Clinical trial NCT05164094: A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
Official title: A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Epstein-Barr Virus Infection
Keywords: Infectious mononucleosis
Mononucleosis
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 867
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \<18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.


Eligibility criteria: Inclusion Criteria:

* According to the assessment of the investigator, is in good general health and can comply with study procedures.

Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

Part B:

Healthy baseline EBV-seronegative adolescents from 12 to \<18 years of age at the time of consent (Screening Visit, Day 0).

Part C:

Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

Exclusion Criteria:

* Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit.
* Has symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator).
* Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.
* Has a history of myocarditis, and/or pericarditis.
* Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: Up to Day 176 (7-day follow-up after vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 197 (28-day follow-up after vaccination)
measure: Number of Participants with SAEs, MAAEs, Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
timeFrame: Day 1 to end of study (EOS) (Day 505)
measure: Number of Participants with Laboratory Abnormalities
timeFrame: Up to Day 176 (7-day follow-up after vaccination)
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
timeFrame: Days 1, 85, and 197
measure: Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb
timeFrame: Days 1, 85, and 197
measure: Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs
timeFrame: Days 1, 85, and 197
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Institute
state: Alabama
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Anaheim
country: United States
facility: Smart Cures Clinical Research
state: California
city: Colton
country: United States
facility: Benchmark Research - Colton - HyperCore - PPDS
state: California
city: Oxnard
country: United States
facility: Fomat Medical Research
state: California
city: Paramount
country: United States
facility: Center For Clinical Trials LLC -Paramount
state: California
city: Riverside
country: United States
facility: Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
state: California
city: Rolling Hills
country: United States
facility: Peninsula Research Associates - Headlands Research - PPDS
state: California
city: San Bernardino
country: United States
facility: Velocity Clinical Research - Banning - PPDS
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation - 4180 Ruffin Rd
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Hollywood
country: United States
facility: Research Centers of America - ERG
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research - ERN - PPDS
state: Florida
city: Savannah
country: United States
facility: iResearch Savannah - CenExel - PPDS
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - Headlands - PPDS
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Olivo Medical and Wellness Center
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research
state: Illinois
city: Valparaiso
country: United States
facility: Velocity Clinical Research
state: Indiana
city: Sioux City
country: United States
facility: Meridian Clinical Research, LLC
state: Iowa
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research, LLC - El Dorado - PPDS
state: Kansas
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research LLC, East Wichita
state: Kansas
city: Lexington
country: United States
facility: Michael W Simon MD, PSC
state: Kentucky
city: Lafayette
country: United States
facility: Velocity Clinical Research - Lafayette - PPDS
state: Louisiana
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Saint Louis
country: United States
facility: Sundance Clinical Research - ERN - PPDS
state: Missouri
city: Grand Island
country: United States
facility: Meridian Clinical Research (Grand Island, Nebraska)
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research - ClinEdge - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC (Lincoln Nebraska)
state: Nebraska
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Nevada
city: Binghamton
country: United States
facility: Meridian Clinical Research
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research
state: New York
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: New Bern
country: United States
facility: Lucas Research
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research - Austin - PPDS
state: Texas
city: Austin
country: United States
facility: Tekton Research - Texas - Platinum - PPDS
state: Texas
city: Carrollton
country: United States
facility: ACRC Trials - Hunt - PPDS
state: Texas
city: Cedar Park
country: United States
facility: Velocity Clinical Research - Austin - PPDS
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research - Fort Worth - PPDS
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research - Fort Worth - HyperCore - PPDS
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Texas Center For Drug Development - ERN - PPDS
state: Texas
city: Plano
country: United States
facility: ACRC Trials - Legacy Medical Village Headquarters
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: Victoria
country: United States
facility: Victoria Clinical Research Group
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc. - Newport News
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners LLC - Richmond - ERN - PPDS
state: Virginia
Study officials:
References: