AGS-v(National Institute of Allergy & Infectious Diseases)(AGS-v(National Institute of Allergy & Infectious Diseases))

概要

基本信息

药物类型

预防性疫苗

别名

AGS v、AGS-v PLUS

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

病毒感染

非在研适应症

蚊媒病毒热

原研机构

National Institute of Allergy & Infectious Diseases

在研机构

Imutex Ltd.

非在研机构

National Institute of Allergy & Infectious Diseases

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 AGS-v(National Institute of Allergy & Infectious Diseases) 相关的临床试验

NCT04009824

/ Completed临床1期IIT

Randomized, Double-Blind, Placebo-Controlled, Single-Center, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.

开始日期2019-07-08

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT03055000

/ Completed临床1期IIT

Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v, a Universal Mosquito-Borne Disease Vaccine

Background:
Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.
Objective:
To see if the AGS-v vaccine is safe in humans and how it affects the immune system.
Eligibility:
Healthy adults ages 18-50
Design:
Participants will be screened another study.
Participants will be randomly assigned to get either the vaccine with a booster vaccine, the vaccine without the booster, or a placebo. These are given through a needle in the upper arm.
Participants will have visits that include medical history, physical exam, and blood and urine tests:
Baseline: They will get the vaccine and be monitored for 2 hours.
Follow-up visits 1 and 2 weeks after baseline.
Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.
Follow-up visits 1 and 2 weeks after booster visit.
Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the feeding.
Phone follow-up a few days after the mosquito feeding.
After the feeding visit, 5 follow-up visits about every 2 months
Participants will keep a symptom diary for 7 days after each vaccine. They will record their temperature. They will measure any redness around the injection site. They will document and if possible photograph any mosquito bites they get.

开始日期2017-02-15

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 AGS-v(National Institute of Allergy & Infectious Diseases) 相关的临床结果

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100 项与 AGS-v(National Institute of Allergy & Infectious Diseases) 相关的转化医学

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100 项与 AGS-v(National Institute of Allergy & Infectious Diseases) 相关的专利（医药）

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3

项与 AGS-v(National Institute of Allergy & Infectious Diseases) 相关的文献（医药）

2022-12-01·eBioMedicine

Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases: A randomized, double-blind, placebo-controlled Phase 1 trial

Article

作者: Meneses, Claudio R ; Lacsina, Joshua R ; Memoli, Matthew J ; Oliveira, Fabiano ; Short, Mara T ; Pleguezuelos, Olga ; Laurens, Matthew B ; Friedman-Klabanoff, DeAnna J ; Wilson, Timothy R ; Stoloff, Gregory ; Valenzuela, Jesus G ; Kamhawi, Shaden ; Birkhold, Megan ; Mateja, Allyson ; Hunsberger, Sally

BACKGROUNDImmunity to mosquito salivary proteins could provide protection against multiple mosquito-borne diseases and significantly impact public health. We evaluated the safety and immunogenicity of AGS-v PLUS, a mosquito salivary peptide vaccine, in healthy adults 18-50 years old.METHODSWe conducted a randomized, double-blind, placebo-controlled Phase 1 study of AGS-v PLUS administered subcutaneously on Days 1 and 22 at the Center for Vaccine Development and Global Health, Baltimore, MD, USA. Participants were block randomized 1:1:1:1:1 to two doses saline placebo, two doses AGS-v PLUS, AGS-v PLUS/ISA-51 and saline placebo, two doses AGS-v PLUS/ISA-51, or two doses AGS-v PLUS/Alhydrogel. Primary endpoints were safety (all participants receiving ≥1 injection) and antibody and cytokine responses (all participants with day 43 samples), analysed by intention to treat.FINDINGSBetween 26 August 2019 and 25 February 2020, 51 participants were enrolled and randomized, 11 into the single dose AGS-v PLUS/ISA-51 group and ten in other groups. Due to COVID-19, 15 participants did not return for day 43 samplings. Participants experienced no treatment-emergent or serious adverse events. All solicited symptoms in 2/10 placebo recipients and 22/41 AGS-v PLUS recipients after dose one and 1/10 placebo recipients and 22/41 AGS-v PLUS recipients after dose two were mild/moderate except for one severe fever the day after vaccination (placebo group). Only injection site pain was more common in vaccine groups (15/51 after dose 1 and 11/51 after dose 2) versus placebo. Compared to placebo, all vaccine groups had significantly greater fold change in anti-AGS-v PLUS IgG and IFN-ɣ from baseline.INTERPRETATIONAGS-v PLUS had favourable safety profile and induced robust immune responses. Next steps will determine if findings translate into clinical efficacy against mosquito-borne diseases.FUNDINGUK Department of Health and Social Care.

