The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human.
- Conditions
- Influenza
- Registration Number
- JPRN-UMIN000007461
- Lead Sponsor
- ational Institute of Infectious Diseases
- Brief Summary
Haemagglutination inhibition (HI) and neutralization (NT) titres as well as haemagglutinin (HA) specific antibody responses were examined in 50 healthy adults aged between 22 and 69 years old after two intranasal administrations of an inactivated A/Victoria/210/2009 whole virus vaccine (45 ug HA per dose) at 3 week intervals. Serum HI titres after two-doses of the nasal vaccine showed >2.5-fold rise in the ratio of geometric mean titre upon vaccination, >40% of subjects with a >4-fold increase in titre and >70% of subjects with a titre of >1:40, all parameters associated with an effective outcome of vaccination in the criteria defined by the European Medicines Agency. Serum neutralizing antibody responses correlated with HI antibody responses, although NT titres were about two-fold higher than HI titres. These high levels of serum responses were accompanied by high levels of HI and neutralizing antibody responses in nasal mucus as measured in concentrated nasal wash samples that were about 10 times diluted compared to natural nasal mucus. Serum and nasal HI and neutralizing antibody responses consisted of HA-specific IgG and IgA antibody responses, with IgG and IgA antibodies being dominant in serum and nasal responses, respectively. Hum Vaccin Immunother. 2013 Sep 1;9(9):1962-70. doi: 10.4161/hv.25458.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1. Volunteers with a fever at the time of planned vaccination. 2. Volunteers with serious acute diseases. 3. Volunteers considered inappropriate to be inoculated vaccine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eutralization, HI, and HA-specific antibody titers before and after intranasal vaccination. Survey on side reaction after vaccination.
- Secondary Outcome Measures
Name Time Method