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A reduced-dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients in a randomized controlled trial.
Clin Vaccine Immunol. 2012 Mar; 19(3):313-8.CV

Abstract

With the recent pandemic of influenza A (H1N1) and vaccine shortages, there has been considerable interest in developing influenza vaccines with reduced doses, allowing for increased production capacity. Here we report a prospective, randomized, double-blind, single-center clinical trial of a reduced-dose whole-virion inactivated, adjuvanted influenza vaccine in adult and elderly volunteers. A total of 234 subjects, including 120 adults (18 to 60 years of age) and 114 elderly subjects (>60 years of age) were enrolled to receive either 6 μg or the conventional 15-μg dose of seasonal trivalent influenza vaccines. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition testing. The subjects developed antibody responses against the seasonal influenza A virus H1N1 and H3N2 strains, as well as the seasonal influenza B virus included in the vaccines. Single doses of 6 μg fulfilled licensing criteria for seasonal influenza vaccines. No significant differences in rates of seroconversion or seroprotection or in geometric mean titers were found between the two dosage levels. All adverse events were rare, mild, and transient. We found that the present reduced-dose vaccine is safe and immunogenic in healthy adult and elderly subjects and triggers immune responses that comply with licensing criteria.

Authors+Show Affiliations

University of Debrecen, Medical and Health Sciences Center, Debrecen, Hungary. zoltanvajo@gmail.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22219315

Citation

Vajo, Zoltan, et al. "A Reduced-dose Seasonal Trivalent Influenza Vaccine Is Safe and Immunogenic in Adult and Elderly Patients in a Randomized Controlled Trial." Clinical and Vaccine Immunology : CVI, vol. 19, no. 3, 2012, pp. 313-8.
Vajo Z, Tamas F, Jankovics I. A reduced-dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients in a randomized controlled trial. Clin Vaccine Immunol. 2012;19(3):313-8.
Vajo, Z., Tamas, F., & Jankovics, I. (2012). A reduced-dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients in a randomized controlled trial. Clinical and Vaccine Immunology : CVI, 19(3), 313-8. https://doi.org/10.1128/CVI.05619-11
Vajo Z, Tamas F, Jankovics I. A Reduced-dose Seasonal Trivalent Influenza Vaccine Is Safe and Immunogenic in Adult and Elderly Patients in a Randomized Controlled Trial. Clin Vaccine Immunol. 2012;19(3):313-8. PubMed PMID: 22219315.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A reduced-dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients in a randomized controlled trial. AU - Vajo,Zoltan, AU - Tamas,Ferenc, AU - Jankovics,Istvan, Y1 - 2012/01/04/ PY - 2012/1/6/entrez PY - 2012/1/6/pubmed PY - 2012/6/14/medline SP - 313 EP - 8 JF - Clinical and vaccine immunology : CVI JO - Clin Vaccine Immunol VL - 19 IS - 3 N2 - With the recent pandemic of influenza A (H1N1) and vaccine shortages, there has been considerable interest in developing influenza vaccines with reduced doses, allowing for increased production capacity. Here we report a prospective, randomized, double-blind, single-center clinical trial of a reduced-dose whole-virion inactivated, adjuvanted influenza vaccine in adult and elderly volunteers. A total of 234 subjects, including 120 adults (18 to 60 years of age) and 114 elderly subjects (>60 years of age) were enrolled to receive either 6 μg or the conventional 15-μg dose of seasonal trivalent influenza vaccines. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition testing. The subjects developed antibody responses against the seasonal influenza A virus H1N1 and H3N2 strains, as well as the seasonal influenza B virus included in the vaccines. Single doses of 6 μg fulfilled licensing criteria for seasonal influenza vaccines. No significant differences in rates of seroconversion or seroprotection or in geometric mean titers were found between the two dosage levels. All adverse events were rare, mild, and transient. We found that the present reduced-dose vaccine is safe and immunogenic in healthy adult and elderly subjects and triggers immune responses that comply with licensing criteria. SN - 1556-679X UR - https://www.unboundmedicine.com/medline/citation/22219315/A_reduced_dose_seasonal_trivalent_influenza_vaccine_is_safe_and_immunogenic_in_adult_and_elderly_patients_in_a_randomized_controlled_trial_ L2 - https://journals.asm.org/doi/10.1128/CVI.05619-11?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -