Phase Ia/b Double-blind, Placebo-controlled, Dose Escalating Safety Study of Detoxified Shigella Flexneri 2a Artificial Invasin Complex (InvaplexAR-Detox) Vaccine Formulated With and Without dmLT Adjuvant Given Intramuscularly to Healthy Adults in the Netherlands and Zambia

The goal of this clinical trial is to test a new Shigella vaccine (InvaplexAR-DETOX) in combination with a new adjuvant (dmLT) in healthy participants. The main questions it aims to answer are:
Is the new Shigella vaccine (with and without the new adjuvant) safe and well tolerated?
How wel does the new Shigella vaccine stimulate the immune system in combination with the new adjuvant, and without the new adjuvant?
Participants will receive three vaccinations at 28-day intervals. Researchers will compare the results of participants vaccinated with the vaccine in combination with the adjuvant to the results of participants vaccinated with the vaccine only and to the results of participants vaccinated with a placebo (fake vaccine).

开始日期2023-11-01

申办/合作机构

Academisch Ziekenhuis Leiden

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100 项与 InvaplexAR-Detox 相关的临床结果

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100 项与 InvaplexAR-Detox 相关的转化医学

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100 项与 InvaplexAR-Detox 相关的专利（医药）

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项与 InvaplexAR-Detox 相关的文献（医药）

Vaccines3区 · 医学

From Concept to Clinical Product: A Brief History of the Novel Shigella Invaplex Vaccine’s Refinement and Evolution

3区 · 医学

ReviewOA

作者: Clarkson, Kristen A. ; Oaks, Edwin V. ; Turbyfill, K. Ross ; Kaminski, Robert W.

The Shigella invasin complex or Invaplex vaccine is a unique subunit approach to generate a protective immune response. Invaplex is a large, macromolecular complex consisting of the major Shigella antigens: lipopolysaccharide (LPS) and the invasion plasmid antigen (Ipa) proteins B and C. Over the past several decades, the vaccine has progressed from initial observations through pre-clinical studies to cGMP manufacture and clinical evaluations. The Invaplex product maintains unique biological properties associated with the invasiveness of virulent shigellae and also presents both serotype-specific epitopes, as well as highly conserved invasin protein epitopes, to the immunized host. The vaccine product has evolved from a native product isolated from wild-type shigellae (native Invaplex) to a more defined vaccine produced from purified LPS and recombinant IpaB and IpaC (artificial Invaplex). Each successive “generation” of the vaccine is derived from earlier versions, resulting in improved immunogenicity, homogeneity and effectiveness. The current vaccine, detoxified artificial Invaplex (InvaplexAR-Detox), was developed for parenteral administration by incorporating LPS with under-acylated lipid A. InvaplexAR-Detox has demonstrated an excellent safety and immunogenicity profile in initial clinical studies and is advancing toward evaluations in the target populations of children and travelers to endemic countries.

100 项与 InvaplexAR-Detox 相关的药物交易

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