A clinical study to assess the immunogenicity and safety of a monovalent 2009 influenza A (H1N1) vaccine in an area with low-level epidemics of pandemic influenza

We conducted a multi-center, randomized, laboratory-blinded clinical trial in 185 healthy adults (60 years) to examine the immunogenicity and safety of different doses of an inactivated, monovalent, non-adjuvanted, split vaccine against the 2009 pandemic influenza A (H1N1) virus. The 186 adults were assigned to three treatment groups, i.e., one 15μg hemagglutination (HA) antigen dose, two 15μg or 30μg HA doses in 3 weeks apart, and the 107 elders were treated with two 15μg or 30μg doses in 3 weeks apart. Prior to the vaccination, 4.8% subjects had hemagglutination-inhibition (HAI) antibody titers of 1:40 or more. By day 21 post-vaccination of one dose of 15μg HA, the seroprotective rate was 95.1% and 75.5% in subjects 65 years of age, respectively; by day 21 post the second 15μg HA dose, the seroprotective rates were 93.2% and 73.1%, respectively. The seroprotective rates for recipients of 30μg HA antigen by day 21 were 95.2% for subjects 65 years of age, that was boosted to 98.3% and 80.4%, respectively with a second dose of 30μg HA antigen. No vaccine-related serious adverse events occurred. The data indicated a single 15μg HA dose of the vaccine induced a protective immune response in most adults, including the elders >60 years of age, and a booster dose at the third week did not render a higher level of antibody response.