Study on Immune Responses to COVID-19 Vaccines: Raxtozinameran, Bretovameran, and Drug Combination for COVID-19 Patients

3 1 1 1

What is this study about?

This clinical trial focuses on studying the immune responses after receiving different formulations of the COVID-19 vaccine. The study involves several vaccines, including Comirnaty Omicron XBB.1.5, Comirnaty JN.1, COVID-19 Vaccine AstraZeneca, Spikevax bivalent Original/Omicron BA.1, Comirnaty Original/Omicron BA.4-5, Comirnaty, Nuvaxovid, and Spikevax. These vaccines are designed to help the body develop immunity against the virus that causes COVID-19.

The purpose of the study is to evaluate how well the immune system responds to these vaccines. Participants will receive different vaccine products, and their immune responses will be monitored over time. The study will look at the levels of antibodies, which are proteins made by the immune system to fight infections, and other immune responses in people who have received the vaccines. This includes those who have had different numbers of doses, those who received the vaccine at different intervals, and those who belong to various age groups or have different health conditions.

The study will take place over several years, with the aim of understanding how well these vaccines work against different variants of the virus. By the end of the study, researchers hope to gather valuable information on the effectiveness of these vaccines in providing protection against COVID-19.

1 joining the study

Upon joining the study, ensure that all necessary consent forms are signed. This confirms understanding of the study and agreement to participate.

Receive detailed information about the study’s purpose, procedures, and any potential risks or benefits.

2 initial vaccination

Receive the first dose of the COVID-19 vaccine as per the study protocol. The vaccine is administered as an intramuscular injection.

The specific vaccine product and dosage will be determined based on the study group assignment.

3 follow-up visits

Attend scheduled follow-up visits to monitor health and immune response. These visits may include blood tests to measure antibody levels.

Report any side effects or health changes experienced after vaccination.

4 second vaccination

Receive the second dose of the COVID-19 vaccine as per the study schedule. The timing of this dose may vary (e.g., 3 weeks, 8 weeks, or 12 weeks after the first dose).

The second dose is also administered as an intramuscular injection.

5 ongoing monitoring

Continue attending follow-up visits for ongoing monitoring of immune response and overall health.

Additional blood tests may be conducted to assess antibody levels and immune responses over time.

6 final assessment

Participate in a final assessment to evaluate the long-term immune response to the vaccine.

This assessment may include a comprehensive review of health status and any changes observed during the study period.

Who Can Join the Study?

Must be at least 18 years old.
Has received or is planning to receive at least one dose of a COVID-19 vaccine as per the national vaccination program.
Is able to understand the given written and spoken information about the study.
Has given written informed consent, which means you agree to participate after being informed about the study details.

Who Cannot Join the Study?

Having a current or recent COVID-19 infection.
Being outside the age range of 18 to 65 years old.
Being pregnant or breastfeeding.
Having a weakened immune system, which means your body has a harder time fighting infections.
Having a history of severe allergic reactions to vaccines.
Participating in another clinical trial at the same time.
Having any other medical condition that the study doctors think might make it unsafe for you to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Finnish Institute For Health And Welfare	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	15.10.2021

Trial locations

Investigated drugs:

COVID-19 Vaccine is a type of medicine designed to help your body fight off the virus that causes COVID-19. It works by teaching your immune system to recognize and attack the virus if you are exposed to it in the future. This helps to prevent you from getting sick with COVID-19 or reduces the severity of the illness if you do get infected. The vaccine is given as an injection, usually in the arm, and may require more than one dose to be fully effective.

Investigated diseases:

COVID-19

COVID-19 infection – COVID-19 infection is caused by the SARS-CoV-2 virus, which primarily affects the respiratory system. The disease begins with the virus entering the body, often through the nose or mouth, and attaching to cells in the respiratory tract. Initial symptoms can include fever, cough, and fatigue, which may progress to more severe respiratory issues such as difficulty breathing. In some cases, the infection can lead to pneumonia, acute respiratory distress syndrome, and other complications. The virus can also affect other organs, leading to symptoms like loss of taste or smell, gastrointestinal issues, and neurological effects. The progression and severity of the disease can vary widely among individuals, influenced by factors such as age, underlying health conditions, and immune response.

Trial ID:

2024-517357-27-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Immune Responses to COVID-19 Vaccines: Raxtozinameran, Bretovameran, and Drug Combination for COVID-19 Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?