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Co-administration of seasonal influenza vaccine and an adenovirus based respiratory syncytial virus vaccine

A technology of influenza virus, syncytial virus, applied in medical field

Pending Publication Date: 2022-01-11
JANSSEN VACCINES & PREVENTION BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the spectrum of illness caused by influenza B viruses is generally milder than that caused by influenza A viruses, severe illness requiring hospitalization is still frequently observed with influenza B viruses

Method used

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  • Co-administration of seasonal influenza vaccine and an adenovirus based respiratory syncytial virus vaccine
  • Co-administration of seasonal influenza vaccine and an adenovirus based respiratory syncytial virus vaccine
  • Co-administration of seasonal influenza vaccine and an adenovirus based respiratory syncytial virus vaccine

Examples

Experimental program
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preparation example Construction

[0079] RAd26 vector preparation are described in e.g. WO 2007 / 104792 and Abbink et al., Virol [Virology] .2007: 81 (9): 4654-63 in. An exemplary genomic sequence Ad26 are found in GenBank Accession No. EF 153474 and WO 2007 / 104792 of SEQ ID NO: l are. RAd35 vector preparation are described in, for example, U.S. Pat. No. 7,270,811, WO00 / 70071 and Vogels et al, J Virol [Journal of Virology] .2003: 77 (15): 8263-71 in. An exemplary genomic sequence of the gene found Ad35 registered in GenBank No. AC 000019 and WO 00 / 70071 of Image 6 middle.

[0080] Recombinant adenovirus according to the invention may be replication competent or replication defective. In certain embodiments, the adenovirus is a replication-defective, e.g., because it contains a deletion in the El region of the genome. As known to those skilled, in the absence of essential regions from the adenovirus genome, these regions encoded functions must preferably is a producer cell in trans, i.e., as part of El, E2 and / o...

example 1

[0112] Example 1: 2A Human Studies

[0113] A 2A phase, random allocation, double blind, placebo-controlled studies were carried out to assess seasonal flu vaccines and ad26.rsv.pref in healthy adults of 60, and above (AD26 without replication). DNA transgenes encoding the fusion conformation of the RSV A2 strain fusion conformations in the case of common administration and non-joint administration.

[0114] Research Design / Overview -

[0115] A single center, random allocation, placebo control, double-blind 2A study was conducted in a male and female subject of approximately 180 ages and stable health conditions. These subjects were 1: 1 The ratio is randomly assigned to a group of two groups:

[0116] - Group 1 ("COAD")) Accept 1X10 on the first day 11 AD26.RSV.PREF of a viral particles (VP), is administered simultaneously with commercially available seasonal influenza vaccines and is accommodated on day 29.

[0117] - Group 2 (control) received placebo on day 1, administered...

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Abstract

Methods of inducing a protective immune response against respiratory syncytial virus (RSV) and against influenza virus, without inducing a severe adverse event in human subjects are described. The methods include administering to the subjects an effective amount of an adenoviral vector encoding a recombinant RSV F polypeptide that is stabilized in a prefusion conformation, along with an effective amount of an influenza vaccine.

Description

Technical field [0001] The present invention is in the field of medicine. In particular, embodiments of the present invention relates to a vaccine and a vaccine composition, and adenovirus-based influenza and for prophylactic treatment of respiratory syncytial virus (RSV) influenza virus infection. Background technique [0002] Respiratory syncytial virus (RSV) is considered the most important reason (Hall et al infants and children under 5 years of severe acute respiratory disease, N Engl J Med [New England Journal of Medicine] .2009: 360; 588-598; Shay et al., JAMA [Journal of the American Medical Association] .1999: 282; 1440-1446; Stockman et al., Pediatr Infect Dis J [Journal of pediatrics infectious diseases] .2012: 31; 5-9). Worldwide, each year an estimated 3.4 million people hospitalized due to RSV. In the United States, RSV infection results in children under age 5 have 57,000 to 175,000 hospitalizations each year, 500,000 emergency department, and about 500 people were...

Claims

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Application Information

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IPC IPC(8): A61K39/12A61P31/14A61P31/16
CPCA61K2039/70C12N2760/16134C12N2760/16234A61K39/12C12N2710/10343C12N2760/18534A61P31/14A61P31/16A61K39/155A61K39/145A61K2039/54A61K2300/00A61K2039/5256A61K2039/545C12N7/00C12N15/86C12N2750/00023C12N2750/00043C12N2760/16034C12N2760/16071C12N2760/18571
Inventor B·C·S·卡朗德雷J·C·萨多夫E·德帕普
Owner JANSSEN VACCINES & PREVENTION BV