Clinical trial NCT06143046: A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Respiratory Syncytial Virus
Keywords: mRNA-1345
RSV vaccine
Viral Diseases
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.
* Intend for their infant to receive RSV monoclonal antibodies after delivery.

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.

Primary outcomes:
measure: Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 7 (7 days post vaccination)
measure: Number of Maternal Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 28 (28 days post vaccination)
measure: Number of Maternal Participants with Medically-Attended AEs (MAAEs)
timeFrame: Day 1 to Month 6 (6 months postdelivery)
measure: Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 to Month 12 (12 months postdelivery)
measure: Number of Maternal Participants with Serious Adverse Events (SAEs)
timeFrame: Day 1 to Month 12 (12 months postdelivery)
measure: Number of Maternal Participants with AEs Leading to Discontinuation
timeFrame: Day 1 to Month 12 (12 months postdelivery)
measure: Number of Maternal Participants With Pregnancy Outcomes
timeFrame: Day 1 to Month 12 (12 months postdelivery)
measure: Number of Infant Participants with MAAEs
timeFrame: Day 1 (birth) to Month 12
measure: Number of Infant Participants with AESIs
timeFrame: Day 1 (birth) to Month 12
measure: Number of Infant Participants with SAEs
timeFrame: Day 1 (birth) to Month 12
measure: Number of Infant Participants With Birth Outcomes
timeFrame: Day 1 (birth) to Month 12
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants
timeFrame: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
measure: Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants
timeFrame: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
measure: Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants
timeFrame: Day 29, delivery, and Month 6 (6 months postdelivery)
measure: Percentage of Maternal Participants With ≥4-fold Increase From Baseline in Neutralizing Antibody Titers and Binding Antibody Concentrations
timeFrame: Baseline up to Month 6 (6 months postdelivery)
measure: GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants
timeFrame: Day 1 (birth), and Months 2, 6, and 12
measure: GMC of Serum RSV-F Binding Antibodies in Infant Participants
timeFrame: Day 1 (birth), and Months 2, 6, and 12
Other outcomes:
Locations:
city: Dothan
country: United States
facility: SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
state: Alabama
city: Phoenix
country: United States
facility: Abby's Research Institute
state: Arizona
city: Tucson
country: United States
facility: Watching Over Mothers & Babies
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas - ClinEdge - PPDS
state: Arkansas
city: Gardena
country: United States
facility: Matrix Clinical Research - Gardena
state: California
city: Huntington Park
country: United States
facility: Matrix Clinical Research - Huntington Park
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research, Inc - Corporate Office
state: California
city: Idaho Falls
country: United States
facility: Clinical Research Prime - ClinEdge - PPDS
state: Idaho
city: Pocatello
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Rexburg
country: United States
facility: Clinical Research Prime - ClinEdge - Rexburg - PPDS
state: Idaho
city: Covington
country: United States
facility: Velocity Clinical Research - Covington - PPDS
state: Louisiana
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group LLC
state: Michigan
city: Great Falls
country: United States
facility: Boeson Research GTF - Great Falls - ERN - PPDS
state: Montana
city: Kalispell
country: United States
facility: Boeson Research KAL - Kalispell - ERN - PPDS
state: Montana
city: Missoula
country: United States
facility: Boeson Research MSO - Missoula - ERN - PPDS
state: Montana
city: Grand Island
country: United States
facility: Velocity Clinical Research (Grand Island - Nebraska) - PPDS
state: Nebraska
city: Hastings
country: United States
facility: Velocity Clinical Research (Hastings - Nebraska) - PPDS
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research (Norfolk - Nebraska) - PPDS
state: Nebraska
city: Houston
country: United States
facility: DM Clinical Research - Bellaire - ERN - PPDS
state: Texas
city: League City
country: United States
facility: Maximos OB/GYN
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Maternal Fetal Diagnostics Center
state: Utah
city: Halifax
country: Canada
facility: Dalhousie University - 5820 University Ave
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Montréal
country: Canada
facility: Sainte Justine Hospital
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier de l'Université Laval
city: Las Condes
country: Chile
facility: Clínica Universidad de los Andes
state: Región-MetropolitanadeSantiago
city: Recoleta
country: Chile
facility: Centro Internacional de Estudios Clínicos
state: Región-MetropolitanadeSantiago
city: Santiago
country: Chile
facility: Red Hospital Clinico de la Universidad de Chile
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Capital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
state: Central Jutland
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
state: Central Jutland
city: Kamakura-Shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital
state: Kanagawa
city: Saitama-Shi
country: Japan
facility: Saitama City Hospital
state: Saitama
city: Shinjuku-Ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: David
country: Panama
facility: Centro De Vacunacion Internacional, S.A. (Cevaxin) - David
state: Chiriquí
city: Ciudad De Panamá
country: Panama
facility: Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
city: Ciudad De Panamá
country: Panama
facility: Centro De Vacunacion Internacional, S.A. (Cevaxin)
city: Panamá
country: Panama
facility: CEVAXIN 24 de diciembre
city: Pueblo Nuevo
country: Panama
facility: Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama
city: Bloemfontein
country: South Africa
facility: Josha Research
state: Free State
city: Welkom
country: South Africa
facility: Drs. YAK Vahed & Partners
state: Free State
city: Krugersdorp
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Bothe ke Bontle Health Services-316 Kuit st
state: Gauteng
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre
state: Gauteng
city: Soweto
country: South Africa
facility: WITS Clinical Research Site - PPDS
state: Gauteng
city: Middelburg
country: South Africa
facility: Merclinico Middelburg
state: Mpumalanga
city: Cape Town
country: South Africa
facility: FAM-CRU
state: Western Cape
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: London
country: United Kingdom
facility: The Royal London Hospital
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Free Hospital
state: Middlesex
city: Cardiff
country: United Kingdom
facility: Cardiff & Vale University Health Board-PPDS
state: South Glamorgan
city: London
country: United Kingdom
facility: St George's Hospital
state: Surrey
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility - PPDS
Study officials:
References: