AV-COVID-19

Overview

AV-COVID-19 is a vaccine composed of autologous dendritic cells loaded with SARS-CoV-2 antigens and with or without Granulocyte-macrophage colony-stimulating factor (GM-CSF). The vaccine is created from the receiving patients’ isolated peripheral blood monocytes. The monocytes are then differentiated in vitro into dendritic cells with IL-4 and GM-CSF, incubated with SARS-CoV-2 antigens prior to administration. The vaccine was developed and tested by Aivita Biomedical, Inc.. As of July 2020, the company is pursuing an adaptive Phase IB-II Randomized Clinical Trial (NCT04386252) to test the vaccine.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection	2016/02/04	NCT02673489	Phase 3	Completed	Bristol-Myers Squibb
Study of Drug Combination on Pharmacokinetics in Healthy Volunteers	2014/06/26	NCT02175602	Phase 1	Completed	Bristol-Myers Squibb
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C	2014/04/25	NCT02123654	Phase 3	Completed	Bristol-Myers Squibb
To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet	2014/04/09	NCT02108639	Phase 1	Completed	Bristol-Myers Squibb
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325	2014/03/26	NCT02095860	Phase 1	Completed	Bristol-Myers Squibb
Study to Evaluate the Drug Interaction Between Dolutegravir (DTG) and Daclatasvir (DCV) in Healthy Adult Subjects	2014/03/10	NCT02082808	Phase 1	Completed	ViiV Healthcare
Drug Interaction & Methadone & Buprenorphine	2014/01/27	NCT02045693	Phase 1	Completed	Bristol-Myers Squibb
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects	2014/01/27	NCT02045966	Phase 1	Completed	Bristol-Myers Squibb

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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Overview

Indication

Associated Conditions

Clinical Trials

FDA Drug Approvals

EMA Drug Approvals

HSA Drug Approvals

NMPA Drug Approvals

PPB Drug Approvals

TGA Drug Approvals

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