Jenner

Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Oxford OX3 7LJ

Chief Investigator:
Professor Adrian V.S. Hill DM FRCP

E-mail: vaccinetrials@well.ox.ac.uk

Tel: +44 1865 857401

VOLUNTEER INFORMATION AND PRE-REGISTRATION

A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria

We would like to invite you to take part in a research study. Before you decide you need to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully. Talk to others about the study if you wish.

Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. If you wish to take part, please fill in the Pre-registration form below and a member of the study team will contact you to arrange an appointment, at which point you would have the opportunity to discuss the study in more detail. If you wished to take part and no other exclusion criteria were identified you would then be able to be enrolled in the study.

Information

What is the purpose of the study?

Malaria affects around 300 million people each year, about 1 million of whom die from the disease. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe and effective malaria vaccine. Researchers around the world, including members of Professor Hill’s group at Oxford University, have been investigating malaria for over 15 years. Professor Hill’s group has been conducting clinical studies of experimental malaria vaccines since 1999.

The purpose of this study is to test a new experimental vaccine against malaria in healthy volunteers to see if the vaccine helps protect against malaria infection. The vaccine (AMA1-C1/Alhydrogel® + CPG 7909) has been developed at the Malaria Vaccine Development Branch, National Institutes of Health, USA. In earlier studies, the antibodies which some volunteers made after receiving this vaccine were able to prevent the malaria parasite from multiplying in the laboratory.

In this study, we will vaccinate volunteers and then infect them with malaria (“challenge”) by an injection of infected red blood cells from a donor in order to assess if the vaccine slows or prevents malaria infection in healthy volunteers. The donor of the red blood cells infected with malaria has previously had infection with 2 common viruses; Epstein Barr Virus (EBV) and Cytomegalovirus (CMV). These viruses can cause flu-like or tonsillitis symptoms. Once somebody has caught these viruses, they are immune to the virus for life. The blood donor was positive for antibodies to both these viruses, so we will only include you in this study if you are also positive to both viruses.

Can I take part?

To take part you need to be in good health, aged between 18 and 50 years and have antibodies to EBV & CMV. Mild conditions, such as childhood asthma which is well controlled, would not automatically exclude you from participating. Women who are pregnant or who are trying to become pregnant, or who are breast-feeding should not take part in this study. You should be able to comply with all of the study requirements
and be able to attend all of the follow up visits.

It is up to you to decide whether or not to take part. You are free to withdraw at any time, for any reason, and without any adverse consequences for you if you decide to withdraw.

If you agree to take part you will be invited to a pre-screening visit at which you will be asked to sign a consent form and then a 5ml blood sample will be taken to test for the presence of antibodies to EBV & CMV. If a stored blood sample is available we may not need to take additional blood at the pre-screening visit, but will test the stored sample for EBV and CMV antibodies with your consent. We will contact you with the results of the test and invite you back for a full screening visit if you have antibodies to EBV & CMV.

Pre-registration form

Required fields *

Your Details

First name*
Middle Name
Surname*
Date of Birth*	(Must be aged 18 to 50 years)
Contact Email Address*
Contact Phone Number*

Please click 'submit' here if you wish to send these details to the study site. Sending this information does NOT commit you to taking part in the study. A member of the study team would then contact you to arrange an appointment, at which point you would have the opportunity to discuss the study in more detail. If you wished to take part and no other exclusion criteria were identified you would then be able to be enrolled in the study.