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A Phase 1 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of a Nipah Vaccine, HeV-sG-V (Hendra Virus Soluble Glycoprotein Vaccine), in Healthy Adults

A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.

开始日期2020-02-18

申办/合作机构

Auro Vaccines LLC初创企业

[+3]

NCT02718469 / Completed临床1期

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Monovalent Ebola Zaire Vaccine (rVSVN4CT1-EBOVGP1) Delivered by Intramuscular Injection in Healthy Adult Subjects

The purpose of this study is to assess the safety profile of the Zaire Ebola vaccine and the strength of the immune response.

开始日期2015-12-22

申办/合作机构

Auro Vaccines LLC初创企业

[+2]

NCT02756208 / Completed临床1期IIT

A Phase I Safety and Immunogenicity Trial of IHV01 in HIV-1 Uninfected Volunteers

This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).

开始日期2015-11-01

申办/合作机构

University of Maryland Baltimore

[+2]

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0 项与 Auro Vaccines LLC 相关的专利（医药）

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2

项与 Auro Vaccines LLC 相关的文献（医药）

ACS Applied Bio Materials

Nano-Assembled Polyphosphazene Delivery System Enables Effective Intranasal Immunization with Nipah Virus Subunit Vaccine

作者: Hlushko, Raman ; Lazaro, Glorie G. ; Yunus, Abdul S. ; Dimitrov, Antony S. ; Andrianov, Alexander K. ; Promeneur, Dominique ; Marin, Alexander ; Broder, Christopher C. ; Leyva-Grado, Victor H. ; Hamm, Stefan ; Luckay, Amara

The ultimate vaccine against infections caused by Nipah virus should be capable of providing protection at the respiratory tract-the most probable port of entry for this pathogen.Intranasally delivered vaccines, which target nasal-associated lymphoid tissue and induce both systemic and mucosal immunity, are attractive candidates for enabling effective vaccination against this lethal disease.Herein, the water-soluble polyphosphazene delivery vehicle assembles into nanoscale supramol. constructs with the soluble extracellular portion of the Hendra virus attachment glycoprotein-a promising subunit vaccine antigen against both Nipah and Hendra viruses.These supramol. constructs signal through Toll-like receptor 7/8 and promote binding interactions with mucin-an important feature of effective mucosal adjuvants.High mass contrast of phosphorus-nitrogen backbone of the polymer enables a successful visualization of nanoconstructs in their vitrified state by cryogenic electron microscopy.Here, we characterize the self-assembly of polyphosphazene macromol. with biol. relevant ligands by asym. flow field flow fractionation, dynamic light scattering, fluorescence spectrophotometry, and turbidimetric titration methods.Furthermore, a polyphosphazene-enabled intranasal Nipah vaccine candidate demonstrates the ability to induce immune responses in hamsters and shows superiority in inducing total IgG and neutralizing antibodies when benchmarked against the resp. clin. stage alum adjuvanted vaccine.The results highlight the potential of polyphosphazene-enabled nanoassemblies in the development of intranasal vaccines.

JCI Insight

Focusing HIV-1 Gag T-cell Responses to Highly Conserved Regions by DNA Vaccination in HVTN 119

Article

作者: DeCamp, Allan C ; Hu, Jiani ; McElrath, M Juliana ; Pavlakis, George N ; Bear, Jenifer ; Hannaman, Drew ; De Rosa, Stephen C ; Pensiero, Michael N ; Allen, Mary A ; Felber, Barbara K ; Rosati, Margherita ; Tomaras, Georgia D ; Kalams, Spyros A ; Heptinstall, Jack ; Egan, Michael A ; Eldridge, John ; Mullins, James I ; Scott, Hyman M

BACKGROUNDAn HIV-1 DNA vaccine composed of 7 highly conserved, structurally important elements (conserved elements, CE) of p24Gag was tested in a phase I randomized, double-blind clinical trial (HVTN 119, NCT03181789) in people without HIV. DNA vaccination of CE prime/CE+p55Gag boost was compared with p55Gag.METHODSTwo groups (n = 25) received 4 DNA vaccinations (CE/CE+p55Gag or p55Gag) by intramuscular injection/electroporation, including IL-12 DNA adjuvant. The placebo group (n = 6) received saline. Participants were followed for safety and tolerability. Immunogenicity was assessed for T cell and antibody responses.RESULTSBoth regimens were safe and generally well tolerated. The p24CE vaccine was immunogenic and significantly boosted by CE+p55Gag (64% CD4+, P = 0.037; 42% CD8+, P = 0.004). CE+p55Gag induced responses to 5 of 7 CE, compared with only 2 CE by p55Gag DNA, with a higher response to CE5 in 30% of individuals (P = 0.006). CE+p55Gag induced significantly higher CD4+ CE T cell breadth (0.68 vs. 0.22 CE; P = 0.029) and a strong trend for overall T cell breadth (1.14 vs. 0.52 CE; P = 0.051). Both groups developed high cellular and humoral responses. p24CE vaccine-induced CD4+ CE T cell responses correlated (P = 0.007) with p24Gag antibody responses.CONCLUSIONThe CE/CE+p55Gag DNA vaccine induced T cell responses to conserved regions in p24Gag, increasing breadth and epitope recognition throughout p55Gag compared with p55Gag DNA. Vaccines focusing immune responses by priming responses to highly conserved regions could be part of a comprehensive HIV vaccine strategy.TRIAL REGISTRATIONClinical Trials.gov NCT03181789FUNDINGHVTN, NIAID/NIH.

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