from 25th January 2021 and is ongoing. We maintained an excel sheet of the healthcare and frontline workers who were vaccinated at our Centre on a day to day basis. The excel Sheet contains the ID number, name, age, gender, type of the vaccine given, date of the first vaccine taken, date of the second vaccine given, date of positivity after 1st dose of vaccine, date of positivity after 2nd dose of the vaccine, positivity in non-vaccinated people after the start of vaccination program, overall SARS-COV-2 infection, SARS-COV-2 reinfection following natural infection.The analysis is done to find out the SARS- COV-2 positivity rate, SARS- COV-2 reinfection and number of days of hospitalization after the 1st dose, 2nd dose and without vaccination. 

        Sample size estimationIt’s a retrospective analysis hence no formal sample size calculation is done.  

      Infection after vaccination against SARS-COV-2  

 One-dose vaccine analysis 

The probability of infection with SARS-COV-2 will be computed in individuals who have received one dose of vaccine against SARS-COV-2 starting with the first known healthcare worker recipient of vaccine in ACTREC up to the last person vaccinated prior to the data cutoff date of 18th June, 2021. The denominator for one-dose analysis will be all individuals who have received at least one dose of the vaccine prior to data cutoff date. The probability of infection after one-dose will be computed using time-to event Kaplan Meier analysis with period of risk (time point zero on ‘x’ axis) beginning with the date of 1st vaccine dose for each individual. Infection will be defined as RTPCR positivity for SARS-COV-2 at any point of time after receiving one of the vaccines and prior to receiving the 2nd dose of the vaccine, and will constitute an ‘event’ for the purpose of this analysis. For the one-dose analysis, individuals who have not experienced SARS-COV-2 infection by the date of second dose, will be censored on the date of receiving 2nd dose of the vaccine, or on the data cut-off date of June 2021 if they have not received the 2nd dose of the vaccine. The median follow-up for one-dose analysis will be the median of the time intervals from the date of 1st vaccine dose to the date of 2nd vaccine dose or the data cut-off date (in those who have not received two doses) among individuals who have not experienced an ‘event’. The readout of this analysis will be the probability of SARS-COV-2 infection-free survival after one dose of the vaccine. 

 Two-dose vaccine analysis 

The probability of infection with SARS-COV-2 will be computed in individuals who have received two doses of the vaccine, starting with the first known healthcare worker recipient of vaccine in ACTREC up to the last person vaccinated with the second dose, prior to the data cut-off date of 18th June, 2021. The denominator for the two-dose analysis will be all individuals who have received two doses of the vaccine, prior to data cut-off date. The probability of infection after two-doses will be computed using time-to-event Kaplan Meier analysis with period of risk (time point zero on ‘x’ axis) beginning with the date of second vaccine dose, for each individual. Infection will be defined as RT-PCR positivity for SARS-COV-2 at any point of time after receiving the second dose of the vaccine and will constitute an ‘event’ for the purpose of this analysis. Individuals who are not known to have experienced documented SARSCOV-2 infection after receiving two doses of the vaccine will be censored on the date of last follow-up or the data cutoff date of 18th June 2021, whichever is earlier. The median follow-up for two-dose analysis will be the median of the time intervals from the date of 2nd vaccine dose to the date of last follow-up or the data cutoff date, whichever is earlier, among individuals who have not experienced an ‘event’. The readout of this analysis will be the probability of SARS-COV-2 infection-free survival after two doses of the vaccine. 

Reinfection after prior infection with SARS-CoV-2 

The probability of reinfection with SARS-COV-2 will be computed in individuals who have been known to be infected (RT-PCR for SARS-COV-2 positive) with this virus on one occasion, starting with the first known infection among ACTREC healthcare workers up to the last person infected prior to the data cut off date of 18th June, 2021. This number will constitute the denominator for this analysis. The probability of reinfection will be computed using time-to-event Kaplan Meier analysis with period of risk (time point zero on ‘x’ axis) beginning with the date of 1stinfection for each individual. Reinfection will be defined as RT-PCR positivity for SARS-COV-2 at least 8 weeks from the date of known RT-PCR negativity after 1stinfection or, if RT-PCR negativity after prior infection is not documented, at least 8 weeks from the date of rejoining work. Individuals who experience re-infection with SARS-COV-2 up to the data cutoff date will be considered to have experienced an ‘event’ for the purpose of this analysis while individuals who are not known to have experienced documented SARS-COV-2 reinfection will be censored on the data cutoff date. Individuals who experience death after 1stinfection of SARS-COV-2 will be censored on the date of death. The median follow-up for this analysis will be the median of time intervals from the date of 1stinfection to the date of last follow-up of each individual, or data cutoff date, whichever is earlier, in individuals who have not experienced an ‘event’. The readout of this analysis will be the probability of SARS-COV-2 reinfection-free survival. We acknowledge that receipt of vaccine will add another dimensions to the analysis of reinfection after prior infection. However cases of reinfection who have also received vaccine to prior the reinfection will not be excluded from the reinfection analysis, and such cases will be descriptively reported as a subset of reinfection cases.


 
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