mRNA-1273.351 / 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

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

Mapping SARS-CoV-2 antigenic relationships and serological responses. (PubMed, Science) - "Here, we used antigenic cartography to analyze patterns of cross-reactivity among 21 variants and 15 groups of human sera obtained after primary infection with 10 different variants or after messenger RNA (mRNA)-1273 or mRNA-1273.351 vaccination. Quantifying changes in response breadth over time and with additional vaccine doses, our results show the largest increase between 4 weeks and >3 months after a second dose. We found changes in immunodominance of different spike regions, depending on the variant an individual was first exposed to, with implications for variant risk assessment and vaccine-strain selection."

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) | 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

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

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults (clinicaltrials.gov) - P1 | N=135 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | 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=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

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

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

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (clinicaltrials.gov) - P1/2 | N=1500 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1/2 trial • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older (clinicaltrials.gov) - P2a; N=660; Completed; Sponsor: ModernaTX, Inc.; Active, not recruiting ➔ Completed

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

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults (clinicaltrials.gov) - P1; N=135; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Active, not recruiting; N=210 ➔ 135

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

Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older (clinicaltrials.gov) - P2a; N=660; Active, not recruiting; Sponsor: ModernaTX, Inc.; Trial primary completion date: Mar 2021 ➔ Nov 2021

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

NIH Clinical Trial Evaluating Moderna COVID-19 Variant Vaccine Begins (National Institute of Health) - "The Phase 1 clinical trial will enroll participants at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, Emory University in Atlanta, Vanderbilt University Medical Center (VUMC) in Nashville, and Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati. The trial is led by investigator...Nadine Rouphael, M.D..."

Clinical • Novel Coronavirus Disease

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults (clinicaltrials.gov) - P1; N=210; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Not yet recruiting ➔ Recruiting

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

Moderna COVID-19 Vaccine Retains Neutralizing Activity Against Emerging Variants First Identified in the U.K. and the Republic of South Africa (Businesswire) - "Moderna Inc....today announced results from in vitro neutralization studies of sera from individuals vaccinated with Moderna COVID-19 Vaccine showing activity against emerging strains of SARS-CoV-2. Vaccination with the Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant relative to prior variants....The Company is advancing mRNA-1273.351 into preclinical studies and a Phase 1 study in the U.S...."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study (Businesswire) - "Moderna, Inc....announces that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351...and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial...First, the Company is evaluating booster doses of vaccine to increase neutralizing immunity against the variants of concern....Moderna plans to evaluate three approaches to boosting, including: A variant-specific booster candidate, mRNA-1273.351...at the 50 µg dose level and lower; A multivalent booster candidate, mRNA-1273.211...and mRNA-1273.351 in a single vaccine at the 50 µg dose level and lower; A third dose of mRNA-1273...as a booster at the 50 µg dose level....Second, the Company plans to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for those who are seronegative. These candidates will be evaluated in a two-dose series at the 100 µg dose level and lower."

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Moderna Announces First Participants Dosed in Study Evaluating COVID-19 Booster Vaccine Candidates (Businesswire) - "...the first participants have been dosed with the Company’s modified COVID-19 vaccines...An amendment to the Phase 2 study will enroll 60 participants previously vaccinated with mRNA-1273 to receive a single booster dose of either: 20 µg of a variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant first identified in the Republic of South Africa (N=20); 50 µg of mRNA-1273.351 (N=20); 50 µg of a multivalent booster candidate, mRNA-1273.211...In parallel, NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to assess the monovalent and multivalent modified mRNA-1273 vaccines..."

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