A study to assess the safety and effectiveness of malaria vaccine candidates (VAC044)
VOLUNTEER INFORMATION AND REGISTRATION
REC REF: 11/H0604/2
A Phase Ia Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination with the Candidate Malaria Vaccines; AdCh63 AMA1, MVA AMA1 & AMA1-C1/Alhydrogel® +/- CPG 7909
Chief Investigator: Professor Adrian V.S. Hill DM FRCP
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital, Oxford OX3 7LJ
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 Registration form below and a member of the study team will contact you to provide you with more information and arrange a screening appointment, at which point you would have the opportunity to discuss the study in more detail.
What is the purpose of this study?
Malaria affects around 300 million people each year about a 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, 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. Over the last 10 years, we have been conducting clinical studies of new malaria vaccines.
The purpose of this study is to examine the safety and immune response to three new malaria vaccines; AdCh63 AMA1, MVA AMA1 and AMA1-C1/Alhydrogel® +/- CPG 7909, administered in various combinations. All three of these vaccines have been used previously in clinical trials; however they have demonstrated only limited ability to prevent malaria. It is hoped that by combining the different vaccines in various schedules we can improve the effectiveness of the vaccines.
AdCh63 AMA1 and MVA AMA1 are vaccines that are made from viruses which are inactivated so that they are unable to multiply within the body. The viruses contain genetic information (DNA) from the malaria parasite. This genetic material is named AMA1. The aim is to use these vaccines to help the body make an immune response against parts of the malaria parasite. The AdCh63 AMA1 vaccine is based on a weakened version of an adenovirus (a common cold virus). The strain of adenovirus we use for this vaccine usually affects chimpanzees. The MVA AMA1 vaccine is based on the Modified Vaccinia Virus Ankara (MVA), which is a safer form of the vaccine virus previously widely used for smallpox vaccination.
AMA1-C1/Alhydrogel® is a vaccine developed at the Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, USA. The ‘AMA1-C1’ part of this vaccine is a protein similar to a malaria parasite protein. AMA1-C1 has been mixed with Alhydrogel®, a material that is commonly added to vaccines to make them work better (also called an adjuvant). Some individuals in this study will also receive AMA1-C1/Alhydrogel® mixed with another adjuvant called CPG 7909 that has been shown to increase the body’s immune response to a vaccine.
The purpose of this study is to test new vaccination schedules, using these vaccines but changing the timing and sequence in which the vaccines are administered.
This study will enable us to assess:
1. The safety of the vaccine schedules in healthy volunteers.
2. The response of the human immune system to different vaccine schedules.
We will do this by giving volunteers two or three vaccinations and doing blood tests to assess the response of the immune system to the vaccines. We hope to recruit 36 volunteers to be vaccinated.
Can I Take Part?
To take part you need to be in good health and aged between 18 and 50 years. 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. Your participation in this study is at the researchers’ discretion.
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 interested in taking part, we will send you a detailed information sheet for the trial and arrange for you to come for a screening appointment.
