A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine

The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.

开始日期2019-03-18

申办/合作机构

Program for Appropriate Technology in Health

NCT03038243 / Withdrawn临床2期IIT

A Phase 2a/2b, Randomized, Double-blinded, Placebo-controlled, Trial to Assess the Safety, Immunogenicity and Efficacy of Inactivated Shigella Flexneri 2a Whole Cell (Sf2aWC) Vaccine Administered With and Without Double Mutant E. Coli Heat Labile Toxin (dmLT) in Healthy Adult Subjects

This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT. Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea. An adjuvant is something that is added to a vaccine to make it work better. The purpose of the study is to see if the vaccine will protect people from Shigella infection with or without an adjuvant called dmLT. About 72 healthy adults, ages 18-45, will participate in this study. The study will compare 2 different vaccination groups and 1 control group. Volunteers have an equal chance to be in any of the 3 groups. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 6 months.

开始日期2017-08-01

申办/合作机构

Program for Appropriate Technology in Health

NCT01509846 / Completed临床1期IIT

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Oral Inactivated Whole Cell Shigella Flexneri 2a Vaccine in Healthy Adult Subjects

This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC). Sf2aWC is a killed vaccine that is being made to prevent disease from Shigella., which causes bloody, watery diarrhea. Infants and children living in developing countries experience the greatest consequences of this disease. The purpose of this study is to find a dose of the vaccine that is safe, tolerable, and develops an immune response. About 82 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights for the first dose. Participants in Cohorts 2, 3, and 4 will not be required to stay overnight for the second and third doses. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples and documenting side effects. Participants will be involved in study related procedures for about 8 months.

开始日期2011-03-01

申办/合作机构

Program for Appropriate Technology in Health

100 项与福氏志贺菌2a灭活全细胞疫苗(Mucosis BV) 相关的临床结果

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100 项与福氏志贺菌2a灭活全细胞疫苗(Mucosis BV) 相关的转化医学

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100 项与福氏志贺菌2a灭活全细胞疫苗(Mucosis BV) 相关的专利（医药）

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项与福氏志贺菌2a灭活全细胞疫苗(Mucosis BV) 相关的文献（医药）

2016-04-01·Clinical and Vaccine Immunology

Evaluation of the Safety, Tolerability, and Immunogenicity of an Oral, Inactivated Whole-Cell Shigella flexneri 2a Vaccine in Healthy Adult Subjects

Article

作者: DeNearing, Barbara ; Sack, David A. ; Walker, Richard ; Dally, Len ; Bream, Jay ; Chakraborty, Subhra ; Harro, Clayton ; Bauers, Nicole ; Van de Verg, Lillian ; Flores, Jorge

ABSTRACTShigellacauses high morbidity and mortality worldwide, but there is no licensed vaccine for shigellosis yet. We evaluated the safety and immunogenicity of a formalin-inactivated whole-cellShigella flexneri2a vaccine, Sf2aWC, given orally to adult volunteers. In a double-blind, placebo-controlled trial, 82 subjects were randomized to receive three doses of vaccine in dose escalation (2.6 ± 0.8 × 108, × 109, × 1010, and × 1011vaccine particles/ml). Vaccine safety was actively monitored, and antigen-specific systemic and mucosal immune responses were determined in serum, antibody in lymphocyte supernatant (ALS), and fecal samples. Cytokines were measured in the serum. Sf2aWC was well tolerated and generally safe at all four dose levels. The vaccine resulted in a dose-dependent immune response. At the highest dose, the vaccine induced robust responses to lipopolysaccharide (LPS) in both serum and ALS samples. The highest magnitude and frequency of responses occurred after the first dose in almost all samples but was delayed for IgG in serum. Fifty percent of the vaccinees had a >4-fold increase in anti-LPS fecal antibody titers. Responses to invasion plasmid antigens (Ipa) were low. The levels of interleukin-17 (IL-17), IL-2, gamma interferon (IFN-γ), tumor necrosis factor alpha (TNF-α), and IL-10 were increased, and IL-8 was decreased immediately after first dose, but these changes were very transient. This phase I trial demonstrated that the Sf2aWC vaccine, a relatively simple vaccine concept, was safe and immunogenic. The vaccine elicited immune responses which were comparable to those induced by a live, attenuatedShigellavaccine that was protective in prior human challenge studies.

100 项与福氏志贺菌2a灭活全细胞疫苗(Mucosis BV) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
志贺氏菌感染	临床2期	-	Mucosis BV	-
腹泻	药物发现	美国	Program for Appropriate Technology in Health	2019-03-18

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01509846 (CTgov)	临床1期	志贺氏菌感染	82	Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose (Cohort 1)	構窪繭鏇獵鏇鬱齋選淵(壓夢艱願積壓餘蓋構艱) = 夢壓鑰鑰鹽醖鏇構艱鏇齋鑰鑰齋醖鬱蓋鹽範艱 (顧夢繭鑰艱鹽簾願鹹遞, 網夢衊齋鹹廠艱積選鬱 ~ 蓋構觸製衊觸簾願糧蓋) 更多	-	2021-08-11
				Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses (Cohort 2)	構窪繭鏇獵鏇鬱齋選淵(壓夢艱願積壓餘蓋構艱) = 蓋選遞積遞繭鹹願齋醖齋鑰鑰齋醖鬱蓋鹽範艱 (顧夢繭鑰艱鹽簾願鹹遞, 遞夢衊鏇壓壓簾觸鏇襯 ~ 範鑰餘艱憲鹽遞積齋蓋) 更多
NCT03869333 (CTgov)	临床1期	腹泻	58	Invaplex[AR-DETOX] (Invaplex[AR-Detox] 2.5 μg)	遞鹹淵窪淵艱遞醖齋鏇(獵衊觸鹽鏇廠鹽壓壓齋) = 網製範獵鏇憲積鬱願製膚簾憲齋積鬱夢蓋衊築 (糧鏇鹹憲選願願襯願鑰, 憲襯襯遞餘構壓夢憲網 ~ 製餘艱艱醖壓襯顧顧餘) 更多	-	2021-07-29
				Invaplex[AR-DETOX] (Invaplex[AR-Detox] 10 μg)	遞鹹淵窪淵艱遞醖齋鏇(獵衊觸鹽鏇廠鹽壓壓齋) = 簾積襯鹹鏇蓋網夢齋構膚簾憲齋積鬱夢蓋衊築 (糧鏇鹹憲選願願襯願鑰, 願製廠糧構醖艱蓋鏇鏇 ~ 壓鹽膚繭鹹範鑰積衊壓) 更多