Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
- Frequency of Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 175 (7 days following last dose administration)]
- Frequency of Unsolicited Adverse Events (AEs) [Up to Day 196 (28 days following last dose administration)]
- Frequency of Medically-Attended Adverse Events (MAAEs) [Up to Day 336 (6 months following last dose administration)]
- Frequency of Serious Adverse Events (SAEs) [Up to Day 504 (1 year following last dose administration)]
- 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]
- 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
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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
Inclusion Criteria:
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Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2)
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Understands and agrees to comply with the trial procedures and provides written informed consent
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According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures
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Body mass index (BMI) 18-35 kilograms/meter (kg/m^2)
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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.
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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:
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Acutely ill or febrile on the day of the first vaccination
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Prior receipt of any CMV vaccine
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Abnormal screening safety laboratory test results
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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
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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.
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Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
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Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
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Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only)
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Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit
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Participated in an interventional clinical trial within 28 days prior to the day of enrollment
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Is an immediate family member or household member of trial personnel
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- mRNA-1647-P202