tetano
Editor, Senior Moderator
Vaccine
Available online 13 March 2013
In Press, Uncorrected Proof ? Note to users
Cover image
Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18?64 years of age
Geoffrey J. Gorsea, Corresponding author contact information, E-mail the corresponding author,
Ann R. Falseyb, E-mail the corresponding author,
John A. Flingc, E-mail the corresponding author,
Terry L. Polingd, E-mail the corresponding author,
Cynthia B. Stroute, E-mail the corresponding author,
Peter H. Tsangf, E-mail the corresponding author
a Saint Louis University School of Medicine, 1100 South Grand Blvd. (DRC-8th floor), St. Louis, MO 63104, USA
b Infectious Disease Unit, Rochester General Hospital, University of Rochester School of Medicine, 1425 Portland Ave., Rochester, NY 14621, USA
c University of North Texas Health Sciences Center, 855 Montgomery Street, Fort Worth, TX 76105, USA
d Heartland Research Associates, 1709 South Rock Road, Wichita, KS 67207, USA
e Coastal Carolina Research Center, 1156 Bowman Road, Suite 102, Mount Pleasant, SC, USA
f Clinical Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA
http://dx.doi.org/10.1016/j.vaccine.2013.03.008
Highlights
?
We compared reduced dose intradermal (ID) to standard dose intramuscular (IM) influenza vaccine.
?
Three lots of ID vaccine were comparable to each other.
?
The immunogenicity of the two vaccines was comparable.
?
Injection site reactions were more frequent with the ID vaccine except pain.
?
Systemic reactions were comparable except for more myalgia with IM vaccine.
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 0.1 mL administered ID with a 30 gauge, 1.5 mm long needle were compared to standard dose vaccine (0.5 mL 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.
http://www.sciencedirect.com/science/article/pii/S0264410X13002673
Available online 13 March 2013
In Press, Uncorrected Proof ? Note to users
Cover image
Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18?64 years of age
Geoffrey J. Gorsea, Corresponding author contact information, E-mail the corresponding author,
Ann R. Falseyb, E-mail the corresponding author,
John A. Flingc, E-mail the corresponding author,
Terry L. Polingd, E-mail the corresponding author,
Cynthia B. Stroute, E-mail the corresponding author,
Peter H. Tsangf, E-mail the corresponding author
a Saint Louis University School of Medicine, 1100 South Grand Blvd. (DRC-8th floor), St. Louis, MO 63104, USA
b Infectious Disease Unit, Rochester General Hospital, University of Rochester School of Medicine, 1425 Portland Ave., Rochester, NY 14621, USA
c University of North Texas Health Sciences Center, 855 Montgomery Street, Fort Worth, TX 76105, USA
d Heartland Research Associates, 1709 South Rock Road, Wichita, KS 67207, USA
e Coastal Carolina Research Center, 1156 Bowman Road, Suite 102, Mount Pleasant, SC, USA
f Clinical Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370, USA
http://dx.doi.org/10.1016/j.vaccine.2013.03.008
Highlights
?
We compared reduced dose intradermal (ID) to standard dose intramuscular (IM) influenza vaccine.
?
Three lots of ID vaccine were comparable to each other.
?
The immunogenicity of the two vaccines was comparable.
?
Injection site reactions were more frequent with the ID vaccine except pain.
?
Systemic reactions were comparable except for more myalgia with IM vaccine.
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 0.1 mL administered ID with a 30 gauge, 1.5 mm long needle were compared to standard dose vaccine (0.5 mL 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.
http://www.sciencedirect.com/science/article/pii/S0264410X13002673