mRNA-1283 / Moderna - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without High-Risk Conditions for Severe Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P4 | N=30000 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P4 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and safety of a SARS-CoV-2 N-terminal domain and receptor-binding domain monovalent XBB.1.5 vaccine in Japanese participants. (PubMed, Vaccine) - "mRNA-1283.815 elicited noninferior neutralizing antibody responses to mRNA-1273.815 against Omicron XBB.1.5 at Day 29, meeting the primary immunogenicity objective, with the GMR indicating higher responses of mRNA-1283.815 vs mRNA-1273.815 (GMR [95 % CI], 1.195 [1.028-1.389]). These results support the effectiveness of a monovalent formulation of mRNA-1283."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Projected Public Health Impact of Synchronized COVID-19 and Influenza Vaccination With a Combination Vaccine in US Older Adults (ISPOR-EU 2025) - "The base case reflected observed, asynchronous vaccine coverage rates (VCRs) and used CDC-derived influenza vaccine effectiveness (VE) and real-world VE data for the mRNA-1273 COVID-19 vaccine...Scenario 2: Scenario 1 plus improved VE reflecting next-generation COVID-19 vaccines (e.g., mRNA-1283)... A synchronized COVID-19 and influenza vaccination campaign could significantly reduce COVID-19 hospitalizations. Combination vaccines incorporating next generation vaccines may further amplify this benefit via improved efficacy and driving uptake."

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations (clinicaltrials.gov) - P4 | N=832 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting | N=260 ➔ 832 | Trial completion date: Sep 2025 ➔ May 2026 | Trial primary completion date: Sep 2025 ➔ May 2026

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

The Next-Generation mRNA-1283 COVID-19 Vaccine Elicits Similar and Durable Cellular Immune Responses Compared With mRNA-1273 (IDWeek 2025) - No abstract available

Infectious Disease • Novel Coronavirus Disease

Potential Impact of the Next-Generation COVID-19 mRNA-1283 Vaccine on Post-acute Outcomes of COVID-19 (IDWeek 2025) - No abstract available

Infectious Disease • Novel Coronavirus Disease

Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial. (PubMed, Lancet Infect Dis) - P3 | "mRNA-1283 was well-tolerated. The rVE and immunogenicity non-inferiority criteria were met, with higher antibody responses for mRNA-1283 versus mRNA-1273. The potential clinical benefit of mRNA-1283 versus mRNA-1273 needs to be confirmed in post-marketing evaluation."

Journal • P3 data • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

The potential impact of the next-generation COVID-19 mRNA-1283 vaccine in Canada. (PubMed, J Med Econ) - "This study estimated the public health impact and economically justifiable price (EJP) of Moderna's next-generation COVID-19 vaccine (mRNA-1283) versus no vaccination in Canada, and relative to currently authorized vaccines (mRNA-1273; BNT-162b2). British and American estimates were used as Canadian data proxies. mRNA-1283 could reduce the COVID-19 clinical burden and provide economic value for the NACI-recommended population, exceeding current mRNA vaccines; COVID-19 program planners may consider supporting access to mRNA-1283 to optimize public health impact."

Journal • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations (clinicaltrials.gov) - P4 | N=260 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations (clinicaltrials.gov) - P4 | N=260 | Recruiting | Sponsor: ModernaTX, Inc.

New P4 trial • 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

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

A response to: A letter to the editor in response to: 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) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

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 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A letter to the editor in response to: 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) - No abstract available

Journal • 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