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

Respiratory Syncytial Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143046
• Other study ID #: mRNA-1345-P201
• Secondary ID: 2023-505359-37-0
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2023
• Est. completion date: February 18, 2026

Study information

• Verified date: May 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: February 18, 2026
• Est. primary completion date: February 18, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 engaged with local antenatal care and will 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.

Specific inclusion criteria for Japanese pregnant women:

• Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Virus Diseases

Intervention

Biological:
• mRNA-1345
Sterile liquid for injection
• Placebo
0.9% sodium chloride (normal saline) injection

Locations

Country	Name	City	State
Canada	Dalhousie University - 5820 University Ave	Halifax	Nova Scotia
Canada	Sainte Justine Hospital	Montréal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Ottawa Hospital Civic Campus	Ottawa	Ontario
Canada	Centre Hospitalier de l'Université Laval	Quebec
Chile	Clínica Universidad de los Andes	Las Condes	Región-MetropolitanadeSantiago
Chile	Centro Internacional de Estudios Clínicos	Recoleta	Región-MetropolitanadeSantiago
Chile	Red Hospital Clinico de la Universidad de Chile	Santiago
Denmark	Aarhus Universitetshospital	Aarhus	Central Jutland
Denmark	Regionshospitalet Gødstrup	Herning	Central Jutland
Denmark	Hvidovre Hospital	Hvidovre	Capital
Japan	Shonan Kamakura General Hospital	Kamakura-Shi	Kanagawa
Japan	Saitama City Hospital	Saitama-Shi	Saitama
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-Ku	Tokyo
Japan	Saiseikai Yokohamashi Nanbu Hospital	Yokohama	Kanagawa
Panama	Centro De Vacunacion Internacional, S.A. (Cevaxin)	Ciudad De Panamá
Panama	Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera	Ciudad De Panamá
Panama	Centro De Vacunacion Internacional, S.A. (Cevaxin) - David	David	Chiriquí
Panama	CEVAXIN 24 de diciembre	Panamá
Panama	Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama	Pueblo Nuevo
South Africa	Josha Research	Bloemfontein	Free State
South Africa	FAM-CRU	Cape Town	Western Cape
South Africa	Bothe ke Bontle Health Services-316 Kuit st	Pretoria	Gauteng
South Africa	Setshaba Research Centre	Soshanguve	Gauteng
South Africa	WITS Clinical Research Site - PPDS	Soweto	Gauteng
South Africa	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset
United Kingdom	Cardiff & Vale University Health Board-PPDS	Cardiff	South Glamorgan
United Kingdom	Glasgow Clinical Research Facility - PPDS	Glasgow
United Kingdom	St George's Hospital	London	Surrey
United Kingdom	The Royal Free Hospital	London	Middlesex
United Kingdom	The Royal London Hospital	London	London, City Of
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United States	DM Clinical Research - Birthing Center of New York - ERN - PPDS	Brooklyn	New York
United States	Velocity Clinical Research - Covington - PPDS	Covington	Louisiana
United States	SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS	Dothan	Alabama
United States	Matrix Clinical Research - Gardena	Gardena	California
United States	Velocity Clinical Research (Grand Island - Nebraska) - PPDS	Grand Island	Nebraska
United States	Boeson Research GTF - Great Falls - ERN - PPDS	Great Falls	Montana
United States	Velocity Clinical Research (Hastings - Nebraska) - PPDS	Hastings	Nebraska
United States	DM Clinical Research - Bellaire - ERN - PPDS	Houston	Texas
United States	Matrix Clinical Research - Huntington Park	Huntington Park	California
United States	Clinical Research Prime - ClinEdge - PPDS	Idaho Falls	Idaho
United States	Boeson Research KAL - Kalispell - ERN - PPDS	Kalispell	Montana
United States	Maximos OB/GYN	League City	Texas
United States	Applied Research Center of Arkansas - ClinEdge - PPDS	Little Rock	Arkansas
United States	Matrix Clinical Research, Inc - Corporate Office	Los Angeles	California
United States	Boeson Research MSO - Missoula - ERN - PPDS	Missoula	Montana
United States	Velocity Clinical Research (Norfolk - Nebraska) - PPDS	Norfolk	Nebraska
United States	Abby's Research Institute	Phoenix	Arizona
United States	Clinical Research Prime - ClinEdge - Rexburg - PPDS	Rexburg	Idaho
United States	Saginaw Valley Medical Research Group LLC	Saginaw	Michigan
United States	Maternal Fetal Diagnostics Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Denmark,  Japan,  Panama,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 7 (7 days post vaccination)
Primary	Number of Maternal Participants with Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days post vaccination)
Primary	Number of Maternal Participants with Medically-Attended AEs (MAAEs)		Day 1 to Month 6 (6 months postdelivery)
Primary	Number of Maternal Participants with Adverse Events of Special Interest (AESIs)		Day 1 to Month 12 (12 months postdelivery)
Primary	Number of Maternal Participants with Serious Adverse Events (SAEs)		Day 1 to Month 12 (12 months postdelivery)
Primary	Number of Maternal Participants with AEs Leading to Discontinuation		Day 1 to Month 12 (12 months postdelivery)
Primary	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)
Primary	Number of Infant Participants with MAAEs		Day 1 (birth) to Month 12
Primary	Number of Infant Participants with AESIs		Day 1 (birth) to Month 12
Primary	Number of Infant Participants with SAEs		Day 1 (birth) to Month 12
Primary	Number of Infant Participants With Birth Outcomes	Birth outcomes will include gestational age and anthropometric measurements.	Day 1 (birth) to Month 12
Secondary	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)
Secondary	Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants		Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Secondary	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)
Secondary	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)
Secondary	GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants		Day 1 (birth), and Months 2, 6, and 12
Secondary	GMC of Serum RSV-F Binding Antibodies in Infant Participants		Day 1 (birth), and Months 2, 6, and 12