tetano
Editor, Senior Moderator
Vaccine. 2010 Sep 1. [Epub ahead of print]
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.
Kung HC, Huang KC, Kao TM, Lee YC, Chang FY, Wang NC, Liu YC, Lee WS, Liu HJ, Chen CI, Chen CH, Huang LM, Hsieh SM.
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
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 15mug hemagglutination (HA) antigen dose, two 15mug or 30mug HA doses in 3 weeks apart, and the 107 elders were treated with two 15mug or 30mug 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 15mug 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 15mug HA dose, the seroprotective rates were 93.2% and 73.1%, respectively. The seroprotective rates for recipients of 30mug 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 30mug HA antigen. No vaccine-related serious adverse events occurred. The data indicated a single 15mug 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.
PMID: 20817013 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20817013
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.
Kung HC, Huang KC, Kao TM, Lee YC, Chang FY, Wang NC, Liu YC, Lee WS, Liu HJ, Chen CI, Chen CH, Huang LM, Hsieh SM.
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
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 15mug hemagglutination (HA) antigen dose, two 15mug or 30mug HA doses in 3 weeks apart, and the 107 elders were treated with two 15mug or 30mug 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 15mug 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 15mug HA dose, the seroprotective rates were 93.2% and 73.1%, respectively. The seroprotective rates for recipients of 30mug 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 30mug HA antigen. No vaccine-related serious adverse events occurred. The data indicated a single 15mug 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.
PMID: 20817013 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20817013