2020-06-01·The Lancet1区 · 医学

Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial

1区 · 医学

Article

作者: Coutinho-Abreu, Iliano V ; Czajkowski, Lindsay ; Herbert, Samantha ; Stoloff, Gregory ; Hunsberger, Sally ; Reed, Susan ; Kamhawi, Shaden ; Valenzuela, Jesus G ; Baus, Holly Ann ; Mateja, Allyson ; Pleguezuelos, Olga ; Han, Alison ; Meneses, Claudio ; Athota, Rani ; Cervantes-Medina, Adriana ; James, Emma ; Manning, Jessica E ; Memoli, Matthew J ; Oliveira, Fabiano ; Rosas, Luz Angela

BACKGROUNDIn animal models, immunity to mosquito salivary proteins protects animals against mosquito-borne disease. These findings provide a rationale to vaccinate against mosquito saliva instead of the pathogen itself. To our knowledge, no vector salivary protein-based vaccine has been tested for safety and immunogenicity in humans. We aimed to assess the safety and immunogenicity of Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine derived from four A gambiae salivary proteins, in humans.METHODSIn this randomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites. Participants were randomly assigned (1:1:1), using block randomisation and a computer-generated randomisation sequence, to treatment with either 200 nmol of AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo. Participants and clinicians were masked to treatment assignment. Participants were given a subcutaneous injection of their allocated treatment at day 0 and day 21, followed by exposure to feeding by an uninfected Aedes aegypti mosquito at day 42 to assess subsequent risk to mosquito bites in a controlled setting. The primary endpoints were safety and immunogenicity at day 42 after the first immunisation. Participants who were given at least one dose of assigned treatment were assessed for the primary endpoints and analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03055000, and is closed for accrual.FINDINGSBetween Feb 15 and Sept 10, 2017, we enrolled and randomly assigned 49 healthy adult participants to the adjuvanted vaccine (n=17), vaccine alone (n=16), or placebo group (n=16). Five participants did not complete the two-injection regimen with mosquito feeding at day 42, but were included in the safety analyses. No systemic safety concerns were identified; however, one participant in the adjuvanted vaccine group developed a grade 3 erythematous rash at the injection site. Pain, swelling, erythema, and itching were the most commonly reported local symptoms and were significantly increased in the adjuvanted vaccine group compared with both other treatment groups (nine [53%] of 17 participants in the adjuvanted vaccine group, two [13%] of 16 in the vaccine only group, and one [6%] of 16 in the placebo group; p=0·004). By day 42, participants who were given the adjuvanted vaccine had a significant increase in vaccine-specific total IgG antibodies compared with at baseline than did participants who were give vaccine only (absolute difference of log₁₀-fold change of 0·64 [95% CI 0·39 to 0·89]; p=0·0002) and who were given placebo (0·62 [0·34 to 0·91]; p=0·0001). We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log₁₀ ratio of vaccine peptide-stimulated vs negative control 0·17 [95% CI 0·061 to 0·27]; p=0·009) but we saw no difference between the IFN-γ production in the vaccine only group compared with the placebo group (0·022 [-0·072 to 0·116]; p=0·63).INTERPRETATIONAGS-v was well tolerated, and, when adjuvanted, immunogenic. These findings suggest that vector-targeted vaccine administration in humans is safe and could be a viable option for the increasing burden of vector-borne disease.FUNDINGOffice of the Director and the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases, and National Institutes of Health.

