AuthorisedPhase III and phase IV (Integrated)Interventional

MENPI: Safety and immunogenicity following meningococcal and pneumococcal immunization among adult people living with HIV. A single center, non-blinded, randomized clinical trial

This study, called MENPI, is investigating certain vaccines for adults living with HIV. Specifically, it's looking at vaccines that help protect against serious infections like meningitis and pneumonia. The main goal is to understand how safe these vaccines are for people with HIV and how well their immune systems respond to them. This involves checking if the vaccines create a strong protective reaction in the body. The study is a clinical trial, which means it carefully compares different approaches to see which works best. This research is important because it could lead to better ways to keep people with HIV healthy and reduce their risk of catching these particular infections.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Hvidovre Hospital

Enrolment target

Start

11 Oct 2024

HIV

What is this study about?

This research study, known as MENPI, is all about understanding how well certain important vaccines work for adults who are living with HIV. We're specifically looking at vaccines that protect against two serious infections: meningococcal disease (a type of meningitis) and pneumococcal disease (which can cause pneumonia). These infections can be more severe for people with weakened immune systems, like those with HIV, so finding good ways to prevent them is really important.

The study wants to find out two main things: first, how safe these vaccines are for people living with HIV, and second, how well their body's defence system (their immune system) reacts to the vaccines. A good reaction means the body builds up protection against the germs. By studying this, doctors can learn more about the best ways to keep people with HIV healthy and protect them from these illnesses.

This is a clinical trial, which is a carefully planned medical study. It's being conducted at one hospital, and participants will be randomly assigned to different groups. This helps scientists compare the effects of the vaccines fairly. The findings from this research could help shape future health guidelines and ensure that people living with HIV receive the best possible protection against these infections.

Key takeaways

Tests safety and effectiveness of meningitis and pneumonia vaccines for adults with HIV.
Aims to improve preventative care for people living with HIV.
Involves regular clinic visits and blood tests if you participate.
Participation is voluntary, and you can withdraw at any time.
Could help scientists find better ways to protect people with HIV from infections.

Who may be eligible?

This study is looking for adults who are living with HIV to take part. To be considered, you need to be at least 18 years old – there's no upper age limit, so older adults are welcome too. Both men and women can participate in this research.

There might be other specific health checks or criteria that the study team will need to go through with you to make sure it's safe and appropriate for you to join. This is standard practice in all medical studies to protect your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you living with HIV?
Are you comfortable with regular hospital visits and blood tests?
Are you interested in contributing to medical research for HIV care?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you're suitable. Once enrolled, you'll receive the study vaccines. The study team will then monitor your health and how your body reacts to the vaccines over a period of time. This will involve several visits to the study clinic, where you might have blood samples taken to see your immune response and answer questions about how you're feeling. They will also look for any side effects. The total duration of your participation, including follow-up, will be explained in detail by the study team, but typically these types of studies involve several visits over a few months or even longer.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving important vaccinations and contributing to medical knowledge that could help others living with HIV. However, there are also potential risks involved, which are carefully explained to you before you agree to participate. These might include common vaccine side effects like soreness at the injection site or a mild fever, or very rarely, more serious reactions. You will be closely monitored, and your safety is the priority. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is the main purpose of this study?

The study aims to see how safe vaccines for meningitis and pneumonia are for adults with HIV, and how well their immune system responds to them.

Who can join this study?

Adults aged 18 and over, of any gender, who are living with HIV can be considered.

Will I have to pay to be part of the study?

No, your participation in the study, including any vaccines or tests, will not cost you anything.

What side effects might I experience?

Like any vaccine, you might have mild side effects such as soreness, swelling, or redness where you got the injection, or feel a bit feverish. Serious side effects are rare.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it will not affect your usual medical care.