Delivering a vaccine against an emerging pandemic flu strain requires developers to make a lot of quick decisions about dosing, use of adjuvants and other factors. With H7N9, however, China's success in limiting the virus' spread has given other countries more time to prepare.
The United States' NIH is taking advantage by running two trials to assess Sanofi's ($SNY) H7N9 vaccine in conjunction with adjuvants from GlaxoSmithKline ($GSK) and Novartis ($NVS). Up to 1,700 participants across the two trials will receive the Sanofi vaccine at a variety of doses, either without an adjuvant, or with different combinations of GSK's AS03 and Novartis' MF59. By the time the trials finish in December 2014, NIH hopes to have a clearer picture of how the immune system responds to the vaccine and adjuvants.
"We're studying how much active ingredient we need to put into the vaccine and if we can accelerate the process with a substance that improves the immune response," Group Health Research Institute (GHRI) senior investigator Dr. Lisa Jackson said. Jackson is leading the second trial, in which up to 1,000 participants will be assigned to 10 groups. Each arm will receive a different regimen of Sanofi's jab and the adjuvants. The other trial will split participants into 7 groups, 5 of which will receive the vaccine along with Novartis' MF59 adjuvant.
Europeans have received AS03 and MF59 as part of seasonal and pandemic flu vaccines, but both have been involved in controversies over the past year. Novartis' adjuvanted seasonal flu vaccine, Fluad, was briefly banned in several countries over concerns about protein aggregation. The ban was lifted quickly after independent tests confirmed the safety of the vaccine. GSK, however, is still dealing with concerns about its adjuvant, which studies have linked to increased risk of narcolepsy. In November a FDA panel unanimously endorsed a GSK H5N1 vaccine containing AS03, but a final decision was delayed because of an 'administrative matter.'
- read the NIH release
- check out the GHRI news