Aeras Global Tb Vaccine Foundation

US Government As Represented by the Secretary of the Army

Crucell Holland B.v.

Beth Israel Deaconess Medical Center, Inc.

Janssen Pharmaceuticals, Inc.

Janssen Vaccines & Prevention B.v.

Leland Stanford Junior University

Merck + Co., Inc.

Solvay Sa

Aeras Global Tuberculosis Vaccine Foundation

Jerald C Sadoff

David M Hone

Alan S Cross

Ronggai Sun

Apurba K Bhattacharjee

Mohamad Fakruddin Jamiluddin

Wendell David Zollinger

John Fulkerson

Donata R Sizemore

Ravi P Anantha

John F Fulkerson, Jr

Ronald Vogels

Katarina Radosevic

Arthur A Branstrom

Anat Zvi

Avigdor Shafferman

Dan H Barouch

Johannes Petrus Maria Langedijk

Menzo Jans Emco Havenga

Lucy Rutten

Frank Wegmann

David Adrianus Theodorus Maria Zuijdgeest

An Vandebosch

Rosemary Chang

Mathieu Claude Michel Le Gars

Olivier Godeaux

Mark Johannes Gerardus Bakkers

Yasir Abdul Wahid Skeiky

Naomi Ariel

Rinke Bos

Thomas R Tice

Yasir A W Skeiky

Gerald B Pier

Gary K Schoolnik

Jean A Setterstrom

John E Van Hamont

Mark William Bodmer

Robert H Reid

F Donald Roberts

Benoit Christophe Stephan Callendret

Menzo J E Havenga

Myra Noorely Widjojoatmodjo

Charles E McQueen

Elliot Jacob

Phil Friden

Macaya Julie Douoguih

David Onyabe

Peter A Castric

Michele Stone

Mario Alberto Flores-Valdez

Michel Klein

Anisah Alyahya

Edgar C Boedecker

Ramassubbu Jeyanthi

Jason C Grove

Steven Michael Opal

Kristi Lynn Williams

Christina Y Chan

Roaggai Sun

David Michael Hone

Yasir Abdul Skeiky

Menzo Jans Havenga

The invention relates to immunogenic compositions and vaccines containing a coronavirus (e.g., Wuhan coronavirus (2019-nCoV; also referred to as SARS-CoV-2)) protein or a polynucleotide encoding a coronavirus (e.g., Wuhan coronavirus (2019-nCoV; SARS-CoV-2)) protein and uses thereof. The invention also provides methods of treating and/or preventing a coronavirus (e.g., Wuhan coronavirus (2019-nCoV; SARS-CoV-2)) infection by administering an immunogenic composition or vaccine to a subject (e.g., a human). The invention also provides methods of detecting and/or monitoring a protective anti-coronavirus (e.g., Wuhan coronavirus (2019-nCoV; SARS-CoV-2)) antibody response (e.g., anti-coronavirus antibody response, e.g., anti-2019-nCoV antibody response, e.g., anti-Spike antibody response, e.g., anti-Spike neutralizing antibody response). The present invention relates to isolated nucleic and/or recombinant nucleic acid encoding a coronavirus S protein, in particular a SARS-CoV-2 S protein, and to the coronavirus S proteins, as well as to the use of the nucleic acids and/or proteins thereof in vaccines.

Compositions and methods for preventing and treating coronavirus infection&#x2014;SARS-CoV-2 vaccines

Methods of inducing a safe immune response against respiratory syncytial virus (RSV) in a human subject in need thereof, including administering to the subject a composition including recombinant adenovirus including a nucleic acid encoding an RSV Fusion (F) protein including the amino acid sequence of SEQ ID NO: 1, and a pharmaceutically acceptable carrier, in a total dose of from about 1&#xd7;10to about 2&#xd7;10viral particles (vp), are described.

Method for the safe induction of immunity against RSV

Compositions, vaccines and methods using adenovirus vectors for inducing protective immunity against a respiratory syncytial virus (RSV) infection are described.

Methods and compositions for inducing protective immunity against RSV infection

The invention provides a method for therapeutic treatment of a patient having active tuberculosis (TB), the method comprising: administering to the patient a recombinant adenovirus vector that comprises nucleic acid encoding the Ag85A, Ag85B and TB10.4 antigens of(Mtb). Advantageously, the method can be used to shorten conventional drug therapy for treating active TB.

Therapeutic vaccination against active Tuberculosis

Malaria vaccines based on polyepitope constructs that elicit cell-mediated immunity against a broad spectrum of malaria parasites and which cover the majority of HLA alleles are provided. Epitopes in the polyepitope constructs are from regions of thecircumsporozoite protein (CSP) known to contain CD4 and CD8 T cell epitopes, and include both epitopes from highly variable and highly conserved regions of CSP.

Malaria vaccine compositions and constituents which elicit cell mediated immunity

Bacterial delivery systems with improved transgene expression are provided. The recombinant bacterial delivery systems deliver transgenes of interest and suppressors of the eukaryotic Type I interferon response to eukaryotic cells. Suppression of the eukaryotic Type I interferon response allows improved expression of the encoded transgene.

Methods to increase transgene expression from bacterial-based delivery systems by co-expressing suppressors of the eukaryotic type I interferon response

The invention relates to vaccines comprising recombinant vectors, such as recombinant adenoviruses. The vectors comprise heterologous nucleic acids encoding for at least two antigens from one or more tuberculosis-causing bacilli. Also described is the use of specific protease recognition sites linking antigens through which the encoded antigens are separated upon cleavage. After cleavage, the antigens contribute to the immune response in a separate manner. The recombinant vectors may comprise a nucleic acid encoding the protease cleaving the linkers and separating the antigens. Further described is the use of genetic adjuvants encoded by the recombinant vectors, wherein such genetic adjuvants may also be cleaved through the presence of the cleavable linkers and the specific protease.

Multivalent vaccines comprising recombinant viral vectors

A vaccine against(Mtb) is provided. The vaccine comprises a recombinant Bacille Calmette-Guerin (BCG) subunit-based vaccine in which one or more Mtb antigens and one or more Mtb resuscitation or reactivation antigens are overexpressed, and in which at least a portion of the DosR regulon is up-regulated. The vaccine is protective against active Mtb infection both pre- and post-exposure to Mtb, and thus prevents disease symptoms due to the recurrence of a latent Mtb infection.

Recombinant BCG tuberculosis vaccine designed to elicit immune responses to mycobacterium tuberculosis in all physiological stages of infection and disease

Described are vaccines comprising recombinant vectors, such as recombinant adenoviruses. The vectors comprise heterologous nucleic acids encoding at least two antigens from one or more tuberculosis-causing bacilli. Also described is the use of specific protease recognition sites linking antigens through which the encoded antigens are separated upon cleavage. After cleavage, the antigens contribute to the immune response in a separate manner. The recombinant vectors may comprise a nucleic acid encoding the protease cleaving the linkers and separating the antigens. Also described is the use of genetic adjuvants encoded by the recombinant vectors, wherein such genetic adjuvants may also be cleaved through the presence of the cleavable linkers and the specific protease.

Bacterial packaging strains useful for generating recombinant double-stranded RNA nucleocapsids (rdsRNs) are provided. The packaging strains are useful for the production of RNA encoding vaccine antigens, bioactive proteins, immunoregulatory proteins, antisense RNAs, and catalytic RNAs in eukaryotic cells or tissues. Recombinant ssRNA is introduced into the strains and packaged to form rdsRNs de novo.

Bacterial packaging strains useful for generation and production of recombinant double-stranded RNA nucleocapsids and uses thereof

strains that have an enhanced ability to elicit a MHC-Class I-restricted CD8T cell immune response are provided. Thestrains are genetically engineered to express: a endosomalytic protein that is active at neutral pH (e.g. Perfringolysin O), permitting escape of thefrom endosomes into the cytoplasm of the cell; and antigens of interest, such as tuberculosis antigens. The invention also provides vaccine preparations containing suchstrains.

Recombinant BCG strains with enhanced ability to escape the endosome

The invention relates to vaccines comprising recombinant vectors, such as recombinant adenoviruses. The vectors comprise heterologous nucleic acids encoding for at least two antigens from one or more tuberculosis-causing bacilli. The invention also relates to the use of specific protease recognition sites linking antigens through which the encoded antigens are separated upon cleavage. After cleavage, the antigens contribute to the immune response in a separate manner. The recombinant vectors may comprise a nucleic acid encoding the protease cleaving the linkers and separating the antigens. The invention furthermore relates to the use of genetic adjuvants encoded by the recombinant vectors, wherein such genetic adjuvants may also be cleaved through the presence of the cleavable linkers and the specific protease.

A vaccine for treating or preventing the establishment of latent tuberculosis infections is provided. The vaccine comprises a recombinantthat overexpresses the transcription factor DosR, at a level sufficient to induce production of the dosR regulon genes or proteins. A host to whom the vaccine is administered mounts an immune response to the dosR regulon proteins and is thus protected from the establishment, persistence or reactivation of latent tuberculosis.

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Washington, DC, United States of America

Jerald C Sadoff