Slide 1: Safety and Immunogenicity of mRNA-1647, an mRNA-Based Cytomegalovirus Vaccine in Healthy Adults
Safety and Immunogenicity of mRNA- 1647, an mRNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results of a Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial Presenter: Sandeep Basnet Presented at IDWeek October 14, 2023 Boston, Massachusetts, USA © 2023 M oderna, Inc. C
Slide 2: Authors, Disclosures, and Acknowledgments
Authors, Disclosures, and Acknowledgments • Authors – Lori Panther,1 Sandeep Basnet,1 Carlos Fierro,2 Daniel Brune,3 Richard Leggett,4 James Peterson,5 Paul Pickrell,6 Jiang Lin,1 Kai Wu,1 Heather Lee,1 Roxane Hasselbeck,1 Andrew Natenshon,1 Jacqueline Miller1 • Affiliations: 1Moderna, Inc., Cambrid
Slide 3: Forward-Looking Statements
Forward-Looking Statements • This present ation cont ains forward-looking st atements within the meaning of t he Privat e Securit ies Lit igation Reform Act of 1995, as amended. In some cases, forward-looking st atements can be ident ified by t erminology such as “will,” “may,” “should,” “expect s,”
Slide 4: mRNA-1647: mRNA-Based Investigational CMV Vaccine
mRNA-1647: mRNA-Based Investigational CMV Vaccine • CMV is a widespread latent virus which is the leading infectious cause of birth defects globally and a substantial cause of morbidity in immunocompromised individuals 1,2 – There are no approved CMV vaccines available, and a safe and effective meth
Slide 5: Phase 2 Study of mRNA-1647 in Healthy Adults (NCT04232280)
Phase 2 Study of mRNA-1647 in Healthy Adults (NCT04232280) This phase 2, randomized, placebo-controlled, observer-blind, dose-finding trial evaluated the safety and immunogenicity of mRNA-1647 in healthy CMV-seronegative and CMV-seropositive US adults aged 18-40 years Safety Endpoints CMV-Seronegati
Slide 6: Participant Disposition
Participant Disposition CMV-Seronegative Participants Placebo mRNA-1647 50 µg 100 µg 150 µg Randomized (n = 55) Randomized Randomized Randomized (n = 45) (n = 73) (n = 45) Discontinued Discontinued Discontinued Discontinued Receiv ed dose 1 (n = 11) (n = 21) (n = 10) (n = 8) Receiv ed dose 1 Receiv
Slide 7: Most Common Solicited Local Adverse Reactions by CMV Serostatus
Most Common Solicited Local Adverse Reactions by CMV Serostatus CMV-Seronegative Participants (n = 218) CMV-Seropositive Participants (n = 97) Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3 Any Local AR Pain Participants (%) Participants (%) Any* Grade 3 A = Placebo; B = mRNA-1647 50 µg; C = mRNA-1647 10
Slide 8: Most Common Solicited Systemic Adverse Reactions by CMV Serostatus
Most Common Solicited Systemic Adverse Reactions by CMV Serostatus CMV-Seronegative Participants (n = 218) CMV-Seropositive Participants (n = 97) Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3 Any Systemic AR Headache Fatigue Participants (%) Participants (%) Any* Grade 3 A = Placebo; B = mRNA-1647 50 µg
Slide 9: Unsolicited Adverse Events
Unsolicited Adverse Events CMV-Seronegative CMV-Seropositive mRNA-1647 mRNA-1647 Placebo Placebo (n = 53) 50 µg 100 µg 150 µg Total (n = 27) 50 µg 100 µg 150 µg Total n (%) (n = 45) (n = 72) (n = 45) (n = 162) n (%) (n = 18) (n = 37) (n = 18) (n = 73) n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%)
Slide 10: Antibody-Mediated Immunogenicity by CMV Serostatus: Neutralizing Antibodies
Antibody-Mediated Immunogenicity by CMV Serostatus: Neutralizing Antibodies nAbs Against Epithelial Cell Infection nAbs Against Fibroblast Infection • CMV-seronegative: nAbs against epithelial cell infection increased • CMV-seronegative: nAbs against fibroblast infection increased after mRNA-1647 do
Slide 11: Antibody-Mediated Immunogenicity by CMV Serostatus: Binding Antibodies
Antibody-Mediated Immunogenicity by CMV Serostatus: Binding Antibodies Anti-Pentamer bAbs Anti-gB bAbs • CMV-seronegative: anti-pentamer bAbs increased after mRNA- • CMV-seronegative: anti-gB bAbs increased after mRNA-1647 dose 2 1647 dose 1 and increased further after dose 3 but remained below the
Slide 12: Cell-Mediated Immunogenicity by CMV Serostatus
Cell-Mediated Immunogenicity by CMV Serostatus Non-Naive CD4+ Th1 Cells - gB (%) CMV-Seronegative Participants n 3 0 6 4 5 2 6 4 4 2 7 4 3 2 6 3 3 2 7 2 4 2 6 1 4 2 7 2 4 2 5 2 CMV-Seronegative Placebo mRNA-1647 50 µg mRNA-1647 100 µg mRNA-1647 150 µg CMV-Seropositive Participants n 2 2 5 3 3 2 5 4
Slide 13: Conclusions
Conclusions • This analysis presents the safety and immunogenicity findings from the phase 2 clinical trial of mRNA -1647 in CMV-seronegative and CMV-seropositiv e healthy adults 18-40 years of age • mRNA-1647 was generally well-tolerated at all dose lev els assessed (50 µg, 100 µg,150 µg) regardles
Slide 14: Thank you
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