VAC085 Trial. Transmission Blocking Vaccine
The purpose of this study, which is being hosted at the Jenner Institute, is to assess the safety of
Pfs48/45 in Matrix-M, as well as the body’s immune response to the vaccine. This will be
administered in healthy volunteers aged 18-45 years.
The vaccine aims to cause the body to produce an immune response which blocks the malaria
parasite developing in the mosquito, so that when the mosquito next bites, it cannot infect another
person with malaria.
This means that unlike other vaccines, Pfs48/45 in Matrix-M does not aim to protect the person
being vaccinated from disease but instead to reduce risk of infection to other people. In this way,
if effective, a transmission-blocking vaccine could stop onward transmission of malaria and bring
down the number of cases in the whole population.
Am I eligible to participate?
What does the trial involve?
This takes place at The Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) at The Churchill Hospital, Oxford and will last approximately two hours. The purpose of the screening visit is for you to discuss the trial with us and decide if you wish to enter the study. If you decide to participate, you will be asked to sign a consent form and we will check that you are eligible to participate.
After signing the consent form:
- You will be asked some medical questions.
- A doctor will examine you.
- Blood samples and a urine sample will be taken. These tests will need to be normal for you to be enrolled in the study.
- All women will have a urinary pregnancy test.
You will receive 3 vaccinations and attend 16 visits in total. All visits will take place at the Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) in Oxford.
Each vaccination is given four weeks apart (on days 0, 28 and 56). Volunteers will be reviewed in clinic the day after each of the three vaccinations and then at one week, two weeks and four weeks post-vaccination.
In addition to this there are 2 further clinic appointments, on days 140 and 240 after the third vaccination. This means that the final clinic review will be approximately 8 months after the first vaccine dose.
Follow up visits and symptom tracking
You will be asked to fill in an electronic diary card to tell us about any symptoms you have after vaccination and will be required to have blood tests taken at most of the follow-up visits.
Is there any reimbursement for the trial?
Yes, you will be reimbursed at set rates for your time, inconvenience and travel which for this study will be approximately £790.
What are the advantages of taking part?
This study will not benefit you, but the information gained from the study might help to prevent malaria infection and disease in those living in areas where malaria is common and in travellers to those areas. At present, there is no transmission-blocking malaria vaccine approved anywhere in the world. There are other malaria vaccines in various stages of development. This study may help develop an effective transmission-blocking malaria vaccine.
What are the risks of taking part?
This particular vaccine has not been used in humans before but we do not expect the side effects of this vaccine to be significantly different from previous trials we have conducted using similar vaccines.
Please refer to the trial information sheet for full details of procedures and potential risks.
What will happen if I don’t want to carry on with the study?
If, at any time after agreeing to participate, you change your mind about being involved with this study you are free to withdraw without giving a reason. Your decision will not result in any penalty, or loss of benefits to which you are otherwise entitled. Unless you state otherwise, any blood taken whilst you have been in the study will continue to be stored and used for research as detailed above. Similarly, all your data collected up to the point of your withdrawal will be stored, unless you specifically request for it to be destroyed. You are free to request that your blood samples are destroyed at any time during or after the study.
For more details about the study, please read the full participant information sheet.