Delving into the Latest Updates on IMM-201 with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

+ [3]

Target-

Mechanism

Immunomodulators, Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication

Stress Disorders, Post-TraumaticTuberculosis

Originator Organization

Aeras Technologies LLC

Active Organization

Geisel School of Medicine

Aeras Technologies LLC

Immodulon Therapeutics Ltd.

+ [1]

Inactive Organization

Aeras Global TB Vaccine Foundation

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.

Start Date01 Feb 2014

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

NCT00052195 / CompletedPhase 2/3IIT

DARDAR Health Project (Disseminated Tuberculosis and HIV Infection)

A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

Start Date01 Sep 2001

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

100 Clinical Results associated with IMM-201

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100 Translational Medicine associated with IMM-201

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100 Patents (Medical) associated with IMM-201

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37

Literatures (Medical) associated with IMM-201

01 Dec 2020·BMC Infectious DiseasesQ3 · MEDICINE

The potential of CBC-derived ratios (monocyte-to-lymphocyte, neutrophil-to-lymphocyte, and platelet-to-lymphocyte) to predict or diagnose incident TB infection in Tanzanian adolescents

Q3 · MEDICINE

ArticleOA

Author: von Reyn, C Fordham ; Amour, Maryam ; Pallangyo, Kisali ; Rees, Christiaan A ; Matee, Mecky ; Munseri, Patricia ; Said, Jamila ; Pineros, Dwan B ; Magohe, Albert

AbstractBackgroundRatios of different immune cell populations (i.e., monocyte-to-lymphocyte, neutrophil-to-lymphocyte, and platelet-to-lymphocyte ratios) have been studied as a means of predicting future tuberculosis (TB) disease risk or to assist in the diagnosis of incident TB disease. No studies to-date, however, have evaluated the potential of these ratios to predict or assist in the diagnosis of incident TB infection - the first step in the natural history of TB disease.MethodsIn this prospective study, we evaluated the complete blood count (CBC)-derived metrics of monocyte-to-lymphocyte ratio (MLR), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR) as predictors of future TB infection risk or aids in the diagnosis of TB infection among 145 Tanzanian adolescents enrolled in the DAR-901 vaccine trial, using paired CBCs and interferon-gamma release assays (IGRAs) obtained at 0, 60 and 720 days after study enrollment.ResultsAt baseline, there were no significant differences between study participants who remained persistently IGRA negative throughout the study period and those who subsequently converted to IGRA positive with respect to MLR (0.18 vs 0.17, p = 0.10), NLR (0.88 vs 1.02, p = 0.08), or PLR (115 vs 120, p = 0.28). Similarly, no significant differences were noted with respect to MLR, NLR, and PLR between IGRA converters and time-matched negative controls at the time of IGRA conversion. With respect to other blood cell measures, however, there were modest but significant differences between IGRA negatives and IGRA converters with respect to red blood cell count (4.8 vs 4.6 × 106 cells/mcL, p = 0.008), hemoglobin (12.6 vs 12.3 g/dL, p = 0.01), and hematocrit (38.8 vs 37.8%, p = 0.005).ConclusionsIn contrast to prior studies that have suggested that the ratios of different immune cell populations are associated with development of TB disease, our present findings do not demonstrate an association between these ratios and the development of TB infection. However, decreased red blood cell measures were associated with the subsequent development of TB infection, suggesting either that dysregulation of iron metabolism may play a role in TB pathogenesis or that following TB infection, iron dysregulation may precede IGRA positivity.Trial registrationClinicaltrials.gov NCT02712424. Date of registration: March 14, 2016.

01 Oct 2020·VaccineQ3 · MEDICINE

DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: A randomized controlled, double-blind phase 2b trial

Q3 · MEDICINE

Article

Author: Arbeit, Robert D ; Adams, Lisa V ; Bailey-Kellogg, Chris ; von Reyn, C Fordham ; Wieland-Alter, Wendy ; Mackenzie, Todd ; Amour, Maryam ; Pallangyo, Kisali ; Rees, Christiaan A ; Nakamura, Keiko ; Magohe, Albert ; Horsburgh, C Robert ; Munseri, Patricia ; Matee, Mecky ; Maro, Isaac ; Said, Jamila ; Tvaroha, Susan

