Study on the Safety and Immune Response of Meningococcal B Vaccine in Adults Without a Spleen

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What is this study about?

This clinical trial is focused on studying the effects of a vaccine called Bexsero in adults who have had their spleen removed, a condition known as asplenia. The vaccine is designed to protect against a type of bacteria called Neisseria meningitidis group B, which can cause serious infections. The study aims to see if the vaccine works as well in people without a spleen as it does in healthy individuals.

Participants in the study will receive the Bexsero vaccine through an injection into the muscle. The study will involve two vaccinations, and the main focus is to measure the body’s immune response one month after the second vaccination. This will be done by checking the levels of protective antibodies in the blood. The study will also look at how long these antibodies last and will monitor any side effects that may occur after receiving the vaccine.

The goal of the study is to ensure that the vaccine provides adequate protection for people with asplenia, as they are at a higher risk for infections. The study will compare the immune response of these individuals to that of healthy people to determine if the vaccine is equally effective in both groups. Participants will be observed for any adverse events, and their immune response will be assessed through various tests.

1 joining the study

Upon joining the study, ensure that you meet the eligibility criteria, which include being between 18 to 60 years of age and having asplenia due to splenectomy or functional asplenia.

If you are female, a negative urine pregnancy test result is required at the start of the study, and you must agree to use adequate birth control measures for the duration of the study.

Provide written informed consent to participate in the study.

2 first vaccination

Receive the first dose of the Bexsero vaccine, which is a suspension for injection administered via intramuscular injection.

This vaccine is designed to protect against meningococcal serogroup B.

3 second vaccination

Approximately one month after the first vaccination, receive the second dose of the Bexsero vaccine.

This second dose is also administered as an intramuscular injection.

4 one month follow-up

One month after the second vaccination, a blood test will be conducted to measure the level of antibodies in your blood.

This test helps to assess the immune response to the vaccine.

5 six months follow-up

Six months after the second vaccination, another blood test will be conducted to evaluate the persistence of antibodies.

This test will also measure the cellular immune response, including lymphocyte proliferation and cytokine levels.

6 monitoring for adverse events

Throughout the study, any adverse events, which are unexpected medical occurrences, will be monitored and recorded.

These events will be evaluated for their severity and potential relation to the vaccination.

Who Can Join the Study?

  • Must have asplenia, which means not having a working spleen, either because it was removed (splenectomy) or it doesn’t function properly.
  • Must be between 18 to 60 years of age.
  • If you are a female, you must have a negative urine pregnancy test at the start of the study and agree to use adequate birth control during the study.
  • Must provide written informed consent, which means you agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

  • Patients who have had a splenectomy cannot participate. A splenectomy is a surgery to remove the spleen, an organ that helps fight infections.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.01.2024

Trial locations

BEXSERO® is a vaccine designed to protect against infections caused by a type of bacteria known as meningococcal serogroup B. This vaccine works by helping your body build its own defense system, known as the immune system, to fight off these bacteria. In this clinical trial, the vaccine is being tested to see how well it works in people who do not have a spleen, compared to those who do. The spleen is an organ that helps fight infections, so people without a spleen may have a different response to the vaccine. The goal is to ensure that the vaccine is just as effective in these patients as it is in healthy individuals.

Splenectomy – Splenectomy is not a disease but a surgical procedure involving the removal of the spleen. The spleen is an organ that plays a role in filtering blood and supporting the immune system. After the spleen is removed, the body may become more susceptible to infections, as the spleen helps fight certain bacteria. The absence of the spleen can lead to changes in blood cell counts, particularly affecting red blood cells and platelets. Over time, other organs, such as the liver, may partially compensate for the loss of the spleen’s functions. Patients who have undergone splenectomy may require vaccinations and other preventive measures to reduce the risk of infections.

Trial ID:
2023-508192-36-00
Protocol code:
MenB_Asplenia
NCT ID:
NCT06025487
Trial Phase:
Therapeutic exploratory (Phase II)

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