US: H1N1 vaccine trials on children soon

The Safety Monitoring Committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of the candidate novel H1N1 vaccine,which began on August 7,and found no safety concerns,the NIAID said on its website.

Of the two trials of the vaccine to be done now on children,one will investigate the immune response to two different strengths of the vaccine manufactured by Sanofi Pasteur. Led by the VTEU at the University of Maryland,Baltimore,the trial will enroll up to 650 children,between the ages of six months and 17 years,at five locations. Immune responses will be measured following doses of either 15 micrograms or 30 micrograms of the vaccine on the first visit and a second dose three weeks later.

The second trial,led by the VTEU at Saint Louis University,will test administration of a seasonal influenza vaccine along with the candidate novel H1N1 vaccine. It will be conducted at the University and five other US locations. It will assess the candidate vaccine’s safety and how immune responses vary when the novel H1N1 vaccine is given before,after,or at the same time as the seasonal vaccine.

Initial results on how the immune system responds to the vaccine are expected in the next few weeks,the NIAID said.