2009 H1N1 Influenza Clinical Trial
Official title:
Evaluation of the Effect of Age and Prior Immunity on the Response to Live or Inactivated A/California/07/09 H1N1 Influenza Vaccines in Children
A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV separated by 28 days. Children with prior vaccination or natural infection with novel H1N1 influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.
The study will be conducted as a randomized, prospective, open-label evaluation of the
clinical tolerability, vaccine virus shedding, and serum and mucosal antibody response to
vaccination with either live monovalent novel H1N1 influenza vaccine (LAIV) or monovalent
inactivated novel H1N1 influenza vaccine (IIV) in healthy children between the ages of 4 and
9 years. Children will be screened for antibody to A/Brisbane/57/07 (H1N1) and
A/California/07/09 (H1N1) prior to randomization. Children with evidence of prior exposure
to the 2009 pandemic H1N1 virus will be excluded. Those with antibodies to A/Brisbane/57/07
(H1N1) will be stratified by preexisting antibody. Vaccine will be administered on days 0
and 28.
Safety of vaccination will be assessed using symptoms collected by parents for 7 days after
each dose of vaccine. Serum will be obtained prior to and on day 28 following each dose of
vaccine and assessed for antibody by HAI, ELISA, B-cell ELISPOT and neutralization
techniques. Nasal secretions will be obtained by nasal aspiration prior to and on day 28
after each dose and assessed for HA-specific IgA antibody by ELISA. Nasal swabs will be
obtained on days 2, 4, and 7 after each dose of live vaccine and assessed for the presence
and magnitude of vaccine virus shedding of the live attenuated vaccine by rtRT-PCR and
TCID50 on MDCK cells.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment