Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

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What is this study about?

This clinical trial is focused on studying a disease called Pneumococcal infection, which is caused by bacteria that can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The study is testing a new vaccine called V116, which is designed to protect against this infection. The trial will also compare the effects of V116 with other vaccines, specifically PCV15 and PPSV23. Participants in the study will receive either the new vaccine or a placebo, which is a substance with no active ingredients, to help researchers understand the vaccine’s safety and effectiveness.

The purpose of the study is to evaluate how safe and well-tolerated the V116 vaccine is, as well as how well it works in producing an immune response in adults aged 18 to 64 who are at increased risk for pneumococcal disease. This includes individuals with conditions like diabetes, chronic liver disease, chronic obstructive pulmonary disease (COPD), asthma, chronic heart disease, and chronic kidney disease. The study will monitor participants for any side effects and measure their immune response to the vaccine over a period of time.

Participants will be randomly assigned to receive either the V116 vaccine or the other vaccines being studied. They will receive the vaccine through an injection into the muscle. The study will track any reactions at the injection site, as well as any other side effects, for a few days after vaccination. Additionally, the study will measure the levels of specific antibodies in the blood, which are proteins that help fight infections, to see how well the vaccine works in boosting the immune system. The study aims to provide valuable information on the potential benefits of the V116 vaccine for preventing pneumococcal infections in people who are more vulnerable to this disease.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific health conditions such as diabetes, chronic liver disease, or chronic heart disease.

Your medical history will be reviewed, and you will be asked to provide informed consent to participate in the study.

2 first vaccination

You will receive the first dose of the V116 vaccine through an intramuscular injection. This means the vaccine will be injected into a muscle.

You will be monitored for any immediate reactions to the vaccine.

3 monitoring period

For the first five days after vaccination, you will be asked to report any side effects, such as pain at the injection site or other symptoms.

You will be required to attend follow-up visits to monitor your health and the vaccine’s effects.

4 second vaccination

Approximately 12 weeks after the first vaccination, you will receive a second dose, which may be a different vaccine called PCV15 + PPSV23.

This dose will also be administered via intramuscular injection.

5 final monitoring

You will continue to be monitored for any side effects or reactions for a specified period after the second vaccination.

Your immune response to the vaccines will be evaluated through blood tests to measure specific antibodies.

6 study completion

Once all follow-up visits and evaluations are completed, your participation in the study will conclude.

You will receive information about the study’s findings and any relevant health advice.

Who Can Join the Study?

The patient must have at least one of the following risk conditions for pneumococcal disease:
- Diabetes mellitus: A condition where the body has trouble managing blood sugar levels. The patient should be on at least one approved diabetes medication, and all blood sugar tests (Hemoglobin A1c) should be 9% or lower in the last 6 months.
- Compensated chronic liver disease: A liver condition that is stable and managed.
- Chronic obstructive pulmonary disease (COPD): A lung condition that makes it hard to breathe, managed according to local guidelines.
- Mild or moderate persistent asthma: A lung condition causing breathing difficulties, managed according to local guidelines.
- Chronic heart disease: A heart condition that is confirmed and managed according to local guidelines.
- Chronic kidney disease: A kidney condition lasting more than 3 months.
The patient must be receiving stable medical treatment for the above conditions for at least 3 months, with no major changes in treatment expected during the study, and no more than one hospital stay related to the condition.
The patient must be between 18 and 64 years old at the time of giving consent to participate in the study.
If the patient is a female who can have children, she must use an acceptable method of birth control or choose not to have vaginal intercourse as a regular lifestyle choice. Her medical and menstrual history, as well as recent sexual activity, should be reviewed by the study investigator.

Who Cannot Join the Study?

Participants who have had a severe allergic reaction to any vaccine in the past.
Individuals with a weakened immune system, which means their body has a harder time fighting infections.
People who are currently receiving treatment that affects the immune system, such as chemotherapy for cancer.
Participants who have received any other vaccine within the last 30 days.
Individuals with a history of bleeding disorders, which are conditions that affect the way blood clots.
Pregnant or breastfeeding women.
Anyone who has participated in another clinical trial within the last 30 days.
Individuals with a history of drug or alcohol abuse within the past year.
People with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Pratia S.A. Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Poland

Other Sites

Site Name	City	Country
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Pratia S.A.	Skorzewo	Poland
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Clinical Medical Research Sp. z o.o.	Katowice	Poland
Mnukmxufu Icvgtvuodv Ckrsguku Smfpmfxh Sky z odkc	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	17.04.2023

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 an infection caused by bacteria that can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The trial is focused on understanding how safe and well-tolerated this vaccine is for adults who have never received a pneumococcal vaccine before and are at increased risk for these infections. The study also looks at how well the vaccine works by measuring the body’s immune response to it.

PCV15 is a pneumococcal conjugate vaccine that is already used to protect against pneumococcal disease. It works by helping the immune system recognize and fight off the bacteria that cause these infections. In this trial, PCV15 is used as a comparison to see how the new vaccine, V116, performs in terms of safety and immune response.

PPSV23 is another type of pneumococcal vaccine that is used to protect against a broader range of pneumococcal bacteria. It is often given to adults to help prevent serious infections. In this study, PPSV23 is used in combination with PCV15 to compare the immune response and safety of the new vaccine, V116, against this established vaccination regimen.

Pneumococcal infection – Pneumococcal infection is caused by the bacterium Streptococcus pneumoniae. It can lead to various illnesses, including pneumonia, meningitis, and bacteremia. The infection typically begins when the bacteria colonize the upper respiratory tract. From there, it can spread to other parts of the body, causing more severe diseases. The progression of the infection depends on the site affected and the individual’s immune response. Symptoms can range from mild respiratory issues to severe complications affecting the brain or bloodstream.

Trial ID:

2022-502791-22-01

Protocol code:

V116-008

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

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