LAIV-HIV study
Research type
Research Study
Full title
Exploring novel mechanisms of vaccine failure and induction of pulmonary immunity following live attenuated influenza vaccination in HIV-infected and uninfected individuals: a pilot study.
IRAS ID
155866
Contact name
Thushan de Silva
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2014-001924-31
Research summary
Influenza can cause severe infections, especially in those with weakened immune systems such as those with HIV. For this reason, yearly vaccination is recommended with the standard ‘inactivated’ influenza vaccine to try and prevent infections in these populations. It is also recommended in all health care workers, to help prevent the spread of influenza in the health care environment. However, having HIV infection may mean vaccines work less well in some people and we do not completely understand why. An alternative to the standard ‘inactivated’ annual influenza vaccine is the ‘live attenuated influenza vaccine’ (LAIV), which means it consists of weakened versions of the influenza virus. Unlike the standard vaccine, which is given by injection, LAIV is a nasal spray and is now given as a preference to the vaccine to children in the UK as it results in greater protection from influenza. A few studies in the past have shown that LAIV is safe and effective in HIV-infected children and adults.
The study proposes to give LAIV to HIV-infected and HIV negative individuals, to try and find out new information about how HIV infection may change the way in which people respond to vaccines. This will be done by comparing both the early genetic response to the vaccines and later responses from cells specifically targeted to fight influenza (T-cells), in these groups. In the long-term, the research team hope that the study will lead to designing new ways of improving the response to vaccines in HIV-infected people. As LAIV is given into each nostril, rather than by injection, we also want to see if LAIV results in T-cells in the lung that are specifically targeted to fight influenza.
This is a case-control, interventional, laboratory study which has been designed primarily as a pilot study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0177
Date of REC Opinion
15 Jul 2014
REC opinion
Further Information Favourable Opinion