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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Angela Minassian
+44 (0)1865 611400
angela.minassian@paediatrics.ox.ac.uk


Dr Ruth Payne
+44 (0)114 2159535
r.o.payne@sheffield.ac.uk


Miss Rachel Cowan
+44 (0)1865 611400
rachel.cowan@paediatrics.ox.ac.uk


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Be Part of Research - Trial Details - A study to compare two dosing regimens for a new malaria vaccine
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A study to compare two dosing regimens for a new malaria vaccine

Not Recruiting

Open to: All Genders

Age: Adult

Sheffield

Medical Conditions

Malaria (African strain)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe, effective malaria vaccine. This study is being done to evaluate an experimental malaria vaccine for its safety. We will also look at the body’s immune response to the vaccine. The vaccine being tested in this study is called RH5.1. This is given with an adjuvant called “Matrix-M”. This is a substance to improve the body’s response to vaccination. The aim is to use vaccines and adjuvants to help the body make an immune response against parts of the malaria parasite. This study will assess the safety of the vaccines in healthy participants and the response of the human immune system to the vaccines.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Jun 2023 28 Feb 2024

Participants are given three doses of the RH5.1 vaccines at two different dose levels (10 and 50 micrograms; μg). One group will have three doses of 10 μg given at 0, 1 and 6 months whilst the other will receive two doses of 50 μg (at 1 and 2 months) followed by a 10 μg dose at 6 months - known as a 'delayed fractional dose'. The researchers will then do blood tests and collect information about any symptoms that occur after vaccination.


Healthy adults aged 18 to 50 years

You can take part if:



You may not be able to take part if:


1. History of clinical malaria (any species) or previous participation in any malaria (vaccine) trial or controlled human malaria infection (CHMI) study2. Travel to a clearly malaria endemic locality during the study period or within the preceding 6 months3. Use of immunoglobulins or blood products (e.g. blood transfusion) in the last 3 months4. Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination5. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period6. Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period7. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator8. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)9. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine 10. Any history of anaphylaxis 11. Pregnancy, lactation or intention to become pregnant during the study12. Body mass index of <18.5 or >3513. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)14. History of serious psychiatric condition that may affect participation in the study15. Any other serious chronic illness requiring hospital specialist supervision16. Suspected or known current alcohol misuse as defined by an alcohol intake of greater than 25 standard UK units every week17. Suspected or known injecting drug use in the 5 years preceding enrolment18. Hepatitis B surface antigen (HBsAg) detected in serum19. Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV ribonucleic acid (RNA) PCR at screening for this study)20. Volunteers unable to be closely followed for social, geographic or psychological reasons.21. Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria are shown in SOP VC02722. Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data23. Inability of the study team to contact the volunteer’s GP to confirm medical history and safety to participate


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF

Information from previous studies suggests that a delayed fractional dose improves the immune response to the vaccine, particularly in terms of the antibody response. The researchers suspect that this improvement is due to the delay in dosing, rather than the reduction in dose, and this study will help to answer that. Having a vaccine at a single dose is important for efficient production and dosing for vaccines rolled out in national programs so being able to move away from 'delayed fractional dose' regimens to 'delayed final dose' regimens will be important for vaccine development.
The amount of blood taken at each visit will vary between around 14 ml (about 3 teaspoons) to a maximum of 86 ml (about 6 tablespoons). The volume of blood being taken over the course of the trial should not cause any problems in healthy people. There may be some temporary mild discomfort, including bruising and tenderness at the site where the blood is taken. Participants may feel faint as a result of collecting blood. Blood will be collected by trained staff and participants will be able to lie down for blood tests if necessary.
If abnormal results or undiagnosed conditions are found in the course of the study these will be discussed with participants and with their agreement the participant's GP may also be informed.
The most common side effects experienced by participants who have previously received RH5.1/Matrix-M are described below.
We expect that most symptoms will be mild. However, some may be moderate or severe. All symptoms should resolve completely within a few days. Participants may experience any of the following side effects:
Injection site pain is most likely mild. However, there is a chance this could be moderate or severe in intensity.
Redness, swelling, itching and warmth at the vaccine site. Symptoms are likely to be mild if present. However, there is a chance this could be moderate or severe in intensity.
A ‘flu-like’ illness within 24 hours of vaccination which usually resolves within 48 hours. This can include headache, muscle aches, joint aches, feverishness, tiredness, nausea and feeling generally unwell. The majority of general symptoms are likely to be mild. There is a possibility of moderate or severe symptoms occurring.
With any vaccination, there is a low risk of serious reactions. These may be related to the nervous system or the immune system.
Severe allergic reactions to vaccines (anaphylaxis) are very rare but can be fatal. The researchers will have doctors qualified in the management of anaphylaxis at each vaccination. Appropriate equipment and medication will also be present.
Reactions in the nervous system are also extremely rare. However, vaccines can cause an illness called Guillain-Barré syndrome. This is an illness in which people can develop severe weakness. It may be fatal. However, these reactions have not previously been seen with the type of vaccine used in this study.
Study doctors will be available 24 hours a day in the adverse event follow-up period post-vaccination, and participants will be encouraged to contact them if concerned.
We now have over 2 years of experience conducting trials during the COVID-19 pandemic. We have developed protocols to keep our volunteers safe and trials running. As the public health situation evolves, we may change some of these procedures, in line with the most up-to-date guidance from the UK Health Security Agency (UKHSA) and the UK Government. To minimise the number of people in the building during study visits, we will give participants a specific appointment time for all study visits.

Miss Rachel Cowan
+44 (0)1865 611400
rachel.cowan@paediatrics.ox.ac.uk


Dr Ruth Payne
+44 (0)114 2159535
r.o.payne@sheffield.ac.uk


Dr Angela Minassian
+44 (0)1865 611400
angela.minassian@paediatrics.ox.ac.uk



The study is sponsored by University of Oxford and funded by Medical Research Council.



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Read full details for Trial ID: ISRCTN95289709

Or CPMS 55207

Last updated 23 May 2025

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