Immunogenicity of the influenza vaccine post RIC allograft
Research type
Research Study
Full title
A pilot study comparing the microneutralization assay and haemagglutination inhibition assay as measures of the immunogenicity of seasonal inactive influenza vaccine in recipients of reduced intensity conditioning allogeneic haematopoietic stem cell transplants during the first year post-transplant
IRAS ID
183540
Contact name
Alejandro Madrigal
Contact email
Sponsor organisation
University College London (UCL)
Clinicaltrials.gov Identifier
15/0470, UCL Research and Development Number
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Allogeneic haematopoietic stem cell transplant (HSCT) is a curative treatment option for a number of haematological disorders. Patients treated with allogeneic HSCT are at a high risk of infection, and infection related complications from the seasonal influenza virus. The primary intervention for preventing seasonal influenza infection is annual vaccination with the inactivated influenza vaccine (IIV). International guidelines recommend annual administration of a single dose of IIV to patients treated with allogeneic HSCT aged over 6 months old, starting 6 months after the date of HSCT. This guidance is based principally on evidence from studies investigating patients treated with full intensity (myeloablative) conditioning (MAC) chemotherapy before transplant, and using the Haemagglutination Inhibition (HI) assay to quantify antibody levels following vaccination.
Across Europe the number of patients treated with reduced intensity conditioning (RIC) chemotherapy before transplant has increased from 1426 to 5567 between 2000 and 2011. Over 50% of HSCT patients in the United Kingdom received RIC. The aim of this study is to investigate how this specific group of HSCT patients respond to the IIV in the first year post transplant. The study will measure and compare antibody response to IIV using two assays; the standard HI assay and the viral microneutralization (MN) assay, which has been shown to be more sensitive to antibodies to pandemic H1N1 virus, and to influenza B strains, both of which are included in the 2015-2016 IIV for the Northern Hemisphere.
The aim of this pilot study is to compare the number of seroconversions (a fourfold increase in antibody titre) detected by the two assays. The second aim is to find out whether seroconversions are detectable before 6 months in this group of patients. The final aim of the study is to provide data to help design and power larger studies in the future.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0394
Date of REC Opinion
12 Aug 2015
REC opinion
Favourable Opinion