Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRN… (NCT04232280) | Clinical Trial Compass
CompletedPhase 2
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
United States315 participantsStarted 2020-01-09
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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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 manufac…
What they're measuring
1
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to Day 175 (7 days following last dose administration)
2
Number of Participants With Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 196 (28 days following last dose administration)
3
Number of Participants With Medically Attended Adverse Events (MAAEs)
Timeframe: Up to Day 336 (6 months following last dose administration)
4
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to Day 504 (1 year following last dose administration)
5
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Timeframe: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
6
Geometric Mean Ratio (GMR) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Timeframe: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
7
Percentage 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