COVI-VAC COVID-19 Vaccine Description
COVI-VAC COVID-19 is an intranasal, live-attenuated vaccine candidate generated using Codagenix’s proprietary deoptimization technology. COV-VAC-COVID-19 is designed to produce immunity against all SARS-CoV-2 proteins, not just the spike surface protein.
Live-attenuated vaccines elicit a robust immune response and are associated with long-lasting cellular immunity.
The Codagenix vaccine can be grown easily in cell culture, scalable, and produced in quantities sufficient to make a significant contribution to meeting global needs.
Intranasal administration does not require needles or specially trained healthcare providers and is thus uniquely suited for a mass immunization campaign.
Codagenix is partnered with the Serum Institute of India, the largest vaccine manufacturer in the world by doses sold, for vaccine production and global distribution.
Partnering with the Serum Institute offers Codagenix unrivaled manufacturing capacity and expertise.
On January 11, 2021, J. Robert Coleman, Ph.D., CEO of Codagenix, said in a press statement: "Dosing the first patient in the Phase 1 trial is an important milestone in the development of COVI-VAC, which we believe has significant advantages over other vaccines against COVID-19. Importantly, as a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus. This could prove critical as new variants of SARS-CoV-2 have begun to emerge."
Codagenix is a clinical-stage synthetic biology company that uses software to recode viruses' genomes, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Codagenix’s recoded vaccine candidates are a perfect antigenic match to the target virus and induce a robust immune response to all viral antigens.
COVI-VAC COVID-19 Vaccine Indication
CodaVax-COVID is indicated to prevent infection from SARS-CoV-2, the virus that causes COVID-19.
COVI-VAC COVID-19 Vaccine News
January 11, 2021 - Codagenix and Serum Institute of India Initiate Dosing in Phase 1 Trial of COVI-VAC, a Single Dose, Intranasal, Live Attenuated Vaccine for COVID-19. The first patient has been dosed in Phase 1 clinical trial of COVI-VAC. The Phase 1 trial will evaluate a total of 48 volunteers at multiple dose levels to determine the safety and tolerability of COVI-VAC.
October 19, 2020 - Serum Institute has begun manufacturing the intranasal Covid-19 vaccine, reported local media.
September 29, 2020 - A further collaboration among the Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, Gavi, and the Bill & Melinda Gates Foundation will accelerate the manufacture and delivery of up to 100 million doses of safe and effective COVID-19 vaccines for India and low-and middle-income countries as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility.
September 22, 2020 - Codagenix, Inc. announced that the Serum Institute of India has begun manufacturing CDX-005, its intranasal, live-attenuated vaccine candidate SARS-CoV-2, the virus that causes COVID-19. Preclinical animal studies have been completed, and Codagenix expects to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020.
June 18, 2020 - Codagenix, Inc. announced the successful synthesis of a readily-scalable live-attenuated vaccine candidate against COVID-19. The vaccine, CDX-005, is currently undergoing safety and efficacy studies in animals and appears markedly attenuated compared to wild-type SARS-CoV-2, the virus that causes COVID-19, with pre-clinical data expected by early July.
COVI-Vac COVID-19 Clinical Trials
Clinical Trial NCT04619628: Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19
This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years.
Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo.
Drops administer COVI-VAC or placebo into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received.
To assess the vaccine's safety, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose.
Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded.
Blood samples and intranasal samples will be collected to assess the vaccine's immune response.