All studies
Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Durability of protection after single immunisation with genetically attenuated Plasmodium falciparum ∆mei2 (GA2) sporozoites – a follow-up, controlled human malaria rechallenge study

Researchers are conducting a study to understand how long a new type of malaria vaccine, called GA2, can protect people from getting sick. This vaccine is given as a single shot. After vaccination, participants will be carefully exposed to malaria parasites under strict medical supervision to see if they are still protected. This is a follow-up study on people who previously received this vaccine. The main aim is to assess how long the immunity provided by a single dose of the GA2 vaccine lasts. It's an important step in developing effective new ways to prevent falciparum malaria, a serious disease prevalent in many parts of the world.

At a glance

Status
Ongoing, recruiting
Phase
Phase I and Phase II (Integrated)- Other
Sponsor
Leids Universitair Medisch Centrum (LUMC)
Enrolment target
14
Start
07 Oct 2024

What is this study about?

This research is looking into a new way to protect people from a very serious illness called falciparum malaria. Malaria is caused by tiny parasites spread by mosquito bites and can make people very sick, sometimes even leading to death. Finding effective ways to prevent it, like vaccines, is extremely important.

Specifically, this study is testing a special kind of vaccine, known as GA2. What's unique about GA2 is that it uses a weakened form of the malaria parasite itself, not just parts of it. The idea is that by introducing this weakened parasite, your body learns to fight off the real thing without getting you seriously ill. This particular study wants to find out how long a single dose of this GA2 vaccine can keep you safe from malaria.

To do this, after people have received the vaccine, scientists will carefully and safely expose them to malaria parasites in a controlled environment. This is called a "human malaria rechallenge" study. It allows researchers to precisely see if the vaccine is still working and how effective it is over time. The information gathered from this study will help us understand if this vaccine could be a long-lasting solution in the fight against malaria.

Key takeaways

  • This study is testing a new single-dose malaria vaccine (GA2).
  • It aims to see how long the vaccine protects against falciparum malaria.
  • Participants will be intentionally (and safely) exposed to malaria to test the vaccine's effectiveness.
  • It's a follow-up study for adults who previously received the vaccine.
  • The findings could help develop better malaria prevention tools.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. The study welcomes both men and women.

While the raw information is brief, it implies that beyond being an adult of any gender, there would be other health checks. Typically, studies like this look for people who are generally healthy, don't have certain long-term health conditions, and aren't taking specific medications that could interfere with the study.

It's also important to note that this is a follow-up study, meaning it's likely looking for people who previously participated in an earlier part of the GA2 vaccine research.

Quick self-check
  • Am I 18 years old or older?
  • Have I participated in a previous GA2 vaccine study?
  • Do I have any serious ongoing health conditions?
  • Am I willing to have regular blood tests and medical check-ups?
  • Am I available for multiple clinic visits over a period of time?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve several visits to a clinic or research facility. You would first have screening appointments to make sure you are healthy enough and meet all the study requirements. If eligible, you would receive the single dose of the vaccine (if you haven't received it previously as part of a related study).

After vaccination, there would be a period of time where your health is monitored. Then, you would undergo a 'controlled human malaria rechallenge,' which means you would be intentionally exposed to malaria parasites under medical supervision. This is done in a very controlled way to ensure your safety. Throughout the study, you would have regular check-ups, blood tests, and other assessments to monitor your health and how your body reacts to the vaccine and the malaria challenge. The total duration of your participation, including follow-up, would be clearly explained by the research team.

Potential risks and benefits

Participating in this study could potentially help advance the development of a new malaria vaccine, which could save many lives globally. However, there are potential risks, including side effects from the vaccine itself, and the risk of developing malaria symptoms after the intentional exposure, even though it's carefully monitored. You would be treated quickly if you develop malaria. You have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Netherlands

Common questions

What is falciparum malaria?

Falciparum malaria is a severe form of malaria, a serious disease caused by parasites spread through mosquito bites. It can make people very ill and, if not treated quickly, can be life-threatening.

What does 'genetically attenuated' mean for a vaccine?

It means the malaria parasite used in the vaccine has been weakened or changed in a lab so it can't cause serious illness. It's designed to teach your body to fight off the real, stronger parasite.

Why would I be exposed to malaria in the study?

This controlled exposure, called a 'human malaria rechallenge,' allows researchers to directly see if the vaccine has successfully protected you from getting sick with malaria and how long that protection lasts. It's done under strict medical supervision for your safety.

Will I get paid to participate?

Often, clinical trials offer payment for time and travel, but this varies. The research team will provide full details about any compensation if you are considering joining.

Is this vaccine approved for general use?

No, this is a research study (Phase I and Phase II), meaning the vaccine is still being tested and is not yet available to the general public. It's a key step in seeing if it can become an approved vaccine.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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