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A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05164094
Recruitment Status : Active, not recruiting
First Posted : December 20, 2021
Last Update Posted : November 21, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE December 1, 2021
First Posted Date  ICMJE December 20, 2021
Last Update Posted Date November 21, 2023
Actual Study Start Date  ICMJE December 28, 2021
Estimated Primary Completion Date June 18, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2023)
  • Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 176 (7-day follow-up after vaccination) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 197 (28-day follow-up after vaccination) ]
  • Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AEs of Special Interest (AESIs) [ Time Frame: Day 1 to end of study (EOS) (Day 505) ]
  • Number of Participants with Laboratory Abnormalities [ Time Frame: Up to Day 176 (7-day follow-up after vaccination) ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2021)
  • Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 176 ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 197 (28-day follow-up after vaccination) ]
  • Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AEs of Special Interest (AESIs) [ Time Frame: Day 1 to end of study (EOS) (Day 505) ]
  • Number of Participants with Laboratory Abnormalities [ Time Frame: Up to Day 176 (7-day follow-up after vaccination) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2021)
  • Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb) [ Time Frame: Days 1, 85, and 197 ]
  • Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb [ Time Frame: Days 1, 85, and 197 ]
  • Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs [ Time Frame: Days 1, 85, and 197 ]
    The number of initially EBV-negative participants with seroconversion from below the lower limit of quantification (LLOQ) to above the LLOQ for EBV-specific (vaccine antigen) binding and nAbs responses and the initially EBV-positive participants with > 2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline (if above LLOQ) will be analyzed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults
Official Title  ICMJE A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults
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 and the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old EBV-seronegative healthy adolescents.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Epstein-Barr Virus Infection
Intervention  ICMJE
  • Biological: mRNA-1189
    Sterile liquid for injection
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection
Study Arms  ICMJE
  • Experimental: Part A: mRNA-1189 Dose Level 2
    Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Experimental: Part A: mRNA-1189 Dose Level 3
    Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Experimental: Part A: mRNA-1189 Dose Level 4
    Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Placebo Comparator: Part A: Placebo
    Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
    Intervention: Biological: Placebo
  • Experimental: Part B: mRNA-1189 Dose Level 1
    Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Experimental: Part B: mRNA-1189 Dose Level 2
    Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Experimental: Part B: mRNA-1189 Dose Level 3
    Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Experimental: Part B: mRNA-1189 Dose Level 4
    Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
    Intervention: Biological: mRNA-1189
  • Placebo Comparator: Part B: Placebo
    Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2023)
422
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2021)
272
Estimated Study Completion Date  ICMJE June 18, 2025
Estimated Primary Completion Date June 18, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 adolescent from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).

EBV - seronegative as determined by serology at screening.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05164094
Other Study ID Numbers  ICMJE mRNA-1189-P101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ModernaTX, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ModernaTX, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP