recombinant parainfluenza virus 5 vaccine (BLB101) / University of Georgia, CyanVac LLC, The University of Iowa - LARVOL DELTA

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults (clinicaltrials.gov) - P2 | N=432 | Active, not recruiting | Sponsor: CyanVac LLC | Recruiting ➔ Active, not recruiting | N=10016 ➔ 432

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: CyanVac LLC | Completed ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Jun 2028 | Trial primary completion date: Oct 2024 ➔ Jun 2027

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=227 | Completed | Sponsor: CyanVac LLC | Trial primary completion date: Jul 2024 ➔ Oct 2024

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Safety and immunogenicity of intranasal parainfluenza virus type 5 (PIV5)-vectored COVID-19 vaccine in adults and teens in an open-label phase 1 trial. (PubMed, Sci Adv) - "Significantly lower rates of symptomatic COVID-19 infection were reported in groups receiving high-dose CVXGA1 (HD) compared to that in the group receiving low-dose CVXGA1 (LD) during the SARS-CoV-2 delta and omicron waves. The data indicate that CVXGA1 is a potentially effective intranasal COVID-19 vaccine that is immunogenic with minimal reactogenicity."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8

Efficacy of parainfluenza virus 5 (PIV5)-vectored intranasal COVID-19 vaccine as a single dose primer and booster against SARS-CoV-2 variants. (PubMed, J Virol) - "This work demonstrates the protective efficacy and strong boosting effect of an intranasal viral-vectored vaccine against SARS-CoV-2 variants in hamsters. Our intranasal vaccine can act as an effective booster for individuals already 58 vaccinated against SARS-CoV-2."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A parainfluenza virus 5 (PIV5)-vectored intranasal SARS-CoV-2 vaccine (CVXGA1) elicits protective and long-lasting immunity in nonhuman primates. (PubMed, J Virol) - "This work demonstrates that intranasal, PIV5 viral-vectored SARS-CoV-2 vaccine CVXGA1 induces mucosal immunity and long-lasting cellular and humoral immunity that protects African green monkeys from SARS-CoV-2 challenge. The ability of our intranasal vaccine to elicit long-lasting mucosal, cellular, and humoral immunity against SARS-CoV-2 indicates great promise of the PIV5-vectored COVID-19 vaccine for further clinical development."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG • IL13 • TNFA

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults (clinicaltrials.gov) - P2 | N=10016 | Recruiting | Sponsor: CyanVac LLC

New P2 trial • Infectious Disease • Novel Coronavirus Disease

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=227 | Completed | Sponsor: CyanVac LLC | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: CyanVac LLC | Trial primary completion date: Apr 2024 ➔ Jul 2024

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: CyanVac LLC | Recruiting ➔ Active, not recruiting | N=400 ➔ 227

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

CVXGA1-001: Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: CyanVac LLC | Active, not recruiting ➔ Completed

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

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: CyanVac LLC

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

CVXGA1-001: Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: CyanVac LLC | Trial completion date: Jun 2024 ➔ Dec 2023

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

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA1 Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: CyanVac LLC | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2023 ➔ Jun 2023

Enrollment open • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA1 Intranasal COVID Vaccine in Healthy Adults (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: CyanVac LLC

New P2 trial • Infectious Disease • Novel Coronavirus Disease

CVXGA1-001: Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: CyanVac LLC | Recruiting ➔ Active, not recruiting

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

CVXGA1-001: Phase 1 Study of Intranasal PIV5-vectored COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: CyanVac LLC | N=60 ➔ 80 | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: Jun 2022 ➔ Jan 2024

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

CVXGA1-001: Phase 1 Study of Intranasal PIV5-vectored COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: CyanVac LLC | Trial primary completion date: Mar 2022 ➔ Jun 2022

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CVXGA1-001: Phase 1 Study of Intranasal PIV5-vectored COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: CyanVac LLC; Trial completion date: Nov 2022 ➔ Feb 2023; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CVXGA1-001: Phase 1 Study of Intranasal PIV5-vectored COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: CyanVac LLC; Not yet recruiting ➔ Recruiting

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

CVXGA1-001: Phase 1 Intranasal Parainfluenza Virus Type 5-SARS CoV-2 S Vaccine in Healthy Adults (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: CyanVac LLC

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

Successful MERS vaccine in mice may hold promise for COVID-19 vaccine (University of Iowa) - "The vaccine uses a harmless virus to deliver a MERS coronavirus protein into cells to generate an immune response, and may hold promise for developing vaccines against other coronaviruses diseases, including COVID-19....And finally, the vaccine in the current study was the most effective MERS vaccine to date in animal models of the disease...the research team included...Stanley Perlman..."

Media quote