Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age
| Autor: | Cynthia Strout, Peter H. Tsang, Geoffrey J. Gorse, John A. Fling, Ann R. Falsey, Terry L. Poling |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Trivalent influenza vaccine
Adult Male Adolescent Injections Intradermal Influenza vaccine Pain medicine.disease_cause Antibodies Viral Injections Intramuscular Young Adult Influenza A Virus H1N1 Subtype Double-Blind Method Influenza Human Influenza A virus medicine Live attenuated influenza vaccine Humans Seroconversion Duck embryo vaccine General Veterinary General Immunology and Microbiology business.industry Influenza A Virus H3N2 Subtype Vaccination Public Health Environmental and Occupational Health Hemagglutination Inhibition Tests Middle Aged Virology Titer Influenza B virus Infectious Diseases Influenza Vaccines Immunology Antibody Formation Molecular Medicine Female business |
| Zdroj: | Vaccine. 31(19) |
| ISSN: | 1873-2518 |
| Popis: | Background To increase vaccine acceptance, intradermal (ID) influenza vaccine (Fluzone ® Intradermal, Sanofi Pasteur Inc.) may be an attractive alternative to intramuscular (IM) vaccination due to smaller needle and volume injected. Methods A multicenter, randomized (2:1 ID vs IM vaccines) study, blinded for ID vaccine lots, was conducted among 4292 adults 18–64 years of age enrolled in October 2008. Three lots of investigational trivalent influenza vaccine containing 9 μg hemagglutinin (HA) per strain in 0.1 mL administered ID with a 30 gauge, 1.5 mm long needle were compared to standard dose vaccine (0.5 mL containing 15 μg HA/strain) given IM. Results The post-vaccination antibody geometric mean titers (GMT) for the ID vaccine were similar to the IM vaccine (H1N1: 193.2 vs. 178.3, H3N2: 246.7 vs. 230.7, and B: 102.5 vs. 126.9). Non-inferiority was met for the ID vaccine compared to IM vaccine as assessed by antibody GMT ratios (IM/ID) for all three virus strains (H1N1: 0.92, H3N2: 0.94, and B: 1.24). Seroconversion rates were non-inferior for H1N1 and H3N2, but not for B (ID vs. IM: H1N1: 61.2% vs. 60.5%, H3N2: 75.3% vs. 74.8%, and B: 46.2% vs. 54.2%). Seroprotection (HAI titer ≥1:40) rates were similar between groups (ID vs. IM, H1N1: 91.1% vs. 91.7%, H3N2: 90.7% vs. 91.4%, and B: 87.4% vs. 89.3%). Local injection site reactions overall were more common with ID than IM vaccine (ID vs. IM: 89.2% vs. 60.2%), but were usually grade 1 or 2 and transient. The frequencies of local injection site pain and systemic reactions were similar between vaccine groups, except more myalgia with IM vaccine. Conclusions The ID vaccine elicited immune responses comparable to IM vaccine except for the seroconversion rate to B virus. With the exception of pain, local injection site reactions were more common with the ID vaccine, but well-tolerated and of short duration. Trial registration ClinicalTrials.gov identifier: NCT00772109 . |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect