Study on the Safety and Immune Response of V116 Vaccine for Pneumococcal Disease in Adults Aged 50 and Older

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What is this study about?

This clinical trial is focused on studying a disease called pneumococcal disease, which is caused by bacteria that can lead to infections in the lungs, blood, and brain. The study is testing a new vaccine called the Pneumococcal 21-valent Conjugate Vaccine, also known by its code name V116. This vaccine is designed to protect against 21 different types of the bacteria that cause pneumococcal disease. The study will compare the effects of V116 with another vaccine called PPSV23, which is already used to prevent pneumococcal disease.

The purpose of the study is to evaluate the safety and effectiveness of V116 in adults aged 50 years or older who have not previously received a pneumococcal vaccine. Participants will receive an injection of either V116 or PPSV23. The study will monitor participants for any side effects and measure their immune response to the vaccine. This will help determine how well the vaccine works in producing antibodies, which are proteins in the blood that help fight infections.

Participants will be followed for a period of time to observe any reactions to the vaccine and to measure the levels of antibodies in their blood. The study aims to see if V116 can provide better protection against pneumococcal disease compared to the existing vaccine. The results will help in understanding the potential benefits of using V116 for preventing infections caused by pneumococcal bacteria in older adults.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study is designed to evaluate the safety and effectiveness of a new vaccine called V116 for preventing pneumococcal disease in adults aged 50 years or older.

2 initial assessment

An initial assessment will be conducted to ensure you meet the study criteria. This includes reviewing your medical history, menstrual and recent sexual activity history if applicable, to ensure there is no early undetected pregnancy.

3 vaccination

You will receive an injection of the Pneumococcal 21-valent Conjugate Vaccine as a solution for injection. The vaccine will be administered intramuscularly, which means it will be injected into a muscle.

4 monitoring for side effects

After receiving the vaccine, you will be monitored for any side effects. This includes checking for any reactions at the injection site or any systemic reactions, which are reactions that affect the whole body.

5 follow-up visits

You will have follow-up visits to assess your response to the vaccine. These visits will include blood tests to measure your immune response to the vaccine, specifically looking at the levels of antibodies produced against the pneumococcal bacteria.

6 final assessment

A final assessment will be conducted to evaluate the overall safety and effectiveness of the vaccine. This will include a review of any side effects experienced and the results of your immune response tests.

Who Can Join the Study?

Participants must have a medical condition related to Pneumococcal disease.
Participants can be of any gender.
Participants must be within the age range of 18 to 49 years old.
For females, they must not be pregnant or breastfeeding. If they are of childbearing potential, they must use acceptable contraception or abstain from sexual activity. Their medical, menstrual, and recent sexual activity history will be reviewed to ensure there is no early undetected pregnancy.

Who Cannot Join the Study?

Participants who have had a severe allergic reaction to any component of the vaccine.
Individuals with a history of severe allergic reactions to any vaccine.
People who have received another vaccine within 30 days before the study starts.
Participants who are currently participating in another clinical trial.
Individuals with a weakened immune system, which means their body has a harder time fighting infections.
People who have a serious illness or infection at the time of enrollment.
Participants who are pregnant or planning to become pregnant during the study period.
Individuals with a history of drug or alcohol abuse that might interfere with their ability to follow the study procedures.
People who have received blood products or immunoglobulins within the last 3 months.
Participants with any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fundacion De Oftalmologia Medica De La Comunitat Valenciana	Valencia	Spain

Other Sites

Site Name	City	Country
Equip D’atencio Primaria Barcelona Sardenya S.L.P.	Barcelona	Spain
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital Universitario De Getafe	Getafe	Spain
Eap Osona Sud Alt Congost S.L.P.	Centelles	Spain
Medizentrum Essen Borbeck	Essen	Germany
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Cxe Vianryzr	Barcelona	Spain
Unegefrntu Hmjguyvh Ctdiifn	Cologne	Germany
Urownmcddw Mcjuuoe Cbosrj Hivixiygbdwodhyqp	Hamburg	Germany
Hiibjzpp Utqfwljautycw Dd Lo Pmtcprmh	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	18.11.2022
Spain	Not recruiting	18.11.2022

Trial locations

Investigated drugs:

V116 is a new vaccine being tested in this clinical trial. It is designed to protect against pneumococcal disease, which is caused by a type of bacteria that can lead to serious infections like pneumonia. The trial is focused on understanding how safe and well-tolerated this vaccine is in adults who are 50 years or older and have not previously received a pneumococcal vaccine. The study also aims to see how well the vaccine works by measuring the body’s immune response to it.

PPSV23 is an existing vaccine that is already used to protect against pneumococcal disease. It is being used in this trial as a comparison to the new vaccine, V116. The goal is to compare the immune response generated by V116 to that of PPSV23, especially looking at specific types of bacteria that V116 targets. This helps researchers understand if V116 might offer better or different protection compared to the current standard vaccine.

Pneumococcal disease – Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae. It can lead to various illnesses, including pneumonia, meningitis, and bacteremia. The disease often begins with symptoms such as fever, chills, and cough, which can progress to more severe conditions depending on the site of infection. In the case of pneumonia, it can cause difficulty breathing and chest pain. If it progresses to meningitis, symptoms may include a stiff neck, headache, and confusion. The disease spreads through respiratory droplets, making it contagious, especially in crowded environments.

Trial ID:

2022-503144-40-00

Protocol code:

V116-010-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of V116 Vaccine for Pneumococcal Disease in Adults Aged 50 and Older

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?