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Study on Pneumococcal Vaccine Response in Healthy Volunteers Using Pneumococcal Polysaccharide Conjugate Vaccine and Drug Combination

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What is this trial about?

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

This clinical trial is focused on studying the body's immune response to the pneumococcal vaccine. Pneumococcal disease is caused by bacteria that can lead to serious infections like pneumonia, meningitis, and bloodstream infections. The study involves two vaccines: Apexxnar, a 20-valent pneumococcal polysaccharide conjugate vaccine, and Prevenar 13, a 13-valent pneumococcal polysaccharide conjugate vaccine. Both vaccines are designed to protect against different strains of the bacteria that cause pneumococcal disease.

The purpose of the study is to understand how the immune system, particularly the lymph nodes, responds to these vaccines. Lymph nodes are small glands that play a crucial role in the body's defense against infections. The study will look at the timing of the peak response of certain immune cells, known as B cells, in the lymph nodes after vaccination. It will also examine other immune cells, such as T cells, and various markers that indicate how the immune system is reacting.

Participants in the study will receive one of the vaccines and will have samples taken from their lymph nodes and blood at different times. These samples will help researchers understand the changes in immune cells and the levels of cytokines, which are substances that help regulate the immune response. The study aims to provide insights into how well the vaccines work in stimulating the immune system to protect against pneumococcal disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, participants will attend an initial visit. During this visit, eligibility will be confirmed based on age and health criteria. Participants should be between the ages of 20 and 40 years old and generally healthy.
A detailed explanation of the study procedures, potential risks, and benefits will be provided. Participants will have the opportunity to ask questions and provide informed consent.
Step 2
Vaccination
Participants will receive a **pneumococcal vaccine**. The vaccine is administered as a **suspension for injection** using an **intramuscular injection** method. The specific vaccines used are **Apexxnar** and **Prevenar 13**.
The injection will be given in a healthcare setting by a qualified professional.
Step 3
Follow-up visits
Participants will attend several follow-up visits. During these visits, samples will be collected from the lymph nodes and blood to study the immune response to the vaccine.
The primary focus is to determine the timing of peak **germinal center B cell** frequency in lymph node samples. Additional analyses will include the study of **T follicular helper cells** and other immune cells.
Step 4
Final assessment
At the end of the study period, a final assessment will be conducted. This will include a review of all collected data and a discussion of any findings related to the participant's immune response.
Participants will be informed about the overall results of the study once it is completed.

Who can join the trial?

4 criteria

Participants must be between the ages of 20 and 40 years old.
Participants should be generally healthy and without significant other health issues. This includes not having any auto-immune diseases that are being actively treated with medications that suppress the immune system.
Participants with chronic diseases that do not need medications to suppress the immune system and are stable might be eligible. Stable means not needing a change in treatment or hospitalization in the six weeks before joining the study.
Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

Participants must be healthy volunteers. This means you should not have any ongoing medical conditions.
Participants must be within a specific age range, which is typically defined by the study.
Both male and female participants are eligible.
Participants should not be part of a vulnerable population. This generally refers to groups who may need special protection, such as children, pregnant women, or those unable to give consent.

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Responsive
Academisch Ziekenhuis Leiden
Leiden, The Netherlands

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Investigated drugs

Pneumococcal Vaccine is a type of vaccine designed to protect against infections caused by the bacteria Streptococcus pneumoniae. This bacteria can cause serious illnesses such as pneumonia, meningitis, and bloodstream infections. The vaccine works by stimulating the body's immune system to recognize and fight the bacteria if exposed in the future. In this clinical trial, the vaccine is used to study how the immune system responds, particularly focusing on the activity of certain immune cells in the lymph nodes.

What is already known about the treatment

The provided data does not specify any particular medication name or details about a specific medication being tested in the clinical trial. Therefore, I am unable to create a description for a medication based on the given information. If you have a specific medication name or additional details, please provide them for a more accurate description.

Investigated diseases

Healthy volunteers – This term refers to individuals who do not have any known medical conditions or diseases. They are typically used in clinical trials to provide baseline data for comparison with individuals who have specific health conditions. Healthy volunteers help researchers understand the normal progression of biological processes. They do not exhibit symptoms of the diseases being studied. Their participation is crucial for determining the effects of new treatments or interventions. Healthy volunteers are essential for ensuring the safety and efficacy of medical research.