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

Cytomegalovirus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232280
• Other study ID #: mRNA-1647-P202
• Status: Completed
• Phase: Phase 2
• Start date: January 9, 2020
• Est. completion date: January 4, 2023

Study information

• Verified date: December 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Intervention

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

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

Locations

Country	Name	City	State
United States	Tekton Research Inc	Austin	Texas
United States	Aventiv Research Inc	Columbus	Ohio
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Alliance for Multispecialty Research	Lexington	Kentucky
United States	Optimal Research	Peoria	Illinois
United States	Benchmark Research	Sacramento	California
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	Foothill Family Clinic-South Clinic	Salt Lake City	Utah
United States	Crossroads Clinical Research	Victoria	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 175 (7 days following last dose administration)
Primary	Frequency of Unsolicited Adverse Events (AEs)		Up to Day 196 (28 days following last dose administration)
Primary	Frequency of Medically-Attended Adverse Events (MAAEs)		Up to Day 336 (6 months following last dose administration)
Primary	Frequency of Serious Adverse Events (SAEs)		Up to Day 504 (1 year following last dose administration)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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