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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04232280
Collaborator
(none)
315
9
4
35.7
35
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA-1647
  • Other: Placebo
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
315 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Observer-Blind
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 9, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: mRNA-1647 Low Dose

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

Biological: mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Experimental: mRNA-1647 Medium Dose

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

Biological: mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Experimental: mRNA-1647 High Dose

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

Biological: mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Placebo Comparator: Placebo

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

Other: Placebo
0.9% sodium chloride (normal saline) injection

Outcome Measures

Primary Outcome Measures

  1. Frequency of Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 175 (7 days following last dose administration)]

  2. Frequency of Unsolicited Adverse Events (AEs) [Up to Day 196 (28 days following last dose administration)]

  3. Frequency of Medically-Attended Adverse Events (MAAEs) [Up to Day 336 (6 months following last dose administration)]

  4. Frequency of Serious Adverse Events (SAEs) [Up to Day 504 (1 year following last dose administration)]

  5. Change from Baseline in Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection [Baseline, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

  6. 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 [Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504]

Secondary Outcome Measures

  1. 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 [Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

  2. 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 [Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

  3. 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 [Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

  4. 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 [Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

  5. 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 [Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504]

  6. Change from Baseline in GMT of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups [Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

  7. Change from Baseline in GMR of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups [Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Benchmark Research Sacramento California United States 95864
2 Optimal Research Peoria Illinois United States 61614
3 Johnson County Clin-Trials Lenexa Kansas United States 66219
4 Alliance for Multispecialty Research Lexington Kentucky United States 40509
5 Aventiv Research Inc Columbus Ohio United States 43213-6523
6 Tekton Research Inc Austin Texas United States 78745
7 Crossroads Clinical Research Victoria Texas United States 77901
8 Foothill Family Clinic Salt Lake City Utah United States 84109
9 Foothill Family Clinic-South Clinic Salt Lake City Utah United States 84121

Sponsors and Collaborators

  • ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ModernaTX, Inc.
ClinicalTrials.gov Identifier:
NCT04232280
Other Study ID Numbers:
  • mRNA-1647-P202
First Posted:
Jan 18, 2020
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ModernaTX, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2021