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Trial record 1 of 1 for:    NCT05164094
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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

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epstein-Barr Virus Infection Biological: mRNA-1189 Biological: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : June 18, 2025
Estimated Study Completion Date : June 18, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: mRNA-1189
Sterile liquid for injection
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.
 Biological: mRNA-1189
Sterile liquid for injection
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.
 Biological: mRNA-1189
Sterile liquid for injection
Placebo Comparator: Part A: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
 Biological: Placebo
0.9% sodium chloride (normal saline) injection
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.
 Biological: mRNA-1189
Sterile liquid for injection
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.
 Biological: mRNA-1189
Sterile liquid for injection
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.
 Biological: mRNA-1189
Sterile liquid for injection
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.
 Biological: mRNA-1189
Sterile liquid for injection
Placebo Comparator: Part B: Placebo
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
 Biological: Placebo
0.9% sodium chloride (normal saline) injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 176 (7-day follow-up after vaccination) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 197 (28-day follow-up after vaccination) ]
  3. 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) ]
  4. Number of Participants with Laboratory Abnormalities [ Time Frame: Up to Day 176 (7-day follow-up after vaccination) ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb) [ Time Frame: Days 1, 85, and 197 ]
  2. Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb [ Time Frame: Days 1, 85, and 197 ]
  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05164094


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05164094    
Other Study ID Numbers: mRNA-1189-P101
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
Infectious mononucleosis
Mononucleosis
Additional relevant MeSH terms:
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Epstein-Barr Virus Infections
Virus Diseases
Infections
 Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections