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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06143046

Collaborator

(none)

360

Enrollment

Locations

Arms

27.1

Anticipated Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus	Biological: mRNA-1345 Biological: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Observer-blind study

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Feb 18, 2026

Anticipated Study Completion Date :

Feb 18, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [Day 1 to Month 12 (12 months postdelivery)]
Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.
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 [Day 1 (birth) to Month 12]
Birth outcomes will include gestational age and anthropometric measurements.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Research Associates - Flourish - PPDS	Birmingham	Alabama	United States	35205-1605
2	SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS	Dothan	Alabama	United States	36305-7376
3	Abby's Research Institute	Phoenix	Arizona	United States	85031-3878
4	Applied Research Center of Arkansas - ClinEdge - PPDS	Little Rock	Arkansas	United States	72212-4169
5	Matrix Clinical Research - Gardena	Gardena	California	United States	90247-4956
6	Matrix Clinical Research - Huntington Park	Huntington Park	California	United States	90255-2913
7	Matrix Clinical Research, Inc - Corporate Office	Los Angeles	California	United States	90057-4103
8	ARS - Fetal Diagnostic Center of Orlando - ERN - PPDS	Orlando	Florida	United States	32803-1465
9	Clinical Research Prime - ClinEdge - PPDS	Idaho Falls	Idaho	United States	83404-5305
10	Clinical Research Prime - ClinEdge - Rexburg - PPDS	Rexburg	Idaho	United States	83440-5390
11	Velocity Clinical Research - Covington - PPDS	Covington	Louisiana	United States	70433-7237
12	Saginaw Valley Medical Research Group LLC	Saginaw	Michigan	United States	48604-9533
13	Boeson Research GTF - Great Falls - ERN - PPDS	Great Falls	Montana	United States	59405-5316
14	Boeson Research KAL - Kalispell - ERN - PPDS	Kalispell	Montana	United States	59901-2158
15	Boeson Research MSO - Missoula - ERN - PPDS	Missoula	Montana	United States	59804-7401
16	Velocity Clinical Research (Grand Island - Nebraska) - PPDS	Grand Island	Nebraska	United States	68803-4327
17	Velocity Clinical Research (Hastings - Nebraska) - PPDS	Hastings	Nebraska	United States	68901-2615
18	Velocity Clinical Research (Norfolk - Nebraska) - PPDS	Norfolk	Nebraska	United States	68701-7701
19	DM Clinical Research - Birthing Center of New York - ERN - PPDS	Brooklyn	New York	United States	11220-5203
20	DM Clinical Research - Bellaire - ERN - PPDS	Houston	Texas	United States	77081
21	Maximos OB/GYN	League City	Texas	United States	77573-2681
22	Maternal Fetal Diagnostics Center	Salt Lake City	Utah	United States	84132-0001
23	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Ciudad Autónoma de Buenos Aires	Buenos Aires	Argentina	C1426
24	Clinica Privada Independencia	Munro	Buenos Aires	Argentina	B1605
25	Instituto Médico de la Fundación Estudios Clínicos	Rosario	Santa Fe, Argentina	Argentina	S2000DEJ
26	Expertia S.A- Mautalen Salud e Investigacion	Ciudad Autónoma de Buenos Aires		Argentina	C1128AAF
27	Instituto de Maternidad Nuestra Señora de La Merced	San Miguel de Tucumán		Argentina	T4000CPC
28	Clinica Mayo de U.M.C.B. S.R.L	San Miguel De Tucumán		Argentina	T4000IHE
29	BC Women's Hospital and Health Centre	Vancouver	British Columbia	Canada	V6H 3N1
30	Dalhousie University - 5820 University Ave	Halifax	Nova Scotia	Canada	B3H 1
31	Ottawa Hospital Civic Campus	Ottawa	Ontario	Canada	K1H 8L6
32	Sainte Justine Hospital	Montréal	Quebec	Canada	H3T 1C5
33	Centre Hospitalier de l'Université Laval	Quebec		Canada	G1V 4G2
34	Clínica Universidad de los Andes	Las Condes	Región-MetropolitanadeSantiago	Chile	7550000
35	Centro Internacional de Estudios Clínicos	Recoleta	Región-MetropolitanadeSantiago	Chile	8420000
36	Red Hospital Clinico de la Universidad de Chile	Santiago		Chile	8380453
37	Hvidovre Hospital	Hvidovre	Capital	Denmark	DK-2650
38	Aarhus Universitetshospital	Aarhus	Central Jutland	Denmark	8200
39	Regionshospitalet Gødstrup	Herning	Central Jutland	Denmark	7400
40	Sygehus Lillebaelt, Kolding	Kolding	South Denmark	Denmark	6000
41	Shonan Kamakura General Hospital	Kamakura-Shi	Kanagawa	Japan	247-8533
42	Saiseikai Yokohamashi Nanbu Hospital	Yokohama	Kanagawa	Japan	234-0054
43	Saitama City Hospital	Saitama-Shi	Saitama	Japan	336-0911
44	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-Ku	Tokyo	Japan	162-8655
45	Centro De Vacunacion Internacional, S.A. (Cevaxin) - David	David	Chiriquí	Panama
46	Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera	Ciudad De Panamá		Panama
47	Centro De Vacunacion Internacional, S.A. (Cevaxin)	Ciudad De Panamá		Panama
48	CEVAXIN 24 de diciembre	Panamá		Panama
49	Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama	Pueblo Nuevo		Panama
50	Josha Research	Bloemfontein	Free State	South Africa	9300
51	Bothe ke Bontle Health Services-316 Kuit st	Pretoria	Gauteng	South Africa	0184
52	Setshaba Research Centre	Soshanguve	Gauteng	South Africa	152
53	WITS Clinical Research Site - PPDS	Soweto	Gauteng	South Africa	2013
54	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo	South Africa	387
55	FAM-CRU	Cape Town	Western Cape	South Africa	7505
56	Royal Bournemouth Hospital	Bournemouth	Dorset	United Kingdom	BH7 7DW
57	Southampton General Hospital	Southampton	Hampshire	United Kingdom
58	The Royal London Hospital	London	London, City	United Kingdom	E1 1FR
59	The Royal Free Hospital	London	Middlesex	United Kingdom	NW3 2QG
60	Cardiff & Vale University Health Board-PPDS	Cardiff	South Glamorgan	United Kingdom	CF14 4XN
61	St George's Hospital	London	Surrey	United Kingdom	SW17 0QT
62	Glasgow Clinical Research Facility - PPDS	Glasgow		United Kingdom	G51 4TF