BIO-001 Trial: Malaria Vaccine Study

A study to assess the safety and effectiveness of an experimental malaria vaccine (BIO-001/ CVIA 099)

You are invited to take part in a challenge study to investigate whether a novel vaccine can prevent malaria. The study is being run by the Oxford Vaccine Group in partnership with the Department of Biochemistry which is part of the University of Oxford and is funded by PATH.

If you are aged 18 to 45 years old, in good health and live in the Oxford area, then you may be eligible to take part in the study. All participants will be reimbursed for their time, inconvenience and travel up to £1,880.The total study participation time is 18-26 months.

Background

Malaria is a major global 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 as the range of malaria medicines is limited and drug resistance is increasing. Researchers around the world, including at the University of Oxford, have been investigating malaria vaccines for many years.

There is currently no widely available and consistently effective vaccine against malaria and we are trying to make a vaccine which is better at preventing serious illness and death. In this study, we hope to see if an experimental vaccine can protect against P. falciparum and to understand the immune response which may be important in preventing disease. We hope that the knowledge gained from this trial will help in the development of vaccines and make Malaria a preventable disease.

Study information

The vaccines we are testing in this study are called “RH5.2-VLP” and “RH5.1”.  They are given with an adjuvant called “Matrix-M”. This is a substance to improve the body’s response to a vaccination. We will be giving volunteers three doses of vaccine by injection into the muscle of the upper arm. After each vaccination, we will see volunteers in clinic at regular intervals to assess for side effects and take blood samples to analyse the body’s immune response to the vaccines.

After the third vaccination, we will see volunteers for further follow-up visits until 1-2 years after the final vaccination.

Further information on the vaccines and study groups can be found in the study information sheet (link to PIS for BIO-001).

The Oxford Vaccine Group, University of Oxford, is based in the Centre for Clinical Vaccinology and Tropical Medicine at the Churchill Hospital site.

Further Information

If you would like to find out more, please read the Study Information Booklet and if you are interested in joining the study, please visit https://trials.ovg.ox.ac.uk/trials/bio-001 where you can access the screening questions and register your interest.

If you would like any further information regarding the study, please contact us on:

Email info@ovg.ox.ac.uk, Tel: 01865 611400