BACKGROUNDSRL172 prevented disease due to Mycobacterium tuberculosis in a Phase 3 trial. DAR-901 represents a scalable manufacturing process for SRL172. We sought to determine if DAR-901 would prevent infection with M. tuberculosis among BCG-primed adolescents age 13-15 years in Tanzania.METHODSAdolescents with a negative T- SPOT.TB^R interferon gamma release assay (IGRA) were randomized 1:1 to three intradermal injections of DAR-901 or saline placebo at 0, 2 and 4 months. Repeat IGRAs were performed at 2 months, and at 1, 2, and 3 years. The primary efficacy outcome was time to new TB infection (IGRA conversion to positive); the secondary outcome was time to persistent TB infection (IGRA conversion with repeat positive IGRA).RESULTSAmong 936 participants screened 667 were eligible and randomized to their first dose of vaccine or placebo (safety cohort). At 2 months, 625 participants remained IGRA-negative and were scheduled for the additional two doses (efficacy cohort). DAR-901 was safe and well-tolerated. One DAR-901 recipient developed a vaccine site abscess. Neither the primary nor secondary endpoints differed between the two treatment arms (p = 0.90 and p = 0.20, respectively). DAR-901 IGRA converters had median responses to ESAT-6 of 50.1 spot-forming cells (SFCs) vs. 19.6 SFCs in placebo IGRA converters (p = 0.03).CONCLUSIONSA three-dose series of 1 mg DAR-901 was safe and well-tolerated but did not prevent initial or persistent IGRA conversion. DAR-901 recipients with IGRA conversion demonstrated enhanced immune responses to ESAT-6. Since protection against disease may require different immunologic responses than protection against infection a trial of DAR-901 to prevent TB disease is warranted.TRIAL REGISTRATIONThe trial is registered at ClinicalTrials.gov as NCT02712424.

01 Dec 2018·BMC Public HealthQ3 · MEDICINE

Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial

Q3 · MEDICINE

ArticleOA

Author: Fordham von Reyn, C ; Dixit, Apoorva ; Lahey, Timothy ; Craig, Sienna R

BACKGROUNDThe current vaccine against tuberculosis, BCG, is effective when given in most TB-endemic countries at birth but has diminished efficacy against pulmonary TB after 15-20 years. As a result, new booster vaccines for adolescents and adults are being developed to realize the World Health Organization target of global elimination of TB by 2035. Multiple TB candidates thus are in active clinical development.METHODSOne of these, DAR-901, is advancing in human clinical trials. These clinical trials are conducted in BCG immunized adults with and without HIV infection in order to assess safety and efficacy among the people most in need of a new vaccine. A Phase I dose escalation trial of DAR-901 in BCG-immunized adults with or without HIV infection was conducted between 2014 and 2016. This offered an unusual opportunity to qualitatively examine why foreign-born adults living in the United States - a poorly studied population - decide to participate, or not, in clinical trials.RESULTSWe conducted a qualitative study of individuals who were recruited to participate in this Phase I vaccine trial, interviewing those who agreed and declined to participate. We found diverse motivations for participation or refusal; varied understandings of tuberculosis and vaccines; and complex views about how 'informed consent' can be at odds with cultural understandings of power, authority, and medical decision-making. These dynamics included: knowledge (direct or indirect) of tuberculosis, a desire to be altruistic and simultaneous hopes for personal gain as well as concerns over what remuneration for participation could mean, the importance of personal relationships with care providers in shaping volunteerism, concerns over privacy, and evidence of how culture and history shape medical decision-making.CONCLUSIONSThis US-based trial, aimed at addressing a crucible global health issue, raises productive questions about the interface between altruism and scepticism regarding clinical research participation.TRIAL REGISTRATIONNCT02063555 .

100 Deals associated with IMM-201

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	-	Aeras Technologies LLC	-
HIV Infections	Phase 3	-	Immodulon Therapeutics Ltd.	-
HIV Infections	Phase 3	-	Silence Therapeutics Plc	-
HIV Infections	Phase 3	-	Geisel School of Medicine	-
Tuberculosis	Phase 2	ZM	-	-
Tuberculosis	Phase 2	ZM	-	-
Tuberculosis	Phase 2	MW	-	-
Tuberculosis	Phase 2	ZA	-	-
Tuberculosis	Phase 2	ZA	-	-
Tuberculosis	Phase 2	MW	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02712424 (DAR-PIA, CTgov)	Phase 2	Tuberculosis	625	DAR-901 (DAR-901)	jrpjswcdcs(eokthkbumt) = wjqbwfhqon ssvhkffxgz (cmktpmdncb, cocphfhndp - ebiqzlxuwl) View more	-	11 May 2021
				Sterile saline placebo (Placebo)	jrpjswcdcs(eokthkbumt) = dmkvzhpfwk ssvhkffxgz (cmktpmdncb, cnprsbcunh - uwjmrkcpde) View more
NCT02712424 (Pubmed) Manual	Phase 2	Tuberculosis	667	DAR-901 vaccine	bdobrypyqa(zrnyiagpjy): P-Value = 0.90	Negative	27 Oct 2020
				Placebo
NCT02063555 (Pubmed \| J Biol Chem)	Phase 1	-	59	DAR-901	gcrxploanq(zjegqxeypr) = dcbuowppwb onfqsplpdr (uajzqsnlkc ) View more	-	01 Jan 2017
				DAR-901 (BCG)	gcrxploanq(zjegqxeypr) = jgwipgrdnl onfqsplpdr (uajzqsnlkc ) View more