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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
caroline
kingdon
caroline.kingdon@lshtm.ac.uk
Dr
Eliana
Lacerda
eliana.lacerda@lshtm.ac.uk
Provisional assignment of new diseases of uncertain etiologyOther disorders of the nervous system
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Members of the human herpesvirus (HHV) family have been implicated in ME/CFS onset and/or symptom exacerbation, but different studies have yielded contradictory results. In a pilot study, we observed a correlation between saliva HHV-6B DNA concentration and symptom severity. It is not known whether ME/CFS pathogenesis leads to HHV reactivation, or whether HHV reactivation causes the symptoms associated with ME/CFS.
This proposed study seeks to address causality, by assessing salivary HHV viral load though time, alongside frequent (weekly) assessment of symptoms, to determine whether HHV-6B reactivation or symptom exacerbation occurs first. We also propose to investigate abnormalities in the anti-HHV-6B immune response in people with ME/CFS.
This proposed research is, to our knowledge, the first study to investigate the role of HHV reactivation in a large cohort of people with ME/CFS and two control groups. We aim to: i) test the association between HHV-6B DNA concentration and severity of ME/CFS symptoms, and to determine the temporal relationship between the two variablesÍľ ii) confirm if there is systemic virus reactivation, by comparing the concentration of HHV-6B DNA in saliva and blood, alongside protein and RNA markers of viral reactivation, and iii) compare the anti-HHV-6B immune response, particularly the T cell and antigen presenting cell function, in people with ME/CFS compared to healthy controls. Inclusion of people with Long COVID who fit the diagnostic criteria for ME/CFS will enable us to assess immune function in an antigen-specific manner in people with relatively recent ME/CFS onset, compared to people who recovered quickly from a Sars-CoV-2 infection.
Our data will enable us to determine whether HHV-6B reactivation occurs prior to ME/CFS relapse, meaning it might be causative, and will yield insight into potential immunological abnormalities in ME/CFS enabling reactivation, which may lead to future treatment developments for ME/CFS and Long COVID.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
ME/CFS cases: unable to give informed consent, history of acute and chronic infectious diseases such as hepatitis B and C, tuberculosis, HIV (but not herpesvirus or other retrovirus infection); other severe illness including major psychiatric illness. Pregnant women and those within 12 months post-partum and/or currently lactating will also be excluded. Healthy controls: all the above, plus the presence of any fatiguing illnesses and other conditions that would exclude a diagnosis of ME/CFS (in those with fatigue) present or past. Long Covid cases: unable to give informed consent, history of acute and chronic infectious diseases such as hepatitis B and C, tuberculosis, HIV (but not herpesvirus or other retrovirus infection); other severe illness including prior diagnosis of ME/CFS, major psychiatric illness; current pregnancy or within 12 months post-partum and/or currently lactating. Recovered SARS-CoV-2 infection cases: all the above.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by London School of Hygiene and Tropical Medicine and funded by National Institute of Allergy and Infectious Diseases (NIH NIAID) .
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Read full details
for Trial ID: CPMS 55360
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