AVIS (Acute Virus Immunity Study)
Research type
Research Study
Full title
HUMAN IMMUNE RESPONSES TO ACUTE AND EMERGING VIRUS INFECTIONS
IRAS ID
202413
Contact name
Lance Turtle
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Flaviviruses are a family of closely related viruses that include the most important insect-borne viruses to infect humans. Dengue virus, Japanese encephalitis (JE) virus, yellow fever virus, West Nile virus and, most recently Zika virus are all examples of flaviviruses. These viruses all cause millions of illnesses and tens of thousands of deaths every year worldwide. Zika virus is now suspected of causing severe birth defects in South America. While some have vaccines available, many do not and developing them has been challenging.\n\nA vaccine for Zika is urgently needed. The main aim of this work is to establish whether available vaccines could offer protection against Zika in pregnancy. In general, one flavivirus does not give protection to another (so called “cross-reactive” protection), but there is evidence of a period of short term cross-reactive protection. Because the problem with Zika appears to be the first three or four months of pregnancy, short term protection like this might be very useful and at least could help to bridge the gap while a dedicated Zika vaccine is developed.\n\nThis study will look at neutralisation of Zika virus in culture in people having JE vaccine and tick borne encephalitis (TBE) vaccine. In addition to this, we will study immune responses in subjects having infection with other flaviviruses in detail. This is because the responses are highly cross-reactive, infection with one virus leads to immune responses to many. By studying natural infection as well as vaccination, we hope to identify sections of virus that, in a vaccine, could provide protection against many viruses in a single shot. By aiming for broad protection, we could be much better prepared for the emergence of another new flavivirus. COVID-19 amendment – 23/04/2020] In late 2019 a novel coronavirus emerged in Hubei Province, China, which is currently causing a global pandemic of a disease now known as COVID-19. Many of the original questions posed by this work on Zika are equally applicable to COVID-19, and our laboratory is poised to answer many critical questions. For the time being, the lab has completely switched over to working on COVID 19. The Flavimmune study has collected a cohort of volunteers initially with the aim of studies on flaviviruses, but with permission included for re-contact for future work in other areas. Samples have been collected and stored on many of the participants, all of which pre-date the emergence of COVID-19. This has now become and incredibly precious\nresource, this will allow us to perform experiments on SARS-CoV-2 using control samples that cannot possibly have responses arising from exposure to SARS-CoV-2. Therefore, this amendment proposes the following changes:\n1. Use of existing stored samples for experiments on COVID-19, such as assessing new diagnostic tests, and establishing T cell assays for SARS-CoV-2\n2. Use of newly collected samples and new recruits for the same purposes\nThe previous version of the study protocol and information given to volunteers anticipated this kind of need, and volunteers were told they may be asked for permission for further experiments beyond flaviviruses. The wording used in the PIS was: “We would like your permission to do other experiments on these stored samples in the future. This would only mean looking at factors which are involved in fighting off flaviviruses. We cannot say now all the experiments we might do because new things might be discovered in the future that we would want to investigate. “We would like to allow other researchers who also have ideas about flaviviruses to apply to use your samples for the same thing in the future too. We would like your permission now to do these kinds of experiments so we don’t have to\nask you again in the future. “If we wanted to do tests for anything else, we would have to ask you first. Any future experiments not related to\nflaviviruses would be approved by a research ethics committee. If you don’t want your samples stored that’s fine, you can still take part in the rest of the study, we just won’t keep your samples at the end. Or if you are happy with having your samples stored, but not sent to another lab, you can choose this as well.“\nTherefore, provision was built in to do other things beyond flaviviruses, but only with the knowledge and consent of the donor. Donors have also given specific permission to be re-contacted. Therefore, we will re-contact all those participants who have consented to this for permission to use their samples for COVID research.\nThis was approved by chairs action on 2nd April and volunteers were contacted the same day. The responses indicated a high level of willingness for samples to be re-used in this way. Also, significant approval and encouragement was voiced by many volunteers that we had switched over to tackling the COVID pandemic.\nSome serum samples have already been used to show that one of the new antibody tests for COVID is highly specific (manuscript submission is expected the week of 14-18 April 2020). Consent has been obtained from existing donors for this work by email. Given the current Government advice against unnecessary travel, we not propose to ask the volunteers to physically sign a new consent form. We have kept a written and electronic record of which donors have given consent - we will only use samples from these volunteers who have responded (the overwhelming majority). We are not asking for any additional samples, nor are we expecting anything else different from our volunteers. We feel that asking them to ravel to come in and sign another consent form places them at a small, but nevertheless unnecessary, risk. Therefore, we propose to manage this consent process entirely by email.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0170
Date of REC Opinion
8 Mar 2016
REC opinion
Favourable Opinion