A Double Blind, Randomized, Placebo-Controlled, Phase I Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated West Nile Virus Vaccine, HydroVax-001, in Healthy Adults

This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 4 mcg.

Start Date31 Mar 2015

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Live attenuated viral vaccine(Najit Technologies, Inc.)

100 Translational Medicine associated with Live attenuated viral vaccine(Najit Technologies, Inc.)

100 Patents (Medical) associated with Live attenuated viral vaccine(Najit Technologies, Inc.)

Literatures (Medical) associated with Live attenuated viral vaccine(Najit Technologies, Inc.)

01 Sep 2024·Annals of Allergy, Asthma & Immunology

Is it safe and effective to give live viral vaccines to patients on biologics?

Article

Author: Tracy, James M ; Marshall, Gailen D

04 Jul 2023·Avian Pathology

The protection conferred against virulent Newcastle disease virus (vNDV) genotype VII by commercial double recombinant HVT vaccines and NDV live-attenuated vaccine as prime/boost vaccination regimens in commercial broiler chickens carrying maternally-derived antibodies (MDAs) against NDV

Article

Author: Hassanin, Ola ; Abdullatif, Tamer Mahmoud ; Ghanem, Ibrahim Abd Elrahman

Vaccines against vNDV are readily available and potentially protective; nevertheless, improved vaccination protocols are required to prevent clinical disease and discontinue the spread of the virus. This study assessed the effectiveness of two commercial recombinant herpesvirus of turkey vector vaccines (rHVT-NDV-IBDV) that express the fusion (F) protein of NDV and the virus protein 2 (VP2) of infectious bursal disease virus (IBDV). In commercial broilers with maternally-derived antibodies (MDAs) the efficacy of the rHVT-NDV-IBDV vaccines was evaluated when administered alone, in combination with live-attenuated NDV vaccine at one-day-old, or as part of a prime/boost strategy. The vaccinated birds were challenged with the genotype VIId vNDV strain (NDV/chicken/Egypt/1/2015) at various ages (14, 24 and 35 days). In comparison to sham-vaccinated control birds, the applied vaccination regimens were able to reduce or prevent mortality and virus shedding and clinical disease. Two weeks post-application, the two vector vaccines were serologically reactive with the MDAs and induced protective immune responses against the F protein. In the instance of early challenge at 14 days old, the combination of recombinant rHVT-NDV-IBDV with a live vaccine offered better protection and reduced virus shedding compared to the vector vaccine alone. Boosting with live NDV vaccine at 14 days old increased the protective effect of the vector vaccines and reduced virus shedding and the clinical index after challenge at 24 days old. Both combining and/or boosting with live vaccine together with the vector vaccine provided better protection and minimized virus shedding compared with vaccination with vector vaccine only in the instance of 5-week-old challenge.

01 May 2023·Veterinary Immunology and Immunopathology

Immune response following safer administration of recombinant Salmonella Typhimurium harboring ASFV antigens in pigs

Article

Author: Kim, Bumseok ; Chen, Baicheng ; Alam, Jahangir Md ; Jawalagatti, Vijay ; Kim, Jong-Hoon ; Bhilare, Kiran D. ; Lee, John-Hwa

African swine fever virus (ASFV) is a contagious epizootic pathogen adversely affecting porcine industry in Asian and European countries. Till date, 8 serotypes and 24 genotypes of the virus have been reported. Few live attenuated virus vaccine studies have reported to provide complete protection against ASFV infection but biohazard concern still remain. Recombinant subunit antigens are capable of providing cellular and humoral immunity in porcine, but not a single vaccine has hit the market yet. In the present study, we attempted to use recombinant Salmonella Typhimurium JOL912 strain harboring ASFV antigens (rSal-ASFV) to investigate its immunostimulant effect in porcine. Post intramuscular administration, we observed significant increment in the levels of helper T cells, cytotoxic T cells, natural killer (NK) cells, and immunoglobulin (i.e. IgG, IgA, and IgM) levels in rSal-ASFV treated groups. Further RT-PCR analysis indicated the increased expression of MHC-I, MHC-II, CD80/86, NK cell receptors (NKp30, NKp44, and NKp46) and cytokines while ELIspot analysis revealed significant production of IFN-γ in rSal-ASFV treated groups. Taken together, we are able to demonstrate that rSal-ASFV could elicit a non-specific cellular as well as humoral immune response. However, additional antigen specific immunity data is needed to evaluate its efficacy. Intramuscular administration of rSal-ASFV was found to be safe and immunostimulant in nature without any side-effects and may serve as an excellent option for in-vivo antigen delivery in pigs.

100 Deals associated with Live attenuated viral vaccine(Najit Technologies, Inc.)

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Indication	Highest Phase	Country/Location	Organization	Date
West Nile Fever	Phase 1	-	Washington University in St. Louis	-
West Nile Fever	Phase 1	-	Oregon Health & Science University	-
West Nile Fever	Phase 1	-	Najit Technologies, Inc.	-

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