Not recruiting

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

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

4 criteria

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 trial?

7 criteria

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.

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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.

What is already known about the treatment

COVID-19 Vaccine – This medication is administered as an injection, typically into the muscle of the upper arm. It is currently widely used and studied in medical literature as a key tool in combating the COVID-19 pandemic. The main purpose of the vaccine is to prevent COVID-19 infection by stimulating the body's immune system to recognize and fight the virus. At the molecular level, the vaccine introduces a harmless component of the virus, such as a protein, which triggers an immune response without causing the disease. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

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.