lunes, 11 de mayo de 2015

Phase 1 study of pandemic h1 DNA vaccine in healthy adults. - PubMed - NCBI

Phase 1 study of pandemic h1 DNA vaccine in healthy adults. - PubMed - NCBI

 2015 Apr 17;10(4):e0123969. doi: 10.1371/journal.pone.0123969. eCollection 2015.

Phase 1 study of pandemic h1 DNA vaccine in healthy adults.

Abstract

BACKGROUND:

A novel, swine-origin influenza A (H1N1) virus was detected worldwide in April 2009, and the World Health Organization (WHO) declared a global pandemic that June. DNA vaccine priming improves responses to inactivated influenza vaccines. We describe the rapid production and clinical evaluation of a DNA vaccine encoding the hemagglutinin protein of the 2009 pandemic A/California/04/2009(H1N1) influenza virus, accomplished nearly two months faster than production of A/California/07/2009(H1N1) licensed monovalent inactivated vaccine (MIV).

METHODS:

20 subjects received three H1 DNA vaccinations (4 mg intramuscularly with Biojector) at 4-week intervals. Eighteen subjects received an optional boost when the licensed H1N1 MIV became available. The interval between the third H1 DNA injection and MIV boost was 3-17 weeks. Vaccine safety was assessed by clinical observation, laboratory parameters, and 7-day solicited reactogenicity. Antibody responses were assessed by ELISA, HAI and neutralization assays, and T cell responses by ELISpot and flow cytometry.

RESULTS:

Vaccinations were safe and well-tolerated. As evaluated by HAI, 6/20 developed positive responses at 4 weeks after third DNA injection and 13/18 at 4 weeks after MIV boost. Similar results were detected in neutralization assays. T cell responses were detected after DNA and MIV. The antibody responses were significantly amplified by the MIV boost, however, the boost did not increased T cell responses induced by DNA vaccine.

CONCLUSIONS:

H1 DNA vaccine was produced quickly, was well-tolerated, and had modest immunogenicity as a single agent. Other HA DNA prime-MIV boost regimens utilizing one DNA prime vaccination and longer boost intervals have shown significant immunogenicity. Rapid and large-scale production of HA DNA vaccines has the potential to contribute to an efficient response against future influenza pandemics.

TRIAL REGISTRATION:

Clinicaltrials.gov NCT00973895.

PMID:
 
25884189
 
[PubMed - in process] 
PMCID:
 
PMC4401709
 
Free PMC Article

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