tetano
Editor, Senior Moderator
Vaccine. 2013 Oct 30. pii: S0264-410X(13)01454-0. doi: 10.1016/j.vaccine.2013.10.061. [Epub ahead of print]
Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1.
M?ssler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T.
Source
AVIR Green Hills Biotechnology, 1200 Vienna, Austria. Electronic address: christina_moessler@baxter.com.
Abstract
BACKGROUND:
The non-structural protein NS1 of the influenza virus counteracts the interferon-mediated immune response of the host. We investigated the safety and immunogenicity of a trivalent formulation containing influenza H1N1, H3N2 and B strains lacking NS1 (delNS1-trivalent).
METHODS:
Healthy adult study participants who were seronegative for at least one strain present in the vaccine formulation were randomized to receive a single intranasal dose of delNS1-trivalent vaccine at 7.0log10 TCID50/subject (n=39) or placebo (n=41).
RESULTS:
Intranasal vaccination with the live replication-deficient delNS1-trivalent vaccine was well tolerated with no treatment-related serious adverse events. The most common adverse events identified, i.e. headache, oropharyngeal pain and rhinitis-like symptoms, were mainly mild and transient and distributed similarly in the treatment and placebo groups. Significant vaccine-specific immune responses were induced. Pre-existing low antibody titers or seronegativity for the corresponding vaccine strain yielded better response rates.
CONCLUSIONS:
We show that vaccination with a replication-deficient trivalent influenza vaccine containing H1N1, H3N2 and B strains lacking NS1 is safe and induces significant levels of antibodies (ClinicalTrials.gov identifier NCT01369862).
Copyright ? 2013. Published by Elsevier Ltd.
KEYWORDS:
Influenza, Intranasal, Live-attenuated, NS1, Reverse genetics, Trivalent
PMID:
24183981
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24183981
Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1.
M?ssler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T.
Source
AVIR Green Hills Biotechnology, 1200 Vienna, Austria. Electronic address: christina_moessler@baxter.com.
Abstract
BACKGROUND:
The non-structural protein NS1 of the influenza virus counteracts the interferon-mediated immune response of the host. We investigated the safety and immunogenicity of a trivalent formulation containing influenza H1N1, H3N2 and B strains lacking NS1 (delNS1-trivalent).
METHODS:
Healthy adult study participants who were seronegative for at least one strain present in the vaccine formulation were randomized to receive a single intranasal dose of delNS1-trivalent vaccine at 7.0log10 TCID50/subject (n=39) or placebo (n=41).
RESULTS:
Intranasal vaccination with the live replication-deficient delNS1-trivalent vaccine was well tolerated with no treatment-related serious adverse events. The most common adverse events identified, i.e. headache, oropharyngeal pain and rhinitis-like symptoms, were mainly mild and transient and distributed similarly in the treatment and placebo groups. Significant vaccine-specific immune responses were induced. Pre-existing low antibody titers or seronegativity for the corresponding vaccine strain yielded better response rates.
CONCLUSIONS:
We show that vaccination with a replication-deficient trivalent influenza vaccine containing H1N1, H3N2 and B strains lacking NS1 is safe and induces significant levels of antibodies (ClinicalTrials.gov identifier NCT01369862).
Copyright ? 2013. Published by Elsevier Ltd.
KEYWORDS:
Influenza, Intranasal, Live-attenuated, NS1, Reverse genetics, Trivalent
PMID:
24183981
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24183981