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Submitted URL: http://sisonkestudy.samrc.ac.za/
Effective URL: https://sisonkestudy.samrc.ac.za/
Submission: On November 14 via api from US — Scanned from US

Form analysis 1 forms found in the DOM

POST

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      <h2 style="color:white;">Contact us </h2>
      <p>&nbsp;</p>
      <h3 style="color:white;">Sisonke desk: 0800 014 956</h3>
      <p>&nbsp;</p>
      <p style="color:white;">
        <font size="-1"><strong>Oversight ethics committee:</strong><br> South African Medical Research Council, Human Research Ethics Committee<br>
        </font>
      </p>
      <p>&nbsp;</p>
      <p style="color:white;">
        <font size="-1"><strong>REGULATORY APPROVAL</strong><br> If you have questions about this study you should first discuss them with the Clinical Research Site team, or the Sisonke Safety Desk, or the related Ethics Committee. If you have not
          been provided with answers to your satisfaction, you should write to the South African Health Products Regulatory Authority (SAHPRA) who provides regulatory approval for the study at: South African Health Products Regulatory Authority,
          Department of Health, Private Bag X828; PRETORIA; 0001 </font>
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Text Content

 * Home
 * About
 * Eligibility
 * SHERPA Resources
 * Sisonke Study 1
 * Sisonke Study 2
 * Contact Us

Menu


SISONKE STUDY

Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S

Find Out More





ABOUT SHERPA

Short for Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.S, the
SHERPA Study’s primary objective is to evaluate the effectiveness of the
heterologous mRNA-1273 (Moderna) boost against COVID-19 infections and severe
COVID-19 disease among health care workers.

The study aims to enroll up to 15 000 Sisonke participants who have received
either a single or two doses of Ad26.COV2.S. This will allow the study team to
investigate the effectiveness of the Moderna COVID-19 vaccine booster against
the new variants in South Africa, as well as provide the South African Health
Products Regulatory Authority (SAHPRA) with additional data on this vaccine for
potential licensing.



ELIGIBILITY

Who can enroll?

 * •  Anyone who has received either a single or two doses of Ad26.COV2.S
   through the Sisonke study and you are 18 years or older
 * •  If you are pregnant or breastfeeding at the time of enrolment you can join
   the study.
 * •  You must be willing and able to comply with the vaccination plan and other
   study procedures.
 * •  You must be capable and willing to provide informed consent


You may NOT enrol

 * •  If you have received any COVID-19 vaccines other than one or two doses of
   Ad26.CoV2.S through other means (for example, another mRNA booster dose).
 * •  If you are currently participating in any other research studies (other
   than Sisonke) that would interfere with the objectives of this study.
 * •  If you have had COVID-19 or a COVID-19 illness within 14 days of enrolment
 * •  If you have a history of heparin-induced thrombocytopenia, or thrombosis
   and thrombocytopenia syndrome.
 * •  If you have a history of severe adverse reaction associated with a vaccine
   and/or severe allergic reaction (e.g., anaphylaxis) to any component of
   mRNA-1273.


How to enroll?
Contact your nearest SHERPA site if you receive the SMS about the SHERPA study
or click on the link https://redcap.link/sherpa

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL

Building a healthy nation through research, innovation and transformation

Read more

 

CENTRE FOR THE AIDS PROGRAMME OF RESEARCH IN SOUTH AFRICA

Generating Knowledge - Impacting Health

Read More

 

DESMOND TUTU HEALTH FOUNDATION

Lessen the impact of the HIV epidemic on individuals, families and communities

Read More

MODERNA

Pioneering mRNA technology

 

Read More

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL

Building a healthy nation through research, innovation and transformation

Read more

 

CENTRE FOR THE AIDS PROGRAMME OF RESEARCH IN SOUTH AFRICA

Generating Knowledge - Impacting Health

Read More

 

DESMOND TUTU HEALTH FOUNDATION

Lessen the impact of the HIV epidemic on individuals, families and communities

Read More

MODERNA

Pioneering mRNA technology

 

Read More

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL

Building a healthy nation through research, innovation and transformation

Read more

 

CENTRE FOR THE AIDS PROGRAMME OF RESEARCH IN SOUTH AFRICA

Generating Knowledge - Impacting Health

Read More
‹›



SHERPA RESOURCES




PRESS RELEASES

SAMRC launches a study to evaluate the effectiveness of the Moderna booster, 1
June 2022

INFORMATION

 

•  Participants Information and Consent Form - An example of an information
   sheet and consent form. (Please note that the information and consent process
will    occur at each clinical research site)

•  SHERPA study Frequently Asked Questions

•  Participant letter -  7 Oct 2022 


CONTACT US

 


SISONKE DESK: 0800 014 956

 

Oversight ethics committee:
South African Medical Research Council, Human Research Ethics Committee


 

REGULATORY APPROVAL
If you have questions about this study you should first discuss them with the
Clinical Research Site team, or the Sisonke Safety Desk, or the related Ethics
Committee. If you have not been provided with answers to your satisfaction, you
should write to the South African Health Products Regulatory Authority (SAHPRA)
who provides regulatory approval for the study at: South African Health Products
Regulatory Authority, Department of Health, Private Bag X828; PRETORIA; 0001

Copyright © 2022 Sisonke. Hosted by the: South African Medical Research Council

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