A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity in Infants Born to Vaccinated Mothers

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus
• Intervention / Treatment: Biological: Placebo; Biological: mRNA-1345

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Moderna Clinical Trials Support Center; Phone Number: 1-877-777-7187; Email: clinicaltrials@modernatx.com

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Not yet recruiting
    • Centre Hospitalier de l'Universite Laval
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1
      • Not yet recruiting
      • Dalhousie University - 5820 University Ave
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Not yet recruiting
      • Ottawa Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • Not yet recruiting
      • Ottawa Hospital Civic Campus
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Not yet recruiting
      • Sainte Justine Hospital
• Chile
  • Santiago, Chile, 8380453
    • Not yet recruiting
    • Red Hospital Clinico de la Universidad de Chile
  • Región-MetropolitanadeSantiago
    • Las Condes, Región-MetropolitanadeSantiago, Chile, 7550000
      • Not yet recruiting
      • Clinica Universidad de Los Andes
    • Recoleta, Región-MetropolitanadeSantiago, Chile, 8420000
      • Not yet recruiting
      • Centro Internacional de Estudios Clinicos
• Denmark
  • Capital
    • Hvidovre, Capital, Denmark, DK-2650
      • Not yet recruiting
      • Hvidovre Hospital
  • Central Jutland
    • Aarhus, Central Jutland, Denmark, 8200
      • Not yet recruiting
      • Aarhus Universitetshospital
    • Herning, Central Jutland, Denmark, 7400
      • Not yet recruiting
      • Regionshospitalet Gødstrup
• Japan
  • Kanagawa
    • Kamakura-Shi, Kanagawa, Japan, 247-8533
      • Not yet recruiting
      • Shonan Kamakura General Hospital
    • Yokohama, Kanagawa, Japan, 234-0054
      • Not yet recruiting
      • Saiseikai Yokohamashi Nanbu Hospital
  • Saitama
    • Saitama-Shi, Saitama, Japan, 336-0911
      • Not yet recruiting
      • Saitama City Hospital
  • Tokyo
    • Shinjuku-Ku, Tokyo, Japan, 162-8655
      • Not yet recruiting
      • Center Hospital of the National Center for Global Health and Medicine
• Panama
  • Ciudad De Panamá, Panama
    • Not yet recruiting
    • Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
  • Ciudad De Panamá, Panama
    • Not yet recruiting
    • Centro De Vacunacion Internacional, S.A. (Cevaxin)
  • Panamá, Panama
    • Not yet recruiting
    • Cevaxin 24 de diciembre
  • Pueblo Nuevo, Panama
    • Not yet recruiting
    • Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama
  • Chiriquí
    • David, Chiriquí, Panama
      • Not yet recruiting
      • Centro De Vacunacion Internacional, S.A. (Cevaxin) - David
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9300
      • Not yet recruiting
      • Josha Research
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0184
      • Not yet recruiting
      • Bothe ke Bontle Health Services-316 Kuit st
    • Soshanguve, Gauteng, South Africa, 152
      • Not yet recruiting
      • Setshaba Research Centre
    • Soweto, Gauteng, South Africa, 2013
      • Not yet recruiting
      • WITS Clinical Research Site - PPDS
  • Limpopo
    • Thabazimbi, Limpopo, South Africa, 387
      • Not yet recruiting
      • Limpopo Clinical Research Initiative
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7505
      • Not yet recruiting
      • FAM-CRU
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Not yet recruiting
    • Glasgow Clinical Research Facility - PPDS
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Not yet recruiting
      • Royal Bournemouth Hospital
  • Hampshire
    • Southampton, Hampshire, United Kingdom
      • Not yet recruiting
      • Southampton General Hospital
  • London, City Of
    • London, London, City Of, United Kingdom, E1 1FR
      • Not yet recruiting
      • The Royal London Hospital
  • Middlesex
    • London, Middlesex, United Kingdom, NW3 2QG
      • Not yet recruiting
      • The Royal Free Hospital
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 4XN
      • Not yet recruiting
      • Cardiff & Vale University Health Board-PPDS
  • Surrey
    • London, Surrey, United Kingdom, SW17 0QT
      • Not yet recruiting
      • St George's Hospital
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305-7376
      • Recruiting
      • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
  • Arizona
    • Phoenix, Arizona, United States, 85031-3878
      • Not yet recruiting
      • Abby's Research institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72212-4169
      • Recruiting
      • Applied Research Center of Arkansas - Clinedge - PPDS
  • California
    • Gardena, California, United States, 90247-4956
      • Recruiting
      • Matrix Clinical Research - Gardena
    • Huntington Park, California, United States, 90255-2913
      • Recruiting
      • Matrix Clinical Research - Huntington Park
    • Los Angeles, California, United States, 90057-4103
      • Recruiting
      • Matrix Clinical Research, Inc - Corporate Office
  • Idaho
    • Idaho Falls, Idaho, United States, 83404-5305
      • Recruiting
      • Clinical Research Prime - ClinEdge - PPDS
    • Rexburg, Idaho, United States, 83440-5390
      • Recruiting
      • Clinical Research Prime - ClinEdge - Rexburg - PPDS
  • Louisiana
    • Covington, Louisiana, United States, 70433-7237
      • Recruiting
      • Velocity Clinical Research - Covington - PPDS
  • Michigan
    • Saginaw, Michigan, United States, 48604-9533
      • Recruiting
      • Saginaw Valley Medical Research Group LLC
  • Montana
    • Great Falls, Montana, United States, 59405-5316
      • Recruiting
      • Boeson Research GTF - Great Falls - ERN - PPDS
    • Kalispell, Montana, United States, 59901-2158
      • Recruiting
      • Boeson Research KAL - Kalispell - ERN - PPDS
    • Missoula, Montana, United States, 59804-7401
      • Recruiting
      • Boeson Research MSO - Missoula - ERN - PPDS
  • Nebraska
    • Grand Island, Nebraska, United States, 68803-4327
      • Recruiting
      • Velocity Clinical Research (Grand Island - Nebraska) - PPDS
    • Hastings, Nebraska, United States, 68901-2615
      • Recruiting
      • Velocity Clinical Research (Hastings - Nebraska) - PPDS
    • Norfolk, Nebraska, United States, 68701-7701
      • Recruiting
      • Velocity Clinical Research (Norfolk - Nebraska) - PPDS
  • New York
    • Brooklyn, New York, United States, 11220-5203
      • Not yet recruiting
      • DM Clinical Research - Birthing Center of New York - ERN - PPDS
  • Texas
    • Houston, Texas, United States, 77081
      • Not yet recruiting
      • DM Clinical Research - Bellaire - ERN - PPDS
    • League City, Texas, United States, 77573-2681
      • Recruiting
      • Maximos Ob/Gyn
  • Utah
    • Salt Lake City, Utah, United States, 84132-0001
      • Not yet recruiting
      • Maternal Fetal Diagnostics Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

Maternal Participants

• Are adults ≥18 years to <40 years of age inclusive, at the time of signing the informed consent.
• Will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report).
• Intend to deliver at a maternity unit where study procedures can be performed.
• Are willing and able to attend all study visits, to undergo all study procedures/or have their infant undergo all study procedures, and to comply with study requirements, including a means of communication (for example, phone, text message or email) with study site staff.
• Have received local standard of antenatal care prior to enrollment and expect to continue to do so through the remainder of their pregnancy.
• Have had an antenatal obstetric ultrasound at ≥18 weeks of pregnancy or be willing to have an antenatal obstetric ultrasound at Screening if not already conducted.

Infant Participants

• Have consent from infant participant's parent(s)/legally authorized representative (LAR) if required by local regulations.

Key Exclusion Criteria:

Maternal Participants

• Acutely ill or febrile (temperature ≥38.0 degrees Celsius [℃]/100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
• Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Have conditions in the current pregnancy or in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
• Received or plans to receive any mRNA vaccine or COVID-19 vaccine within 4 weeks before or after Day 1 and/or any other nonstudy vaccine within 2 weeks before or after Day 1.
• Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.

Infant Participants

• Is a child who has been placed under the control or protection of an agency, organization, institution, or entity by the courts, the government, or a government body acting in accordance with powers conferred on them by laws and regulation (for example, foster care). This does not include a child who is adopted or has an appointed LAR.

Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1345 Dose A; Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.	Biological: mRNA-1345; Sterile liquid for injection
Experimental: mRNA-1345 Dose B; Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B.	Biological: mRNA-1345; Sterile liquid for injection
Experimental: mRNA-1345 Dose C; Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.	Biological: mRNA-1345; Sterile liquid for injection
Placebo Comparator: Placebo; Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 7 (7 days post vaccination)
Number of Maternal Participants with Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)		Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)		Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)		Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation		Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes	Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.	Day 1 to Month 12 (12 months postdelivery)
Number of Infant Participants with MAAEs		Day 1 (birth) to Month 12
Number of Infant Participants with AESIs		Day 1 (birth) to Month 12
Number of Infant Participants with SAEs		Day 1 (birth) to Month 12
Number of Infant Participants With Birth Outcomes	Birth outcomes will include gestational age and anthropometric measurements.	Day 1 (birth) to Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants	Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants	Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants	Day 29, delivery, and Month 6 (6 months postdelivery)
Percentage of Maternal Participants With ≥4-fold Increase From Baseline in Neutralizing Antibody Titers and Binding Antibody Concentrations	Baseline up to Month 6 (6 months postdelivery)
GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants	Day 1 (birth), and Months 2, 6, and 12
GMC of Serum RSV-F Binding Antibodies in Infant Participants	Day 1 (birth), and Months 2, 6, and 12

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): February 18, 2026
• Study Completion (Estimated): February 18, 2026

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Moderna; Messenger RNA; Viral Diseases; mRNA-1345; RSV vaccine
• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: mRNA-1345-P201; 2023-505359-37-00 (Other Identifier: EU CT number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No