mRNA-1283 / Moderna - LARVOL DELTA

The Potential Impact of COVID-19 Vaccine Efficacy and Vaccination Coverage on Health Equity Among United States (US) Older Adults (ISPOR 2025) - "Vaccine efficacy estimates for mRNA-1283 and the market-mix of current mRNA-1273 and BNT162b2 vaccines were derived from the NextCOVE trial, real-world data, and an indirect treatment comparison. Results suggest that mRNA-1283 may reduce health inequalities among US adults ≥65-years compared to current vaccines. The similar magnitude of equity impact from higher vaccine efficacy and from increasing COVID-19 VCR underscores the need for including differences in vaccine efficacy in health equity evaluations and policy."

Clinical • Infectious Disease • Novel Coronavirus Disease

The Potential Clinical Impact of the Moderna Next-Generation COVID-19 mRNA-1283 Vaccine in United States (US) Adults (ISPOR 2025) - "mRNA-1283 vaccine effectiveness (VE) against COVID-19 infection and hospitalization was estimated considering the relative VE (rVE) of mRNA-1283 vs mRNA-1273 based on clinical trial data and 2023/2024 real-world VE for mRNA-1273. Results suggest a Fall 2024/2025 updated mRNA-1283 vaccine campaign could significantly reduce hospitalizations, particularly among US adults 65+ compared to no vaccination or updated BNT162b2 vaccination. The findings underscore the importance of continued efforts to increase COVID-19 VCR to maximize these clinical benefits."

Clinical • Infectious Disease • Novel Coronavirus Disease

Indirect comparison of the relative vaccine effectiveness of mRNA-1283 vs. BNT162b2 vaccines against symptomatic COVID-19 among US adults. (PubMed, Curr Med Res Opin) - "To indirectly compare the effectiveness of mRNA-1283 and BNT162b2 against symptomatic COVID-19 among adults in the U.S. A targeted literature review was conducted to identify relevant studies comparing the mRNA-1273 and BNT162b2 bivalent vaccines. This analysis provides consistent and statistically significant evidence indicating the next-generation mRNA-1283 vaccine is more effective in preventing symptomatic COVID-19 than BNT162b2, with the largest effect in individuals aged ≥65. Consistent results across sensitivity analyses underscore the robustness of the findings, offering important evidence to inform vaccination decisions by policymakers, providers, and payers."

Journal • Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain andN-Terminal Domain mRNA Vaccine. (PubMed, J Infect Dis) - P2 | "mRNA-1283 was well tolerated and exhibited improved immunogenicity compared to mRNA-1273."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

NextCOVE: A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P3 | N=14246 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2024 ➔ Apr 2025 | Trial primary completion date: Aug 2024 ➔ Apr 2025

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

mRNA-based Vaccines - Global Approach, Challenges, and Could Be a Promising Wayout for Future Pandemics. (PubMed, Pharm Dev Technol) - "mRNA-based vaccines (e.g., mRNA-1283) can reduce the transmission by creating immunity in the population, thus lowering the incidence and spread of these diseases...In addition, the authors discuss crucial advances in the growth of mRNA-based vaccines to date; which dominate an extensive scope of therapeutic implementation. Finally, recent mRNA-based vaccines in clinical trials, adjuvant benefits, and prospects are discussed."

Journal • Review • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of mRNA-1283 Compared with mRNA-1273 in Participants ≥12 Years of Age to Prevent COVID-19 (clinicaltrialsregister.eu) - P3 | N=33574 | Sponsor: ModernaTX, Inc.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (clinicaltrials.gov) - P2 | N=540 | Completed | Sponsor: ModernaTX, Inc. | Phase classification: P2a ➔ P2

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

Domain-based mRNA vaccines encoding spike protein N-terminal and receptor binding domains confer protection against SARS-CoV-2. (PubMed, Sci Transl Med) - P2a | "K18-hACE2 mice immunized with mRNA-1283 or mRNA-1273 as a primary series demonstrated similar degrees of protection from challenge with SARS-CoV-2 Delta and Omicron variants at all vaccine dosages. These results support clinical assessment of mRNA-1283, which has now entered clinical trials (NCT05137236)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P1 | N=104 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. (PubMed, Hum Vaccin Immunother) - P1 | "At day 57, all dose levels of the 2-dose mRNA-1283 regimen (including the lowest dose level [10 µg]) induced robust nAb and bAb responses that were comparable to those of mRNA-1273 (100 µg). mRNA-1283 was generally safe in adults, with all dose levels of the 2-dose regimen (10, 30, and 100 µg) eliciting similar immunogenicity as the 2-dose mRNA-1273 regimen (100 µg).Clinical Trials Registration: Clinicaltrials.gov, NCT04813796."

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

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (clinicaltrials.gov) - P2a | N=543 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P1 | N=104 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Apr 2023 ➔ Sep 2023 | Trial primary completion date: Apr 2023 ➔ Sep 2023

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

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (clinicaltrials.gov) - P2a | N=560 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting | N=420 ➔ 560

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

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P1; N=106; Active, not recruiting; Sponsor: ModernaTX, Inc.; Trial completion date: Apr 2022 ➔ Apr 2023; Trial primary completion date: Apr 2022 ➔ Apr 2023

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

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (clinicaltrials.gov) - P2a; N=420; Recruiting; Sponsor: ModernaTX, Inc.; Not yet recruiting ➔ Recruiting

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

"circle, circle, dot, dot, 100mcg mRNA-1283" (@thePaulChurch)

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters (clinicaltrials.gov) - P2a; N=420; Not yet recruiting; Sponsor: ModernaTX, Inc.

Clinical • New P2a trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 (clinicaltrials.gov) - P1; N=106; Active, not recruiting; Sponsor: ModernaTX, Inc.; Recruiting ➔ Active, not recruiting

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

A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccines in Healthy Adults Between 18 Years and 55 Years of Age (clinicaltrials.gov) - P1; N=125; Recruiting; Sponsor: ModernaTX, Inc.

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

Moderna Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides Business Updates (Businesswire) - P3, N=30,000; COVE (NCT04470427); Sponsor: ModernaTX, Inc.; "Phase 2/3 study of mRNA-1273 in adolescents has completed enrollment of 3,000 participants....Today, the Company is sharing an update on the Phase 3 COVE study. An updated total of adjudicated COVID-19 cases among baseline seronegative participants in the COVE study starting two weeks following the second dose showed 690 cases to date, of which 639 cases of COVID-19 were observed in the placebo group versus 51 cases observed in the Moderna COVID-19 Vaccine group....Phase 2 'KidCOVE' study of mRNA-1273 in young children: The Phase 2 study of mRNA-1273 in pediatric population ages 6 months to 11 years will start in the near-term....mRNA-1283 is a next-generation vaccine candidate against COVID-19...The encoded mRNA-1283 antigen is shorter than mRNA-1273, and is being developed as a potential refrigerator stable mRNA vaccine..."

Enrollment closed • New molecule • New P2 trial • P2/3 data • Infectious Disease • Novel Coronavirus Disease

First Participants Dosed in Phase 1 Study Evaluating mRNA-1283, Moderna’s Next Generation COVID-19 Vaccine (Businesswire) - "...the first participants have been dosed in the Phase 1 study of mRNA-1283, the Company’s next generation COVID-19 vaccine candidate....This Phase 1 dose-ranging study will assess the safety and immunogenicity of mRNA-1283...This Phase 1 study will evaluate three dose levels, 10 µg, 30 µg, and 100 µg, of the mRNA-1283 vaccine candidate given to healthy adults as a 2-dose series, 28 days apart, and one dose level, 100 µg, of mRNA-1283 given to healthy adults in a single dose. These will be compared with a 2-dose series of 100 µg of mRNA-1273, the currently authorized dose level."

Trial status • Infectious Disease • Novel Coronavirus Disease

"@KizzyPhD Hi Doc! Is the mRNA 1283 different than 1273.351?" (@ScottyWitte)