Update on Reducing Acquisition of CMV through antenatal Education (RACE-FIT) February 2020
CMV Action has been delighted to be involved in the RACE-FIT project - to develop an educational intervention to reduce the risk of acquiring CMV infection in pregnancy, co-designed with pregnant women and families affected by CMV. Phase I of the project has now been completed. Messages from interviews with families affected by CMV informed the storyline of a moving educational film and significantly contributed to final product.
Phase II of the project has been concerned with the recruitment of women to take part in the study, with 3795 pregnant women approached to participate. The study specifically looked for women believed to be most at risk of contracting the virus – those in their second, or subsequent pregnancy, with another child or children under the age of four. 95% of pregnant women ‘at risk of CMV’ were willing to have CMV serology tested; the original assumption was 70%, so this was a fantastic result.
Following serology testing, women who tested seronegative - the cohort required for the study - and who agreed to take part were recruited to RACE-FIT. Work on this stage will be completed and analysed by May 2020 and the team hope to submit a final report for publication in the summer of this year.
A further funding application has been submitted to follow up on this important work to the National Institute of Health Research (NIHR) and we are pleased to report that the application has passed its first stage. The proposed research will be a 12-month project to establish and build effective partnerships with policy makers and stakeholders to identify policy priorities and to gather the essential evidence needed to fully inform policies to reduce the risk of CMV infection in pregnancy, and if successful, should commence in July this year.
We will bring you further news of the results of the RACE-FIT study, and the NIHR funding application as soon as they are available. Many congratulations to everyone involved for all the hard work and great results achieved to date.
CMV Action are delighted to be taking part in the UK research project “Reducing Acquisition of CMV through antenatal Education (RACE-FIT)” which aims to assess an educational intervention to reduce the risk of catching cytomegalovirus (CMV) infection in pregnancy.
CMV is the most common infection to be contracted before birth and about 20% of babies infected with CMV in this way will have permanent health problems, such as hearing loss, learning delay or physical impairments. Simple hygiene measures may reduce the risk of catching CMV whilst pregnant, and therefore, also the risk of passing on the infection to the unborn baby. In the UK, pregnant women are not routinely told about these hygiene measures.
Before we can embark on a large-scale study to determine the effectiveness of an education intervention in reducing CMV infection in pregnancy, the feasibility of such a large study has to be assessed. Doctors at St. Georges University of London, in partnership with CMV Action, are working together with experts from Kingston University, University College London and Cambridge University to develop and educational material. The study has been funded by the National Institute for Health Research (NIHR) and approved by the NHS Research Ethics Committee.
To date, phase I of the project has been completed. In the first phase interviews and focus groups with pregnant women and families affected by CMV were conducted. This helped the team to understand the levels of knowledge about CMV amongst pregnant women and how messages about reducing the risk of catching CMV are best delivered. Families who have a child affected by CMV and responded to our call to take part, generously shared their stories of how CMV has affected their child and their family. These experiences were instrumental in shaping the narrative for the production of a film, which is now being tested in a randomised controlled trial to understand if this can increase knowledge and understanding about CMV and whether it is effective at helping women to modify their behaviour to try to reduce the risk of catching CMV infection in pregnancy. Women who are having antenatal care at St George’s Hospital are being asked if they would like to take part in the trial.
There have been two promising phase II trials into a vaccine for CMV. One trial (Pass et al 2009) was undertaken in adolescent and young adult women with a particularly high risk of acquiring primary CMV infection (e.g. a substantial proportion had a toddler at home) . The study found that a glycoprotein B (gB) vaccine gave 50% protection against acquiring a primary CMV infection for those who had not been infected before. These suggest that a gB vaccine may be able to prevent congenital CMV transmission in women of childbearing age.
However one of the main complications in developing a vaccine is the fact that congenital CMV infection does not just occur when a woman catches CMV for the first time when pregnant. It can also occur if she has pre-existing immunity but then catches a new strain of the virus. A further phase II study on glycoprotein B vaccine was carried out on transplant patients (Griffiths et al. 2011). The results of this trial were significant because it increased protection against CMV infection in those who had never had a strain of CMV before (seronegative) and those who had previously caught a different strain of the virus (seropositive).