WHAT IS THE PURPOSE OF THE SURVEILLANCE?
The purpose of this surveillance is to examine the response of your immune system and the occurrence of COVID-19 after you receive COVID-19 vaccination. This surveillance is necessary because different people have different degree of immune response towards vaccination. The duration of immune response following vaccination also differs from individual to individual. In addition, while most COVID-19 vaccines protect recipients from death and severe disease requiring hospitalization, mild disease can still occur occasionally. The occurrence of COVID-19 post-vaccination needs to be monitored and reported. Information collected through this surveillance will help the Ministry of Health Malaysia understand the proportion of vaccine recipients with immunity after vaccination, the duration this immunity lasts, and the level of protection it provides. It will help us decide if the residents in Malaysia need a booster dose in the time to come, and when it is needed.
Data Collection will be conducted from
July 2021 - Disember 2023
8 - 9
5 - 15
IMSURE Frequently asked questions (FAQs)
What kind of surveillance will I receive?
If you agree to participate in the surveillance, the surveillance investigator may need to screen you to determine if you are suitable for the surveillance. If you are deemed suitable, your blood samples will be tested in the Institute for Medical Research, Setia Alam, for your immune response (antibodies level) before you receive your first dose of vaccine, before you receive your second dose of vaccine (if any). Subsequently, you will also be followed-up after 14 days of last dose, every three months for the first after your first dose of vaccine (at month 3, 6, 9, and 12) and every six months for the second year (at month 18 and 24).
What will happen if I decide to take part?
- Interview : After you have signed your consent form, you will be interviewed by a surveillance investigator for some important basic personal information, COVID-19 related questions, and risk factors for COVID-19. Your height, weight, and abdominal circumference will also be measured.
- Blood sample collection : Subsequently, blood sample will be taken from you following aseptic principles to ensure cleanliness and prevent cross-infection. The blood sample will be drawn from a vein using a needle. Around 10 ml (2 teaspoons) of venous blood will be obtained from you for the purpose of this surveillance. (If you are also selected to test the activity of your immune cells and the antibodies in your saliva, an additional 20 ml (4 teaspoons) of venous blood and 5 ml of saliva will also be obtained from you.)
- Vaccination and observation : After that, you will proceed to receive your vaccine shot and then to the observation bay like other vaccine recipients.
- Answer additional questions at the observation bay : You will be given a list of questions to answer on your own.
- Follow-up appointment setting and token : Finally, you will be given your surveillance follow-up card with next appointment date and a token for your time and contribution.
What are the potential risks and side effects of being in this surveillance?
The only risk you are exposed to in this surveillance is the risks associated with blood-sampling, such as profuse bleeding and blood-borne infection.
What are the benefits of being in this surveillance?
Personally, participation in this surveillance provides you information regarding your body immune response following vaccination. Beyond that, your contribution to the society and its member is far greater. Information collected through this surveillance will help the Ministry of Health Malaysia understand the proportion of vaccine recipients with immunity after vaccination, the duration this immunity lasts, and the level of protection it provides
Can the surveillance or my participation be terminated early?
The surveillance investigators or the funder may, due to concerns for your safety, stop the surveillance or your participation at any time. If the surveillance is stopped early for any reason, you will be informed.
Will the information obtained be kept confidential?
All your information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. All information will be used for survey and research purposes only.
Institut Kesihatan Umum (IKU)
Kompleks Institut Kesihatan Negara (NIH)
No.1, Jalan Setia Murni U13/52
Seksyen U13, Setia Alam
40170 Shah Alam, Selangor
Phone : 03-3362 7800
Email : email@example.com