Cytomegalovirus Infection
Conditions
Keywords
Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA
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 3 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.
Interventions
BIOLOGICALmRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
OTHERPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Observer-Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 |
| 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 |
Countries
United States
Outcome results
None listed