Clinical trial NCT05575492: A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cytomegalovirus
Keywords: mRNA-1647 Vaccine
CMV
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 860
Sex: ALL
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1: Dose-escalating, non-randomized Part 2: Randomized
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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 the 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.

Primary outcomes:
measure: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: Up to Day 176 (7 days after each study injection)
measure: Number of Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 197 (28 days after each study injection)
measure: Number of Medically Attended Adverse Events (MAAEs)
timeFrame: Up to Day 347 (6 months after the last study injection)
measure: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
timeFrame: Up to Day 527 (end of study)
measure: Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs)
timeFrame: Up to Day 527 (end of study)
measure: Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs
timeFrame: Up to Day 527 (end of study)
measure: Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies
timeFrame: Up to Day 527 (end of study)
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG
timeFrame: Up to Day 527 (end of study)
measure: Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG
timeFrame: Up to Day 527 (end of study)
measure: GMFR of Binding Anti-gB and Anti-pentamer Specific IgG
timeFrame: Up to Day 527 (end of study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: La Mesa
country: United States
facility: Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego - PPDS
state: California
city: Sacramento
country: United States
facility: Benchmark Research - Sacramento -Hypercore- PPDS
state: California
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins - Platinum - PPDS
state: Colorado
city: Washington
country: United States
facility: Velocity Clinical Research (Washington)- PPDS
state: District of Columbia
city: Doral
country: United States
facility: Prohealth Research Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd)
state: Florida
city: Orlando
country: United States
facility: Clinical Neurosciences Solutions Inc. (Orlando-East South St)
state: Florida
city: Tampa
country: United States
facility: Palm Harbor Dermatology
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chamblee
country: United States
facility: Tekton Research - Georgia - Platinum - PPDS
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Roswell
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta - CenExel - PPDS
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime - ClinEdge - PPDS
state: Idaho
city: Covington
country: United States
facility: Benchmark Research - Covington - HyperCore- PPDS
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Columbia
country: United States
facility: The Pediatric Centre
state: Maryland
city: Frederick
country: United States
facility: The Pediatric Centre of Frederick
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Gulfport
country: United States
facility: Velocity Clinical Research - Gulfport
state: Mississippi
city: Lincoln
country: United States
facility: Velocity Clinical Research (Lincoln-Nebraska) - PPDS
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research (Norfolk - Nebraska) - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research (Omaha-Nebraska) - Platinum - PPDS
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials Inc - Clinedge - PPDS
state: New Mexico
city: Albuquerque
country: United States
facility: Velocity Clinical Research -Albuquerque -PPDS
state: New Mexico
city: Binghamton
country: United States
facility: Velocity Clinical Research (Binghamton - New York) - PPDS
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC - ClinEdge - PPDS
state: North Carolina
city: Edmond
country: United States
facility: Tekton Research - Oklahoma- PPDS
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman - ERN - PPDS
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research - Medford - PPDS
state: Oregon
city: North Charleston
country: United States
facility: Coastal Carolina Research Center - PPDS
state: South Carolina
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Austin
country: United States
facility: Tekton Research - Texas - PPDS
state: Texas
city: Beaumont
country: United States
facility: Tekton Research - Beaumont - Platinum - PPDS
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Edinburg
country: United States
facility: BRCR Global Texas
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth - HyperCore -PPDS
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch (UTMB)
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research - Hunt - PPDS
state: Texas
city: Houston
country: United States
facility: Bipharma Informatic -Cardiff Avenue - PPDS
state: Texas
city: Port Lavaca
country: United States
facility: Victoria Clinical Research Group
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo - HyperCore - PPDS
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - Texas - Platinum - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN- PPDS
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research (Victoria)
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research - CenExel JBR - PPDS
state: Utah
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC - Norfolk
state: Virginia
city: Spokane
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Calgary
country: Canada
facility: M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary
state: Alberta
city: Edmonton
country: Canada
facility: ALTA Clinical Research Inc
state: Alberta
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary - PPDS
state: Lancashire
city: Corby
country: United Kingdom
facility: Lakeside Healthcare
state: Northamptonshire
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: Noah's Ark Children's Hospital for Wales
city: London
country: United Kingdom
facility: St. George Hospital
Study officials:
References: