A guide to volunteering for the Covid-19 vaccine

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20,000 volunteers applied for the Covid-19 vaccine of Chinese origin, which started phase-3 studies in Turkey. What criteria should those who want to volunteer for the coronavirus vaccine have? Here are the frequently asked questions about the vaccine study…

It was reported that those between the ages of 18 and 59 who have not previously had Covid-19 can volunteer to be administered the Covid-19 vaccine from China on the basis of “https://covid19asi.calismasi.info” or by calling 0850 811 18 80.

Here are the criteria for volunteering for the Covid-19 vaccine originating from China, which has started phase-3 studies in Turkey:

Eligible Participants

  • 18-59 years old (including 18 and 59 years old)
  • To be able to understand the information and to sign it voluntarily

Inappropriate Participants

  • Previously diagnosed with PCR positive COVID-19
  • IgG or IgM positive
  • Known allergy to the study vaccine
  • Pregnant or breastfeeding for women
  • Participation in another clinical trial with a research product within six months of being included in the study

Inclusion Criteria for The Study:

  1. 18-59 years old (including 18 and 59 years old)
  2. For the K1 cohort only, those who work in any department of health care organizations such as medical doctors, nurses, caregivers, cleaners, technicians, administrative staff
  3. To be able to understand the information and to sign it voluntarily

Non-Work Criteria:

  1. Previously diagnosed with PCR positive COVID-19
  2. IgG or IgM positive
  3. For women: To have sexual intercourse for reproductive purposes within three months of vaccination, without using pregnancy (approved by beta-hCG test), breastfeeding or contraception methods
  4. Known allergy to study vaccine or placebo components
  5. Use of immunosuppressant treatment regimens within six months before being included in the study or planning to use them within two years of participation. Immunosuppressant treatment regimens include: Immunosuppressants, antineoplastic chemotherapy, radiation therapy to induce transplant tolerance, among others
  6. The use of corticosteroids in immunosuppressive doses within three months of being included in the study and the planned use of corticoids in immunosuppressive doses within three months of being included in the study. Corticosteroids in immuno-depressant doses will be considered the equivalent prednizon of 20 mg/day for adults more than a week. Continuous use of topical or nasal corticoids will not be considered immunosuppressants.
  7. Aspleni story
  8. History of clotting disorder (e.g. lack of factor, coagulation or platelet disorder) or significant history of bleeding or bruising after IM injections or blood intake
  9. Alcohol or drug addiction for 12 months or more before starting work, causing medical, professional or family problems indicated by the clinical history
  10. Application of immunoglobulins and/or blood products within three months prior to planned administration of the vaccine
  11. Participation in one research product and another clinical trial within six months of being included in the study, or planned participation in another clinical trial within two years of registration
  12. Getting a weakened virus vaccine 14 days before being included in the study
  13. Inactive vaccination or subunit vaccination 7 days before being included in the study
  14. In the last 24 hours, fever (oral temperature> 37.2 °C, axial temperature will not be accepted.)
  15. In the opinion of the responsible researcher or representative physician, all other circumstances that may put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
  16. Any known or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection

Possible Benefits:

Previous steps of the study in China found that the creation of immune cells in the blood against COVID-19 was 98%. Therefore, it is possible to become immune to the COVID-19 pandemic with the vaccine applied because you participated in the study. However, if you are in the placebo arm, you will not have any immune cells against COVID-19. Therefore, it is not guaranteed that you will benefit from the work in any way. However, if the clinical efficacy of the vaccine is shown by this study, volunteers in the placebo arm will be the first group to be vaccinated. The information obtained from this study may be useful to other people in the future.

Possible Risks and Harms:

All research includes a bit of risk, and these risks may include factors that will make you feel sick or uncomfortable, or that will harm you. According to the findings from the previous stages of the study, the vaccine to be administered to you within the scope of the study can cause fever and diarrhea, and rarely vomiting, eating disorders, nausea, muscle pain, headache, fatigue. In the area where the vaccine is applied, it can cause pain and rarely redness, swelling and itching. For all these possible risks, you will be asked to wait in the observation room for 30 minutes after the vaccine is administered so that you can be monitored by the work team. There is a risk of pain or bruising and infection in the area where blood is taken for laboratory tests. There is also a small risk of fainting, which can occur in response to blood draw. When participating in the study, you may also experience negative effects associated with the work product. All participants of the study will be carefully monitored for all adverse effects. The volunteers who will be included in the study will not be allowed to enter the COVID-19 clinics of the study centers, and separate departments will be created in these centers for the study volunteers. In this way, COVID-19 patients and participants of this study will not be in the same place in any way. The study team can give you medications to help reduce negative effects. These effects can be mild or serious. You will not be asked to cover the costs/costs of the negative effects that may occur due to your participation in this study. If you suffer any damage caused by the treatment of the study, you will receive appropriate care and assistance, which costs you nothing.

This study is insured with the Insurance Policy TRLSCA40598 of Chubb European Group SE, which is prescribed by the supporter and covers any possible damage to your health as a result of your participation in the study.

