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

• ClinicalTrials.gov Identifier: NCT05164094
• Recruitment Status: Active, not recruiting
• First Posted: December 20, 2021
• Last Update Posted: November 21, 2023
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: December 1, 2021
• First Posted Date: December 20, 2021
• Last Update Posted Date: November 21, 2023
• Actual Study Start Date: December 28, 2021
• Estimated Primary Completion Date: June 18, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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) ]

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Epstein-Barr Virus Infection

Intervention

• Biological: mRNA-1189
  Sterile liquid for injection
• Biological: Placebo
  0.9% sodium chloride (normal saline) injection

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 6, 2023): 422
• Original Estimated Enrollment (submitted: December 17, 2021): 272
• Estimated Study Completion Date: June 18, 2025
• Estimated Primary Completion Date: June 18, 2025 (Final data collection date for primary outcome measure)

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 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

• Sexes Eligible for Study: All

• Ages: 12 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05164094
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: November 2023