mRNA-1283 / Moderna - LARVOL DELTA

Real-World Co-administration Patterns of mRNA-1283 COVID-19 Vaccine with Influenza and Other Vaccines in the United States (IDWeek 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease • Influenza • Novel Coronavirus Disease

Effectiveness of 2025-2026 mRNA-1283 and BNT162b2 COVID-19 vaccines against COVID-19–related hospitalizations and medically attended COVID-19 among adults aged ≥ 65 years in the United States (IDWeek 2026) - No abstract available

Clinical • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P2 trial • Infectious Disease • 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 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed | Phase classification: P3/4 ➔ P4

Phase classification • Trial completion • Infectious Disease • Novel Coronavirus Disease

Interim Effectiveness of 2025-2026 mRNA-1283 and BNT162b2 COVID-19 Vaccines Against COVID-19-Related Outcomes Among Adults Aged ≥ 65 Years in the United States. (PubMed, Infect Dis Ther) - "This study provides the first real-world evidence that mRNA-1283 was associated with protection against COVID-19-related hospitalization and medically attended COVID-19 among vulnerable older adults at highest risk of severe disease. These findings support mRNA-1283 as an important public health tool for reducing the continual burden of COVID-19 in this population."

Journal • Infectious Disease • Novel Coronavirus Disease

Cell-Mediated Immunity of mRNA-1283 Vaccine Encoding SARS-CoV-2 Spike Receptor-Binding and N-Terminal Domains in Preclinical and Clinical Studies. (PubMed, J Infect Dis) - P2 | "In preclinical and clinical studies, mRNA-1283 induced T-cell responses similar to mRNA-1273."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

Immune correlates analysis in NextCOVE trial for a next-generation mRNA-1283 COVID-19 vaccine. (PubMed, Hum Vaccin Immunother) - P3 | "In the Phase 3 NextCOVE trial (NCT05815498), which enrolled more than 10,000 participants aged ≥12 y, mRNA-1283 (10 µg; bivalent ancestral plus Omicron BA.4/BA.5) met the non-inferiority criterion for relative vaccine efficacy (rVE) versus mRNA-1273 (50 µg; bivalent) and elicited higher nAb responses. The estimated hazard ratios per 10-fold increase in Day 29 nAbs against D614G, BA.4/BA.5, and XBB.1.5 were 0.70 (95% confidence interval [CI]: 0.48-1.02; p = .064), 0.49 (95% CI: 0.41-0.58; p < .001), and 0.41 (95% CI: 0.35-0.49; p < .001), respectively. These findings indicate that nAb levels, particularly against variants antigenically similar to circulating strains, remain associated with stronger contemporaneous protection against COVID-19."

Clinical • Journal • Infectious Disease • 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. | Phase classification: P3/4 ➔ P4

Phase classification • Infectious Disease • Novel Coronavirus Disease

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

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

Potential Public Health and Economic Impact of the Next-Generation COVID-19 Vaccine mRNA-1283 in The Netherlands. (PubMed, Vaccines (Basel)) - "The results support continued COVID-19 vaccination to mitigate the ongoing health and societal burden of SARS-CoV-2 in the Netherlands. The comparative analyses indicate that mRNA-1283 may be associated with substantial health benefits over originally licensed mRNA vaccines; consequently, its use may further improve health outcomes and economic efficiency within COVID-19 vaccination programs."

HEOR • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Reactogenicity (clinicaltrials.gov) - P4 | N=1000 | Active, not recruiting | Sponsor: Marcel Curlin | Trial completion date: Jun 2028 ➔ Jun 2026 | Trial primary completion date: Apr 2027 ➔ Jun 2026 | Not yet recruiting ➔ Active, not recruiting

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

Modeling the cost-effectiveness of the next-generation COVID-19 mRNA-1283 vaccine in the United States. (PubMed, J Med Econ) - "mRNA-1283 was compared with no annual vaccination and originally licensed mRNA vaccines mRNA-1273 and BNT162b2. Based on rVE assumptions made, mRNA-1283 was estimated to dominate originally-licensed mRNA vaccines in this recommended population. mRNA-1283 may provide a valuable option to optimize US COVID-19 immunization programs and protect those most vulnerable."

HEOR • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Preventing COVID-19 in at-risk populations: moving towards next-generation mRNA-1283 COVID-19 vaccine to address current challenges. (PubMed, Expert Rev Vaccines) - "While the original mRNA COVID-19 vaccine, mRNA-1273, targets the full-length SARS-CoV-2 spike protein, mRNA-1283 is a novel next-generation mRNA COVID-19 vaccine that specifically targets immunodominant domains within the spike protein. Initial modeling studies indicate that mRNA-1283 could prevent more hospitalizations than current COVID-19 vaccines. Evidence to date suggests that the novel next-generation mRNA-1283 vaccine holds promise to advance progress in reducing the ongoing burden of COVID-19 across vulnerable populations."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Potent and dose-sparing next-generation SARS-CoV-2 vaccine, mRNA-1283, induces polyfunctional and durable T cell immunity. (PubMed, NPJ Vaccines) - P1 | "TCRβ sequencing demonstrated significant increases in the breadth and frequency of SARS-CoV-2-associated TCRs, which correlated with functional spike-specific T cell responses. Therefore, the low-dose (10 µg) regimen of the next-generation COVID-19 vaccine, mRNA-1283, induces polyfunctional and durable CD4+ and CD8+ T cell immunity comparable to the standard 100 µg mRNA-1273 vaccine, supporting a dose-sparing strategy without compromising long-term cellular protection against severe COVID-19."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • TRB

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 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

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

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