tetano
Editor, Senior Moderator
Vaccine. 2013 Mar 11. pii: S0264-410X(13)00267-3. doi: 10.1016/j.vaccine.2013.03.008. [Epub ahead of print]
Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age.
Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH.
Source
Saint Louis University School of Medicine, 1100 South Grand Blvd. (DRC-8th floor), St. Louis, MO 63104, USA. Electronic address: gorsegj@slu.edu.
Abstract
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?g hemagglutinin (HA) per strain in 0.1mL administered ID with a 30 gauge, 1.5mm long needle were compared to standard dose vaccine (0.5mL containing 15?g 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.
Copyright ? 2013. Published by Elsevier Ltd.
PMID:
23499604
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23499604
Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age.
Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH.
Source
Saint Louis University School of Medicine, 1100 South Grand Blvd. (DRC-8th floor), St. Louis, MO 63104, USA. Electronic address: gorsegj@slu.edu.
Abstract
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?g hemagglutinin (HA) per strain in 0.1mL administered ID with a 30 gauge, 1.5mm long needle were compared to standard dose vaccine (0.5mL containing 15?g 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.
Copyright ? 2013. Published by Elsevier Ltd.
PMID:
23499604
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23499604