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
Journal
Vaccine
Journal Volume
28
Journal Issue
45
Pages
7337-7343
Date Issued
2010
Author(s)
Kao T.-M.
Lee Y.-C.
Chang F.-Y.
Wang N.-C.
Liu Y.-C.
Lee W.-S.
Liu H.-J.
Chen C.-I.
Chen C.-H.
Abstract
We conducted a multi-center, randomized, laboratory-blinded clinical trial in 185 healthy adults (<60 years) and 107 elders (>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 <60 and >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 <60 years and 81.1% 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. ? 2010 Elsevier Ltd.
SDGs
Other Subjects
influenza vaccine; adult; aged; antibody response; antibody titer; article; chemotherapy induced emesis; chest tightness; clinical trial; controlled clinical trial; controlled study; coughing; dizziness; drug fever; drug safety; ecchymosis; eye disease; face edema; female; headache; hemagglutination; hemagglutination inhibition; human; immune response; immunogenicity; influenza A (H1N1); influenza vaccination; Influenza virus A H1N1; limb movement; major clinical study; malaise; male; multicenter study; myalgia; nausea; nose congestion; pain; pandemic influenza; phase 2 clinical trial; priority journal; respiratory distress; respiratory tract infection; side effect; single blind procedure; sore throat; swelling; Adult; Aged; Aged, 80 and over; Antibodies, Viral; Antibody Formation; Epidemics; Female; Hemagglutination Inhibition Tests; Hemagglutinin Glycoproteins, Influenza Virus; Humans; Influenza A Virus, H1N1 Subtype; Influenza Vaccines; Influenza, Human; Male; Middle Aged; Taiwan; Vaccination; Young Adult
Type
journal article