COVI-VAC (CDX-CoV) / Codagenix, Serum Institute of India - LARVOL DELTA

Psoralen inactivated SARS-CoV2 vaccine protects Syrian hamsters from SARS-CoV2 induced lung disease (ASTMH 2025) - "These findings suggest that PsIV-COVID-19 vaccines (Vax1- 4) effectively protect hamsters from COVID-19 challenge and Advax-2 induces less inflammation compared to alum adjuvant. Further studies are required to assess safety and efficacy of PsIV-COVID-19 vaccines."

Late-breaking abstract • Preclinical • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19 (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Codagenix, Inc | Active, not recruiting ➔ Completed | N=30 ➔ 20

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19 (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Codagenix, Inc | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19 (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Codagenix, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19 (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Codagenix, Inc | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2022 ➔ Jan 2023

Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19 (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Codagenix, Inc

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Phase 1 Placebo-Controlled Trial of COVI-VACTM, an Intranasal, Live Attenuated COVID-19 Vaccine (IDWeek 2021) - "COVI-VAC appears safe and well tolerated in healthy young adults. Vaccination resulted in minimal viral shedding without sequence instability. Safety and shedding data supports continued development in a wider Phase 2/3 population."

Clinical • P1 data • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] COVI-VACTM, a live attenuated COVID-19 vaccine, provides single dose protection against heterologous challenge with SARS-CoV-2 Beta (B.1.351) in the Syrian golden hamster model (IDWeek 2021) - "COVI-VAC is protective against heterologous challenge with SARS-CoV-2 Beta. By presenting all viral antigens, COVI-VAC may be less affected by viral evolution than spike-based vaccines."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Scalable live-attenuated SARS-CoV-2 vaccine candidate demonstrates preclinical safety and efficacy. (PubMed, Proc Natl Acad Sci U S A) - "Highly attenuated COVI-VAC is protective at a single intranasal dose in a relevant in vivo model. This, coupled with its large-scale manufacturing potential, supports its potential use in mass vaccination programs."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=48; Active, not recruiting; Sponsor: Codagenix, Inc; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

First patient dosed with COVI-VAC, an intranasal COVID-19 vaccine candidate (European Pharmaceutical Review) - "The first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2...The study will evaluate the vaccine’s ability to provoke an immune response – this will be assessed by measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. Codagenix...expects to report initial data from the study by mid-2021. Pending results of the Phase I trial, it expects to begin advanced clinical testing in mid-2021."

New trial • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Codagenix, Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Codagenix, Serum Institute to begin UK trials of nasal COVID-19 vaccine in January (Reuters) - "Codagenix Inc and India’s Serum Institute said on Monday they have received regulatory approval in the United Kingdom to begin an early-stage trial of their single-dose, intranasal COVID-19 vaccine. The companies said 48 volunteers will be enrolled at three dose levels and expect to begin dosing the trial participants in the first week of January."

Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: Codagenix, Inc

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Serum Institute of India Initiates Manufacturing of Codagenix's Intranasal Live-Attenuated COVID-19 Vaccine Candidate (PRNewswire) - "Codagenix, Inc....today announced that the Serum Institute of India has begun manufacturing CDX-005....Codagenix, backed by investors Adjuvant Capital and TopSpin Partners, is collaborating with the Serum Institute of India....Codagenix expects to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020....Preclinical testing of a single, intranasal dose of CDX-005 in animals has yielded encouraging safety and efficacy signals, and with Serum Institute's financial and technical support, we expect to rapidly propel the vaccine into the clinic before the end of 2020....Serum Institute will initiate manufacturing for large-scale safety and efficacy studies, in addition to preparing to meet global vaccine supply requirements."

Clinical • Licensing / partnership • New P1 trial • Preclinical • Infectious Disease • Novel Coronavirus Disease