A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Cytomegalovirus Clinical Trial

Official title:

A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05575492
• Other study ID #: mRNA-1647-P104
• Secondary ID: 2022-001545-20
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 7, 2022
• Est. completion date: January 15, 2027

Study information

• Verified date: April 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition, mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.

Description:

The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 770
• Est. completion date: January 15, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 25 Years

Eligibility

Key Inclusion Criteria:

• Is a female or male 9 to 15 years of age or is a female 16 to 25 years of age at the time of consent.
• Is in good general health, in the opinion of the Investigator, and is capable of complying with study procedures.
• For the CMV-seronegative cohorts: At the Screening visit, is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative.
• For CMV-seropositive cohorts: At the Screening visit, is CMV IgG-positive and CMV IgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMV IgM-indeterminate. Participants with an isolated positive or indeterminate result for CMV IgM (that is, CMV IgG-negative and either CMV IgM-positive or CMV IgM-indeterminate) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV Screening. Participants with an indeterminate result for CMV IgG, regardless of IgM result, will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV screening.
• If 9 to 15 years of age, has a body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards. If 16 to 25 years of age: has a BMI of 15 to 35 kilograms (kg)/square meter (m^2).
• For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration.

Key Exclusion Criteria:

• Has a history of a diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
• Has received, or plans to receive, any nonstudy vaccine < 28 days prior to or after any study injection.
• Has a screening liver function test (aspartate aminotransferase, alanine aminotransferase, total bilirubin) or a screening creatinine result of Toxicity Grade =1.
• Has a Screening hematology or coagulation result of Toxicity Grade =1.
• Is acutely ill or febrile (body temperature =38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) at the Screening Visit.
• Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to the day of enrollment (for corticosteroids, =1 milligrams (mg)/kg/day or =10 mg/day prednisone equivalent).
• Has received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of the first study injection (Day 1) or plans to do so during the course of the study.
• Reports a history of myocarditis, pericarditis, or myopericarditis.
• Has reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV 1 or 2 antibodies.
• Has previously received an investigational CMV vaccine.
• Has received systemic immunoglobulins or blood products <3 months prior to the day of the first study injection (Day 1).
• Has donated = 450 milliliter (mL) of blood products <28 days prior to the day of the first study injection (Day 1).
• Has participated in an interventional clinical study <28 days prior to the day of the first study injection (Day 1) or plans to do so while enrolled in the study. Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Cytomegalovirus

Intervention

Biological:
• mRNA-1647
Sterile liquid for injection

Other:
• Placebo
0.9% sodium chloride injection (normal saline)

Locations

Country	Name	City	State
Canada	M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary	Calgary	Alberta
Canada	ALTA Clinical Research Inc	Edmonton	Alberta
Canada	Canadian Center for Vaccinology	Halifax	Nova Scotia
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec
Canada	CARe Clinic	Red Deer	Alberta
Canada	Bluewater Clinical Research Group	Sarnia	Ontario
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire
United Kingdom	Noah's Ark Children's Hospital for Wales	Cardiff
United Kingdom	Lakeside Healthcare	Corby	Northamptonshire
United Kingdom	St. George Hospital	London
United Kingdom	Manchester Royal Infirmary - PPDS	Manchester	Lancashire
United Kingdom	Sheffield Children's Hospital	Sheffield	South Yorkshire
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United States	Albuquerque Clinical Trials Inc - Clinedge - PPDS	Albuquerque	New Mexico
United States	Velocity Clinical Research -Albuquerque -PPDS	Albuquerque	New Mexico
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Tekton Research - Texas - PPDS	Austin	Texas
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Tekton Research - Beaumont - Platinum - PPDS	Beaumont	Texas
United States	Velocity Clinical Research (Binghamton - New York) - PPDS	Binghamton	New York
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Tekton Research - Georgia - Platinum - PPDS	Chamblee	Georgia
United States	OnSite Clinical Solutions, LLC - ClinEdge - PPDS	Charlotte	North Carolina
United States	Centricity Research Roswell	Columbus	Georgia
United States	Benchmark Research - Covington - HyperCore- PPDS	Covington	Louisiana
United States	iResearch Atlanta - CenExel - PPDS	Decatur	Georgia
United States	Wayne State University	Detroit	Michigan
United States	Prohealth Research Center	Doral	Florida
United States	BRCR Global Texas	Edinburg	Texas
United States	Tekton Research - Oklahoma- PPDS	Edmond	Oklahoma
United States	Tekton Research - Fort Collins - Platinum - PPDS	Fort Collins	Colorado
United States	Benchmark Research - Fort Worth - HyperCore -PPDS	Fort Worth	Texas
United States	The Pediatric Centre of Frederick	Frederick	Maryland
United States	University of Texas Medical Branch (UTMB)	Galveston	Texas
United States	Velocity Clinical Research - Gulfport	Gulfport	Mississippi
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Bipharma Informatic -Cardiff Avenue - PPDS	Houston	Texas
United States	West Houston Clinical Research - Hunt - PPDS	Houston	Texas
United States	Clinical Research Prime - ClinEdge - PPDS	Idaho Falls	Idaho
United States	Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)	Jacksonville	Florida
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	Paradigm Clinical Research Institute Inc - ClinEdge - PPDS	La Mesa	California
United States	Velocity Clinical Research - San Diego - PPDS	La Mesa	California
United States	Velocity Clinical Research (Lincoln-Nebraska) - PPDS	Lincoln	Nebraska
United States	Velocity Clinical Research - Medford - PPDS	Medford	Oregon
United States	Meharry Medical College	Nashville	Tennessee
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Alliance for Multispecialty Research, LLC - Norfolk	Norfolk	Virginia
United States	Velocity Clinical Research (Norfolk - Nebraska) - PPDS	Norfolk	Nebraska
United States	Lynn Institute of Norman - ERN - PPDS	Norman	Oklahoma
United States	Coastal Carolina Research Center - PPDS	North Charleston	South Carolina
United States	Velocity Clinical Research (Omaha-Nebraska) - Platinum - PPDS	Omaha	Nebraska
United States	Clinical Neurosciences Solutions Inc. (Orlando-East South St)	Orlando	Florida
United States	Victoria Clinical Research Group	Port Lavaca	Texas
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Benchmark Research - Sacramento -Hypercore- PPDS	Sacramento	California
United States	JBR Clinical Research - CenExel JBR - PPDS	Salt Lake City	Utah
United States	Benchmark Research - San Angelo - HyperCore - PPDS	San Angelo	Texas
United States	Tekton Research - Texas - Platinum - PPDS	San Antonio	Texas
United States	MultiCare Institute for Research and Innovation	Spokane	Washington
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Palm Harbor Dermatology	Tampa	Florida
United States	Santos Research Center	Tampa	Florida
United States	DM Clinical Research - ERN- PPDS	Tomball	Texas
United States	Crossroads Clinical Research (Victoria)	Victoria	Texas
United States	Velocity Clinical Research (Washington)- PPDS	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 176 (7 days after each study injection)
Primary	Number of Unsolicited Adverse Events (AEs)		Up to Day 197 (28 days after each study injection)
Primary	Number of Medically Attended Adverse Events (MAAEs)		Up to Day 347 (6 months after the last study injection)
Primary	Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation		Up to Day 527 (end of study)
Primary	Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs)	Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.	Up to Day 527 (end of study)
Primary	Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs	Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.	Up to Day 527 (end of study)
Primary	Number of Participants with =2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies	Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.	Up to Day 527 (end of study)
Secondary	Geometric Mean Concentration (GMC) of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG	Serum antigen-specific binding antibody titers against vaccine antigens will be measured by enzyme-linked immunosorbent assay (ELISA) specific to the gB and pentamer proteins.	Up to Day 527 (end of study)
Secondary	Number of Participants with =2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG	Serum antigen-specific binding antibody titers against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.	Up to Day 527 (end of study)
Secondary	GMFR of Binding Anti-gB and Anti-pentamer Specific IgG	Serum antigen-specific binding antibody concentrations against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.	Up to Day 527 (end of study)