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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.
Vaccine. 2010 Oct 21; 28(45):7337-43.V

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 15 μg hemagglutination (HA) antigen dose, two 15 μg or 30 μg HA doses in 3 weeks apart, and the 107 elders were treated with two 15 μg or 30 μg 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 15 μg 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 15 μg HA dose, the seroprotective rates were 93.2% and 73.1%, respectively. The seroprotective rates for recipients of 30 μg 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 30 μg HA antigen. No vaccine-related serious adverse events occurred. The data indicated a single 15 μg 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.

Authors+Show Affiliations

Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20817013

Citation

Kung, Hsiang-Chi, et al. "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." Vaccine, vol. 28, no. 45, 2010, pp. 7337-43.
Kung HC, Huang KC, Kao TM, et al. 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. Vaccine. 2010;28(45):7337-43.
Kung, H. C., Huang, K. C., 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., Huang, L. M., & Hsieh, S. M. (2010). 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. Vaccine, 28(45), 7337-43. https://doi.org/10.1016/j.vaccine.2010.08.073
Kung HC, et al. 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. Vaccine. 2010 Oct 21;28(45):7337-43. PubMed PMID: 20817013.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kung,Hsiang-Chi, AU - Huang,Kuo-Chin, AU - Kao,Tsui-Mai, AU - Lee,Yi-Chien, AU - Chang,Feng-Yee, AU - Wang,Ning-Chi, AU - Liu,Yung-Ching, AU - Lee,Wen-Sen, AU - Liu,Hsing-Jin, AU - Chen,Chin-I, AU - Chen,Chien-Hui, AU - Huang,Li-Min, AU - Hsieh,Szu-Min, Y1 - 2010/09/17/ PY - 2010/03/10/received PY - 2010/07/25/revised PY - 2010/08/16/accepted PY - 2010/9/7/entrez PY - 2010/9/8/pubmed PY - 2011/1/25/medline SP - 7337 EP - 43 JF - Vaccine JO - Vaccine VL - 28 IS - 45 N2 - 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 15 μg hemagglutination (HA) antigen dose, two 15 μg or 30 μg HA doses in 3 weeks apart, and the 107 elders were treated with two 15 μg or 30 μg 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 15 μg 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 15 μg HA dose, the seroprotective rates were 93.2% and 73.1%, respectively. The seroprotective rates for recipients of 30 μg 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 30 μg HA antigen. No vaccine-related serious adverse events occurred. The data indicated a single 15 μg 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)01243-0 DB - PRIME DP - Unbound Medicine ER -