Moderna : ISIRV 2025 (RSV twelve-month revaccination)

Published: 2025-03-14 18:36:11 ET MRNA

Safety, Tolerability, and Immunogenicity of Revaccination with mRNA-1345, a Vaccine Against RSV, Given at 12 Months Following a Primary Dose in Adults ≥50 Years

Jaya Goswami, Jose F. Cardona, Denise C. Hsu, Alana K. Simorellis, Lauren Wilson, Rakesh Dhar, Xiaowei Wang, Archana Kapoor, Avi Collins, Vinicius Righi, Lan Lan, Jiejun Du, Honghong Zhou, Sonia K. Stoszek, Christine A. Shaw, Caroline Reuter, Eleanor Wilson, Jacqueline M. Miller, Rituparna Das

March 13, 2025

Presented at the 13th International RSV Symposium (RSV2025); March 12-15, 2025; Iguazu Falls, Brazil

Disclosures and Acknowledgments

RSV Vaccination and mRNA-1345

mRNA-1345 is an mRNA-based,

LNP-encapsulated RSV vaccine encoding membrane-anchoredRSV F glycoprotein in the prefusion conformation

CDC, Centers for Disease Control and Prevention; LNP, lipid nanoparticle; LRTD, lower respiratory tract disease; RSV, respiratory syncytial virus.

1. Savic M, et al. Influenza Other Respir Viruses. 2023;17(1):e13031. 2. Shi T, et al. J Infect Dis. 2020;222(suppl 7):S577-S583. 3. Moderna, Inc., Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA. Accessed January 10,2025. https://news.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx. 4. Moderna, Inc., Moderna Receives European Commission Approval for RSV Vaccine mRESVIA. Accessed January 10, 2025. https://s29.q4cdn.com/435878511/files/doc_news/Moderna-Receives-European-Commission-Approval-for-RSV-Vaccine-mRESVIAR-2024.pdf. 5. mRESVIA Prescribing Information. Accessed January 10, 2025. https://www.fda.gov/media/179005/download?attachment. 6. Moderna, Inc., Moderna Receives Health Canada Approval for RSV Vaccine for Adults Aged 60 Years and Older. Accessed January 10, 2025. https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-Health-Canada-Approval-for-RSV-Vaccine-for-Adults-Aged-60-Years-and-Older/default.aspx. 7. Center for Disease Control and Prevention. Respiratory Syncytial Virus (RSV) Immunizations. Accessed January 10, 2025. https://www.cdc.gov/vaccines/vpd/rsv/index.html. 8. Vashishtha V, et al. Expert Rev Vaccines. 2024; 23(1):389-408. 9. Shaw C, et al. J Infect Dis. 2024;230(3)e647-e656.

Study Schema

Phase 3, Multi-Part, Single-Arm, Open-Label Study in Adults Aged ≥50 Years (NCT05330975)

Primary Dose (Part B)1

Day 1

254

RSV Vaccine

Placebo

(mRNA-1345)

289

RSV Vaccine

COVID-19

Bivalent

(mRNA-1345)

Vaccine

Revaccination (Part C)

12-15 Months

RSV Vaccine (mRNA-1345)

(n = 543)

Participants from Part B of the study were enrolled into Part C and revaccinated with mRNA-1345

RSV, respiratory syncytial virus.

ClinicalTrials.gov. NCT05330975. https://clinicaltrials.gov/study/NCT05330975.

Data cutoff for the interim revaccination analysis was December 4, 2023.

1. Goswami J, et al. Lancet Infect Dis. 2024:S1473-3099(24)00589-9.

Study Objectives, Endpoints, and Noninferiority Success Criteria

Safety Endpoints

Primary Endpoints

Immunogenicity Endpoints

Primary Endpoints

Key Secondary Endpoints

Success Criteria for Noninferiority of Immune Response at Day 29

Ab, antibody; AE, adverse event; AR, adverse reaction; CI, confidence interval; GMR, geometric mean ratio; GMT, geometric mean titer; nAb, neutralizing antibody; LLOQ, lower limit of

quantification; MAAE, medically attended adverse event; RSV, respiratory syncytial virus; SAE, serious adverse event .

aSeroresponse defined as ≥4x LLOQ if nAb titers at baseline were

Demographics and Baseline Characteristics

Safety Set

mRNA-1345 50 µg Revaccination

(n = 543)

Age, years

Median (Min, Max)

62.0 (50, 91)

Age group 2, n (%)

50-59 years

210 (38.7)

≥60 years

333 (61.3)

Sex, n (%)

Female

313 (57.6)

Race, n (%)

White

412 (75.9)

Black/African American

107 (19.7)

Asian

7 (1.3)

Ethnicity, n (%)

Hispanic or Latino

254 (46.8)

The baseline value was defined as the most recent non-missing measurement (scheduled or unscheduled) collected on or before the first injection date of the primary dose in an earlier part of the trial.

Age groups were derived based on the age provided by the investigators on the case report form.

At the interim analysis, participants were revaccinated at a median interval of 12.6 months post-primary vaccination.

Safety

Solicited Adverse Reactions Within 7 Days After Revaccination

Solicited Safety Set

Local

Systemic

Grade 1

Grade 2

Grade 3

There were no local or systemic grade 4 events.

Safety Events of Interest

AE, adverse event; AESI, adverse event of special interest.

Immunogenicity

Disclaimer

Moderna Inc. published this content on March 13, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 14, 2025 at 22:35:04.343.