mRNA-1273.529 / Moderna - LARVOL DELTA

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P2 | N=1270 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Phase classification: P1/2 ➔ P2

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 (clinicaltrialsregister.eu) - P2/3 | N=3924 | Sponsor: ModernaTX, Inc.

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P1/2 | N=1270 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Nov 2023 | Trial primary completion date: Oct 2024 ➔ Nov 2023

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

A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - P2/3 | N=5404 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P1/2 | N=1270 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Mar 2026 ➔ Oct 2024 | Trial primary completion date: Mar 2026 ➔ Oct 2024

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

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 (clinicaltrials.gov) - P2/3 | N=3557 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - P2/3 | N=5404 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Apr 2023 ➔ Nov 2023 | Trial primary completion date: Apr 2023 ➔ Nov 2023

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

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 (clinicaltrials.gov) - P2/3 | N=3557 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

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

SARS-CoV-2 Omicron boosting induces de novo B cell response in humans. (PubMed, Nature) - "Nonetheless, by using a more targeted sorting approach we isolated mAbs that recognized the BA.1 spike protein but not the original SARS-CoV-2 spike from the mRNA-1273.529 boosted individuals. The latter mAbs were less mutated and recognized novel epitopes within the spike protein, suggesting a naïve B cell origin. Thus, SARS-CoV-2 booster immunizations in humans induce robust GC B cell responses and can generate de novo B cell responses targeting variant-specific epitopes."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P1/2 | N=1270 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

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

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P1/2 | N=1500 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Recruiting | N=1068 ➔ 1500

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

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P1/2 | N=1068 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

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

A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (clinicaltrials.gov) - P2/3 | N=4658 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

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

Boosting with variant-matched or historical mRNA vaccines protects against Omicron infection in mice. (PubMed, Cell) - "Nonetheless, the neutralizing antibody titers were higher, and lung viral burden and cytokines were slightly lower in mice boosted with mRNA-1273.529 and challenged with BA.1. Thus, boosting with mRNA-1273 or mRNA-1273.529 enhances protection against Omicron infection with limited differences in efficacy measured."

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

A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19 (clinicaltrials.gov) - P2/3 | N=3924 | Recruiting | Sponsor: ModernaTX, Inc. | N=2924 ➔ 3924

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