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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.
Angela
Minassian
angela.minassian@bioch.ox.ac.uk
Fay
Nugent
fay.nugent@paediatrics.ox.ac.uk
Jee-Sun
Cho
jee-sun.cho@bioch.ox.ac.uk
Nelly
Owino
nelly.owino@paediatrics.ox.ac.uk
Protozoal diseases
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. There is a great need for a safe,effective malaria vaccine and the team at University of Oxford is trying to make vaccine(s) which can prevent serious illness and death.
This study is being done to assess an experimental malaria vaccine for its ability to prevent malaria illness. This is done using a ‘blood-stage challenge model’. This is when volunteers are infected with malaria parasites using malaria-infected red blood cells.
The vaccines we are testing in this part of the study are called "RH5.1" and “RH5.2-VLP”. They will be given with an adjuvant called “Matrix-M” which is a substance that improves the body’s response to a vaccination. RH5.1 is a protein vaccine. It has been used in two previous trials and given to over 100 volunteers and has been shown to be safe and well tolerated in these trials. It has also been shown to make a good immune response and slow down the rate of malaria infection. RH5.2-VLP is being tested for the first time in humans in this trial. The Matrix-M adjuvant has been given to tens of thousands of people,with no major concerns,such as illness.
The aim is to use this vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:
The safety of the vaccine in healthy participants.
The response of the human immune system to the vaccine.
The ability of the vaccine to prevent malaria illness (Group 2 only).
We will do this by giving healthy adult participants (aged 18-45) three of the vaccines and/or expose participants to malaria infection at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM),Churchill Hospital in Oxford. We will then do blood tests and collect information about any symptoms that occur after vaccination. There will be 19 to 54 visits,lasting between 3 months to 2 years and 2 months.
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:
Interventional type: Vaccine;
You can take part if:
You may not be able to take part if:
The volunteer may not enter the study if any of the following apply: • History of clinical malaria (any species) or previous participation in any malaria (vaccine) trial or CHMI • Travel to a clearly malaria endemic locality during the study period or within the preceding six months • Use of immunoglobulins or blood products (e.g. blood transfusion) in the last three months • 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 vaccination • Receipt of an investigational product in the 30 days preceding enrolment,or planned receipt during the study period • Concurrent involvement in another clinical trial involving an investigational product or planned involvement during the study period • Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data,as assessed by the Investigator • 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) • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine • Any history of anaphylaxis in reaction to vaccinations • Pregnancy,lactation or intention to become pregnant during the study • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) • History of serious psychiatric condition that may affect participation in the study • Any other serious chronic illness requiring hospital specialist supervision • Suspected or known current alcohol misuse as defined by an alcohol intake of greater than 25 standard UK units every week • Suspected or known injecting drug use in the 5 years preceding enrolment • Hepatitis B surface antigen (HBsAg) detected in serum • 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) • Volunteers unable to be closely followed for social,geographic or psychological reasons. • Any clinically significant abnormal finding on biochemistry or haematology blood tests,urinalysis or clinical examination. The normal range of results for each blood parameter is shown in Table 12 (Appendix A). In the event of abnormal test results,confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria are described in Appendix A. • 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 data • Inability of the study team to contact the volunteer’s GP to confirm medical history Additional exclusion criteria for Groups 2 and 6: • Body weight <50 kg or Body Mass Index (BMI) <18.0 at screening • Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole,doxycycline,tetracycline,clindamycin,erythromycin,fluoroquinolones and azithromycin) • Use of anti-malarials within 30 days of CHMI • Receipt of a COVID-19 vaccine within 2 weeks before the day of CHMI or planned receipt of a COVID-19 vaccine or prior to expected completion of antimalarial treatment (around 2 to 3 weeks after day of challenge based on experience in previous P. falciparum CHMI studies to date) • An estimated ten-year risk of fatal cardiovascular disease of ≥5% at screening,as determined by the Systematic Coronary Risk Evaluation (SCORE). • Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone • Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone • Any other contraindications/known hypersensitivities to both Riamet and Malarone • Any clinical condition known to prolong the QT interval • History,or evidence at screening,of clinically significant arrhythmias,including clinically relevant bradycardia,prolonged QT interval or other clinically relevant ECG abnormalities • Disturbances of electrolyte balance,e.g. hypokalaemia or hypomagnesaemia • Family history of congenital QT prolongation or sudden death • Positive family history in both 1st AND 2nd degree relatives < 50 years old for cardiac disease •History of sickle cell anaemia,sickle cell trait,thalassaemia or thalassaemia trait,G6PD deficiency or any haematological condition that could affect susceptibility to malaria infection
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Nelly
Owino
nelly.owino@paediatrics.ox.ac.uk
Jee-Sun
Cho
jee-sun.cho@bioch.ox.ac.uk
Angela
Minassian
angela.minassian@bioch.ox.ac.uk
Fay
Nugent
fay.nugent@paediatrics.ox.ac.uk
The study is sponsored by University of Oxford and funded by United States Agency for International Development .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 56870
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