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Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age.
Vaccine. 2013 May 01; 31(19):2358-65.V

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 9μg 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 15μg 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.

Authors+Show Affiliations

Saint Louis University School of Medicine, 1100 South Grand Blvd. (DRC-8th floor), St. Louis, MO 63104, USA. gorsegj@slu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23499604

Citation

Gorse, Geoffrey J., et al. "Intradermally-administered Influenza Virus Vaccine Is Safe and Immunogenic in Healthy Adults 18-64 Years of Age." Vaccine, vol. 31, no. 19, 2013, pp. 2358-65.
Gorse GJ, Falsey AR, Fling JA, et al. Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine. 2013;31(19):2358-65.
Gorse, G. J., Falsey, A. R., Fling, J. A., Poling, T. L., Strout, C. B., & Tsang, P. H. (2013). Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine, 31(19), 2358-65. https://doi.org/10.1016/j.vaccine.2013.03.008
Gorse GJ, et al. Intradermally-administered Influenza Virus Vaccine Is Safe and Immunogenic in Healthy Adults 18-64 Years of Age. Vaccine. 2013 May 1;31(19):2358-65. PubMed PMID: 23499604.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. AU - Gorse,Geoffrey J, AU - Falsey,Ann R, AU - Fling,John A, AU - Poling,Terry L, AU - Strout,Cynthia B, AU - Tsang,Peter H, Y1 - 2013/03/13/ PY - 2012/11/30/received PY - 2013/02/12/revised PY - 2013/03/04/accepted PY - 2013/3/19/entrez PY - 2013/3/19/pubmed PY - 2014/2/11/medline SP - 2358 EP - 65 JF - Vaccine JO - Vaccine VL - 31 IS - 19 N2 - 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 9μg 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 15μg 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23499604/Intradermally_administered_influenza_virus_vaccine_is_safe_and_immunogenic_in_healthy_adults_18_64_years_of_age_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(13)00267-3 DB - PRIME DP - Unbound Medicine ER -