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Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

Primary Purpose

Cytomegalovirus Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mRNA-1647
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2)
  • Understands and agrees to comply with the trial procedures and provides written informed consent
  • According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures
  • Body mass index (BMI) 18-35 kilograms/meter (kg/m^2)
  • Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding.
  • Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after the last vaccination.

Exclusion Criteria:

  • Acutely ill or febrile on the day of the first vaccination
  • Prior receipt of any CMV vaccine
  • Abnormal screening safety laboratory test results
  • 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 trial procedures
  • Has received or plans to receive a vaccine ≤28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered >14 days before or after any study vaccination. COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations.
  • Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
  • Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
  • Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only)
  • Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit
  • Participated in an interventional clinical trial within 28 days prior to the day of enrollment
  • Is an immediate family member or household member of trial personnel

Sites / Locations

  • Benchmark Research
  • Optimal Research
  • Johnson County Clin-Trials
  • Alliance for Multispecialty Research
  • Aventiv Research Inc
  • Tekton Research Inc
  • Crossroads Clinical Research
  • Foothill Family Clinic
  • Foothill Family Clinic-South Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

mRNA-1647 Low Dose

mRNA-1647 Medium Dose

mRNA-1647 High Dose

Placebo

Arm Description

Participants will receive mRNA-1647 vaccine at the Low Dose by intramuscular (IM) injection on Day 1, Day 56, and Day 168.

Participants will receive mRNA-1647 vaccine at the Medium Dose by IM injection on Day 1, Day 56, and Day 168.

Participants will receive mRNA-1647 vaccine at the High Dose by IM injection on Day 1, Day 56, and Day 168.

Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.

Outcomes

Primary Outcome Measures

Frequency of Solicited Local and Systemic Adverse Reactions (ARs)
Frequency of Unsolicited Adverse Events (AEs)
Frequency of Medically-Attended Adverse Events (MAAEs)
Frequency of Serious Adverse Events (SAEs)
Change from Baseline in Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection

Secondary Outcome Measures

Change from Baseline in GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Change from Baseline in Associated GMR of Anti-gB Specific IgG and Anti-Pentamer Specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Change from Baseline in GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Change from Baseline in GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Change from Baseline in GMT of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Change from Baseline in GMR of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups

Full Information

First Posted
January 9, 2020
Last Updated
January 11, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04232280
Brief Title
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Official Title
A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
Detailed Description
mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity of low, medium, and high dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A planned interim analysis of safety and immunogenicity through Month 3 (1 month after the second dose) of Part 1 of the study informed the selection of the middle dose level for further development. Part 2 of the study is designed to further evaluate the safety and immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of CMV-seronegative and CMV-seropositive female population, which includes the target population for the pivotal Phase 3 efficacy trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
Observer-Blind
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1647 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1647 vaccine at the Low Dose by intramuscular (IM) injection on Day 1, Day 56, and Day 168.
Arm Title
mRNA-1647 Medium Dose
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1647 vaccine at the Medium Dose by IM injection on Day 1, Day 56, and Day 168.
Arm Title
mRNA-1647 High Dose
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1647 vaccine at the High Dose by IM injection on Day 1, Day 56, and Day 168.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.
Intervention Type
Biological
Intervention Name(s)
mRNA-1647
Intervention Description
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Primary Outcome Measure Information:
Title
Frequency of Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 175 (7 days following last dose administration)
Title
Frequency of Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 196 (28 days following last dose administration)
Title
Frequency of Medically-Attended Adverse Events (MAAEs)
Time Frame
Up to Day 336 (6 months following last dose administration)
Title
Frequency of Serious Adverse Events (SAEs)
Time Frame
Up to Day 504 (1 year following last dose administration)
Title
Change from Baseline in Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Time Frame
Baseline, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Title
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Time Frame
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504
Secondary Outcome Measure Information:
Title
Change from Baseline in GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Time Frame
Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Title
Change from Baseline in Associated GMR of Anti-gB Specific IgG and Anti-Pentamer Specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Time Frame
Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Title
Change from Baseline in GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Time Frame
Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Title
Change from Baseline in GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Time Frame
Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Title
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Time Frame
Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504
Title
Change from Baseline in GMT of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Time Frame
Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Title
Change from Baseline in GMR of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Time Frame
Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2) Understands and agrees to comply with the trial procedures and provides written informed consent According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures Body mass index (BMI) 18-35 kilograms/meter (kg/m^2) Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding. Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after the last vaccination. Exclusion Criteria: Acutely ill or febrile on the day of the first vaccination Prior receipt of any CMV vaccine Abnormal screening safety laboratory test results 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 trial procedures Has received or plans to receive a vaccine ≤28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered >14 days before or after any study vaccination. COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations. Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only) Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit Participated in an interventional clinical trial within 28 days prior to the day of enrollment Is an immediate family member or household member of trial personnel
Facility Information:
Facility Name
Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Alliance for Multispecialty Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213-6523
Country
United States
Facility Name
Tekton Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Crossroads Clinical Research
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Foothill Family Clinic-South Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

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