EML-Vac
Research type
Research Study
Full title
A first-in-human clinical trial to assess the safety and immunogenicity of three self-amplifying ribonucleic acid (saRNA) vaccines against encoding the surface glycoprotein of Ebola virus, Marburg virus and Lassa virus (EML-Vac)
IRAS ID
1012266
Contact name
Marta Boffito
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN11364585
Research summary
EMLVAC is a study that is looking at new RNA vaccines against the Marburg, Ebola and Lassa Fever viruses which and
are the major causes of viral bleeding (heamorrhagic) fever. The aim of the study is to assess the safety of these vaccines alone
and in combination, since this will be the first time that these have been used in humans. But this trial is NOT looking
at whether the vaccines are effective in terms of protection. It is just assessing whether and how well the
immune system responds to the vaccine.Since this is the first time these vaccines have been used in humans, the safety will be assessed in healthy young
adults. 40 participants aged 18-50 years will be randomised to one of five different groups receiving either Ebola,
Marburg or Lassa self-amplifying RNA (saRNA) vaccines individually or in combination by injection into the muscle.
Participants will receive prime and boosting immunisations 12 weeks apart. They will be careful monitoring for any
reactions to the vaccine.Participants will be asked to record any symptoms in an online diary. To see how well the immune system is
responding, participants will need to give blood samples several times during the first 6 weeks; then for weeks 12-16
following their boosted immunization immunisation and finally at 24, 36 and 52 weeks to assess durability of
response. This study will take place at one study centre.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0596
Date of REC Opinion
19 Sep 2025
REC opinion
Further Information Favourable Opinion