2017-07-01·Biomedicine & Pharmacotherapy2区 · 医学

Recent trends in ZikV research: A step away from cure

2区 · 医学

Review

作者: Imam, Nikhat ; Ishrat, Romana ; Malik, Md Zubbair ; Ali, Shahnawaz ; Farooqui, Anam ; Alam, Aftab

Zika virus (ZikV) is a member of the Flaviviridae virus family, genus Flavivirus has emerged as a potential threat to human health worldwide. Consequences of vertical infections includes microcephaly with brain and eye anomalies, and adult infections includes Guillain-Barrésyndrome (GBS), brain ischemia, myelitis and meningoencephalitis. To develop a better treatment, many efforts are being made, like drug-repurposing concept for FDA-approved drugs for antiviral activity are screened against ZikV infection and emerging as a promising alternative to expedite drug development and various vaccines like DNA, ZPIV, LAIV, mRNA and AGS-v vaccines have been designed and in under clinical trial phases. Moreover, few pharmacological agents like Mycophenolicacid, Niclosamide, PHA-690509, Emricasan and Bortezomib are most potent anti-ZikV candidates and highly effective single or combining treatment with these drugs. This article reviews the ZikV illness, transmission patterns, pathophysiology of disease, global efforts, challenges and the prospects for the development of vaccines and antiviral agents.

100 项与 AGS-v(National Institute of Allergy & Infectious Diseases) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
蚊媒病毒热	临床2期	美国	National Institute of Allergy & Infectious Diseases	2017-02-15
病毒感染	临床1期	-	Imutex Ltd.	-

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临床结果

适应症

分期

评价

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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


NCT04009824 (CTgov)	临床1期	媒介传播疾病	51	Saline Placebo (Group 1: Saline Placebo)	衊繭遞膚觸襯糧構蓋醖(鬱憲鏇窪鑰觸餘鏇築艱) = 窪衊獵夢願製鹹觸艱構鏇獵壓繭選鬱衊獵願顧 (積廠獵積鏇鑰鏇選鏇糧, 壓醖廠簾膚鬱蓋觸淵鬱 ~ 齋構鬱淵網積鏇餘醖網) 更多	-	2022-04-28
				AGS-v PLUS+Vaccine (Group 2: AGS-v PLUS Non-Adjuvanted)	衊繭遞膚觸襯糧構蓋醖(鬱憲鏇窪鑰觸餘鏇築艱) = 廠壓獵鑰觸衊鬱鬱獵繭鏇獵壓繭選鬱衊獵願顧 (積廠獵積鏇鑰鏇選鏇糧, 繭範簾觸繭窪餘艱願構 ~ 廠觸簾築築艱艱選襯衊) 更多
NCT03055000 (CTgov)	临床1期	蚊媒病毒热	49	AGS-v (AGS-v)	積夢壓壓鬱願窪觸鹽膚(鹽襯蓋淵廠遞範範觸醖) = 夢憲壓醖鏇鏇廠範積選築餘淵憲鑰壓簾積鏇糧 (遞繭夢廠夢構夢繭襯獵, 鑰構鹽鏇積願觸廠醖鹽 ~ 餘繭範壓鬱艱醖築廠蓋) 更多	-	2020-08-03
				AGS-v + adjuvant (AGS-v With Adjuvant)	積夢壓壓鬱願窪觸鹽膚(鹽襯蓋淵廠遞範範觸醖) = 蓋獵構憲鑰觸衊膚壓醖築餘淵憲鑰壓簾積鏇糧 (遞繭夢廠夢構夢繭襯獵, 壓製襯遞顧鏇淵膚憲淵 ~ 網壓襯鏇餘獵範鹽選憲) 更多