A Phase I, Randomized, Observer-Blind Trial to Assess the Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA Vaccine Candidate Administered Intramuscularly and Intradermally by Jet Injection to Healthy Adults

The goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main question it aims to answer is:
• Is the VEE DNA Vaccine candidate safe
Participants will:
Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection
Provide blood and urine samples
Complete ECGs
Complete physical exams
Complete diaries

开始日期2023-10-16

申办/合作机构

PharmaJet, Inc.

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100 项与 Venezuelan Equine Encephalitis DNA Vaccine(PharmaJet) 相关的临床结果

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100 项与 Venezuelan Equine Encephalitis DNA Vaccine(PharmaJet) 相关的转化医学

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100 项与 Venezuelan Equine Encephalitis DNA Vaccine(PharmaJet) 相关的专利（医药）

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项与 Venezuelan Equine Encephalitis DNA Vaccine(PharmaJet) 相关的文献（医药）

2020-03-01·Journal of Virological Methods4区 · 医学

A new inactivation method to facilitate cryo-EM of enveloped, RNA viruses requiring high containment: A case study using Venezuelan Equine Encephalitis Virus (VEEV)

4区 · 医学

Article

作者: Vago, Frank ; Hasan, S Saif ; Williams, Evan P ; Lanman, Jason ; Parvate, Amar D ; Lee, Jasper ; Jonsson, Colleen B

The challenges associated with operating electron microscopes (EM) in biosafety level 3 and 4 containment facilities have slowed progress of cryo-EM studies of high consequence viruses. We address this gap in a case study of Venezuelan Equine Encephalitis Virus (VEEV) strain TC-83. Chemical inactivation of viruses may physically distort structure, and hence to verify retention of native structure, we selected VEEV strain TC-83 to develop this methodology as this virus has a 4.8 Å resolution cryo-EM structure. In our method, amplified VEEV TC-83 was concentrated directly from supernatant through a 30 % sucrose cushion, resuspended, and chemically inactivated with 1 % glutaraldehyde. A second 30 % sucrose cushion removed any excess glutaraldehyde that might interfere with single particle analyses. A cryo-EM map of fixed, inactivated VEEV was determined to a resolution of 7.9 Å. The map retained structural features of the native virus such as the icosahedral symmetry, and the organization of the capsid core and the trimeric spikes. Our results suggest that our strategy can easily be adapted for inactivation of other enveloped, RNA viruses requiring BSL-3 or BSL-4 for cryo-EM. However, the validation of inactivation requires the oversight of Biosafety Committee for each Institution.

2010-12-01·Vaccine3区 · 医学

Induction of neutralizing antibodies to Hendra and Nipah glycoproteins using a Venezuelan equine encephalitis virus in vivo expression system

3区 · 医学

Article

作者: Dimple Khetawat ; Gerald V. Quinnan ; Gabriel N. Defang ; Christopher C. Broder

The emergence of Hendra Virus (HeV) and Nipah Virus (NiV) which can cause fatal infections in both animals and humans has triggered a search for an effective vaccine. Here, we have explored the potential for generating an effective humoral immune response to these zoonotic pathogens using an alphavirus-based vaccine platform. Groups of mice were immunized with Venezuelan equine encephalitis virus replicon particles (VRPs) encoding the attachment or fusion glycoproteins of either HeV or NiV. We demonstrate the induction of highly potent cross-reactive neutralizing antibodies to both viruses using this approach. Preliminary study suggested early enhancement in the antibody response with use of a modified version of VRP. Overall, these data suggest that the use of an alphavirus-derived vaccine platform might serve as a viable approach for the development of an effective vaccine against the henipaviruses.

1979-12-01·Journal of Infectious Diseases2区 · 医学

Evaluation in Humans of a New, Inactivated Vaccine for Venezuelan Equine Encephalitis Virus (C-84)

2区 · 医学

Article

作者: Michael S. Ascher ; Helen H. Ramsburg ; Charles N. Oster ; Francis E. Cole ; Robert Edelman ; Gerald A. Eddy

A new, formalin-inactivated vaccine for Venezuelan equine encephalitis (VEE) virus (C-84), prepared from an attenuated vaccine strain of virus (TC-83), was tested in humans. Only occasional, mild, local and systemic reactions were noted in 28 volunteers; no meaningful changes in clinical laboratory values occurred. The vaccine augmented preexisting titers of serum neutralizing antibody to VEE virus in seropositive recipients of TC-83 vaccine, and it induced high titers of neutralizing antibody in nonimmune subjects after one primary and two booster vaccinations. Circulating antibody persisted for at least 14 months in these persons. The neutralizing antibody produced after one dose of C-84 vaccine in immune subjects and after booster doses in nonimmune subjects had broad cross-reactivity within the VEE virus complex. The C-84 vaccine induced a VEE virus-specific lymphocyte transformation response. The vaccine was safe, and immunologic results showed it to be highly antigenic in healthy immune and nomimmune adults.

100 项与 Venezuelan Equine Encephalitis DNA Vaccine(PharmaJet) 相关的药物交易

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