Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

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What is this study about?

This clinical trial studies the immune system response to pneumococcal vaccines in different groups of people, including young healthy adults, older adults, and people living with HIV. The study will examine how two different types of pneumococcal vaccines – Prevenar 20 and Pneumovax 23 – affect the formation of special structures in lymph nodes called germinal centers, which are important for immune system function.

The study involves taking small samples from lymph nodes and blood to analyze how the immune system responds to vaccination. Participants will receive a single dose of one of the pneumococcal vaccines through an intramuscular injection. The researchers will monitor the immune response for up to 6 months after vaccination by collecting blood samples and small amounts of saliva.

The research aims to understand how factors like age and HIV infection influence the body’s response to different types of vaccines. This knowledge could help improve vaccination strategies for different groups of people. The study will also look at how lifestyle factors such as diet, exercise, and smoking might affect the immune response to vaccination.

1 Initial vaccination

You will receive one of two pneumococcal vaccines: either Prevenar 20 or Pneumovax 23.

The vaccine will be administered as an intramuscular injection.

2 7-day follow-up

A blood sample will be collected to analyze serum biomarkers.

A sample from your lymph node fluid will be collected for analysis.

3 4-week assessment

At 28 days after vaccination, your lymph nodes will be examined using ultrasound to measure their size.

A small sample of lymph node fluid will be collected to study immune cell formation.

Blood samples will be taken to analyze serum biomarkers.

4 10-week follow-up

At day 72 after vaccination, additional blood samples will be collected.

Your lymph node fluid will be analyzed again.

5 6-month final assessment

Blood samples will be collected to analyze your immune response to the vaccine.

A saliva sample will be collected to check for pneumococcal bacteria.

This marks the completion of your participation in the study.

Who Can Join the Study?

You must be either between 20-40 years old OR over 60 years old
You must be in generally good health
Both men and women can participate
If you are living with HIV:
- You must be between 20-40 years old
- You must have documented HIV infection
- You must be currently taking anti-retroviral therapy (medications that treat HIV)
- Your viral load must be less than 200 copies per milliliter (this means the HIV virus is well-controlled in your body)

Who Cannot Join the Study?

Active infections or fever (temperature above 38°C/100.4°F) at the time of vaccination
Previous severe allergic reactions to any pneumococcal vaccines or their components
Receipt of any vaccine within 30 days before study enrollment
Current participation in another clinical trial
Pregnancy or breastfeeding
History of severe allergic reactions or anaphylaxis to any medications
Any condition that, in the opinion of the investigator, would make participation unsafe
Use of immunosuppressive medications (drugs that weaken the immune system)
Bleeding disorders or use of blood thinners
Any serious chronic medical condition that is not well-controlled
History of autoimmune disease (conditions where the immune system attacks healthy body tissues)
Recent blood transfusion or receipt of blood products within the last 3 months
Current substance abuse or alcoholism
Mental conditions that would interfere with study compliance
Unable to follow study procedures or attend follow-up visits

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Lfmab Utxbpoxjxvzf Molffit Cddhzqa (mgqbj	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2024

Trial locations

Investigated drugs:

Based on the provided trial data, there is only one type of intervention mentioned:

Pneumococcal vaccine – This is a vaccine that helps protect against Streptococcus pneumoniae bacteria (pneumococcus). These bacteria can cause serious infections like pneumonia, meningitis, and bloodstream infections. The vaccine works by stimulating the immune system to produce antibodies that can fight against pneumococcal bacteria. This trial studies how different groups of people respond to the vaccine by examining their lymph nodes.

Note: The specific type or brand of pneumococcal vaccine is not mentioned in the provided data.

Investigated diseases:

HIV infection

HIV infection – A viral infection that affects the immune system by targeting CD4+ T cells, which are crucial for fighting off infections. The virus gradually weakens the body’s natural defenses by reducing the number of these important immune cells. HIV infection progresses through several stages, during which the virus continues to multiply and affect more immune cells. The condition affects the body’s ability to respond effectively to various pathogens and can make people more susceptible to other infections. Over time, without intervention, the virus leads to a progressive decline in immune function. The infection can be transmitted through specific bodily fluids, including blood, breast milk, and during sexual contact.

Pneumococcal infection – A bacterial infection caused by Streptococcus pneumoniae that can affect various parts of the body. The bacteria can colonize the upper respiratory tract and potentially spread to other areas. The infection commonly begins in the sinuses or lungs but can also affect other body parts. The bacteria can be present in the body without causing illness, a state known as colonization. The infection is more common in people with weakened immune systems and can spread between people through respiratory droplets.

Trial ID:

2023-510354-16-00

Protocol code:

2023-510354-16-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?