Titles in The Post

  • Frequently Asked Questions About Vaccine Study
  • Which institutions are carrying out the COVID-19 Vaccine Study with the approval of?
  • How do I find out if I’m eligible for the COVID-19 Vaccine Study?
  • Will I be paid to be a part of this clinical trial?
  • What is a placebo?
  • What happens if I am diagnosed with COVID-19 during this study?
  • Can I leave the work while the work is in progress?
  • Would I be a COVID-19 patient from the vaccine being investigated?
  • What personal information is collected about us for the study?
  • How is my personal information protected?
  • Who approved this study?
  • Who is the supporter of this study?
  • I want to volunteer for the study, but I don’t want to go to the hospital.
  • What are the possible side effects if vaccinated?
  • If I participate in the study, will I never have COVID-19 again?
  • Is this vaccine going to corrupt my genetic code(DNA)?
  • Who developed this vaccine?
Frequently Asked Questions About Vaccine Study
Which institutions are carrying out the COVID-19 Vaccine Study with the approval of?

The COVID-19 Vaccine Study was initiated with the approval of the Turkish Medicines and Medical Device Authority (TITCK) —- ——- date and —- no.

How do I find out if I’m eligible for the COVID-19 Vaccine Study?

You should review the information on the “Work Criteria” tab and if there are no obstacles, you can request to participate in the study by contacting the phone number in the “Contact” section or from the “Appointment Request” section. This information will be forwarded to the research center of your choice and you will be invited to work if it is appropriate for you to participate in the study.

Will I be paid to be a part of this clinical trial?

YOU WILL NOT BE PAID ANY FEES for participating in this study and WILL NOT BE CHARGED ANY FEES DURING the study or from the social security institution to which you are affiliated.

What is a placebo?

It is an injector whose appearance is the same as the real vaccine but does not contain inactive viruses that provide vaccination but other auxiliary substances.

What happens if I am diagnosed with COVID-19 during this study?

Every volunteer involved in this study will be closely monitored by the study team and the study doctor. During the study, if you suspect that you have COVID-19, you will be tested and examined. If it is later determined that you have COVID-19, you will be treated with the most up-to-date treatment protocols of the Ministry of Health.

Can I leave the work while the work is in progress?

Since you voluntarily participated in the research, you can leave the research at any time with or without justification.

Would I be a COVID-19 patient from the vaccine being investigated?

There is an inactive virus in the research product to be applied to you. Therefore, you will not have COVID-19 due to the research product.

What personal information is collected about us for the study?

The study doctor and other work personnel will collect your personal information. This may include:

Name and Surname

Age

and gender

Address

and Phone

Number Medical story Used drug information Product taken from blood and nose

How is my personal information protected?

Within the scope of the study, all your medical and identity information will be kept confidential, not made public and your credentials will not be provided even if the research is published. However, the officials who supervise the quality of the work can be examined if necessary by ethics committees or official authorities. Everyone involved in the study, including the work sponsor and work team, acknowledges the importance of protecting your privacy and health and their legal obligations to do so. Therefore, the work team will take the necessary steps to protect your privacy, specifying your ID with only one code in all documents related to the work. Only the work team will have access to the key to the code (this key allows the work team to identify individuals). The data and results in which your credentials are hidden will be archived by your colleague and supporter in accordance with the Turkish Personal Data Protection Law No. 6698.

The results of this research will be used for scientific purposes; medical data about you may be used for scientific purposes if necessary.

Who approved this study?

This study has obtained the necessary permissions in accordance with all legal regulations in Turkey. Hacettepe University Clinical Research Ethics Committee and Ministry of Health received the necessary approvals from the Turkish Medicines and Medical Device Authority.

At the same time, the study was registered on the clinicaltrials.gov site with the number NCT04582344.

Who is the supporter of this study?

This study is supported by the Turkish Institutes of Health (TÜSEB) affiliated to the Ministry of Health. TÜSEB Project code is 9026-ASI.

I want to volunteer for the study, but I don’t want to go to the hospital.

The locations within the hospital where the study was carried out were organized separately from the places where COVID-19 patients were. For this reason, covid-19 patients will not be present in the process of being included in the study or where you expect them during vaccination. Only healthy volunteers who participated in the study will be found.

What are the possible side effects if vaccinated?

There may be some pain, pain or burning sensation in your vaccinated arm due to the needle entering your skin. This will pass shortly.

Previous studies on this research product have shown mild side effects such as mild fever, muscle pain, headache, fatigue within a few days of vaccination.

If I participate in the study, will I never have COVID-19 again?

There are two groups in the study: real vaccine and placebo. If you are assigned to the actual vaccine groupby the system, there is a very high probability that immune cells will develop against COVID-19 in your blood, according to information from the earlier stages of the study. But if you are assigned to the placebo arm,the immune cell will not develop. With this study, it will be understood whether the immune cell created by the real vaccine really protects you against the COVID-19 virus. Therefore, we do not know with the current information whether your participation in the study protects you from COVID-19, but this study will answer this question.

Is this vaccine going to corrupt my genetic code(DNA)?

The vaccine to be administered for the study contains only the inactive COVID-19 virus. Inactive viruses do not affect your DNA, they only allow your immune system to create antibodies against this virus.

Who developed this vaccine?

The vaccine to be used during the research was developed by Sinovac, a private biotechnology company in the People’s Republic of China. In 2003, the same company developed a vaccine for SARS-CoV virus seen in the world. SARS-CoV virus is the previous type of SARS-Cov-2, or COVID-19 virus. Due to the fact that the two viruses are from the same family, the stages of vaccine development were realized quickly.