Cytomegalovirus InfectionPhase 1NCT05105048
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647
A Phase 1 study testing mRNA-1647 in people with Cytomegalovirus Infection, run by ModernaTX, Inc. at 3 sites in United States.
Trial summary
The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- mRNA-1647
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Nov 2021to 10 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is a Japanese Adult 18-40 years of age at the time of consent who, in the opinion of the investigator, is in good health based on review of medical history and screening physical examination. Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan, and who have not lived outside of Japan for more than 10 years in total.
- For the CMV-seronegative groups: Participant is serum CMV IgG negative/ IgM negative.
- For the CMV-seropositive groups: Participant is either serum CMV IgG positive/IgM negative or IgG positive/IgM positive.
- Participant has a body mass index (BMI) from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2, inclusive.
Who cannot join
- History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
- Participant has elevated liver function tests, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP), or elevated creatinine or reduced platelets, with a toxicity score of Grade ≥1 at screening.
- Participant has laboratory test results (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥1 at screening.
- Received or plans to receive any non-study vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
- Any COVID-19 vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.
- COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
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- Influenza vaccines may be administered >14 days prior to or after any study injection.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before the day of first injection (Day 1) (for corticosteroids, >5 mg/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed.
- Participant has received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) within 2 weeks before the first injection or plans to do so during the course of the study.
- Participant received any investigational CMV vaccine.
- History of myocarditis, pericarditis, or myopericarditis.
- Reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HbSAg), hepatitis C antibodies, or HIV 1 or 2 antibodies.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Velocity Clinical Research
North Hollywood, California, 91606
California Research Foundation
San Diego, California, 92123
About this study
Official title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 When Administered to Healthy Japanese Adults (18-40 Years of Age) in the United States
The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.
- Conditions
- Cytomegalovirus Infection
- Being tested
- mRNA-1647, Placebo
- Keywords
- Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, Messenger RNA
- Medical subject headings
- Cytomegalovirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1647Biological
Lyophilized product that is reconstituted with saline
PlaceboBiological
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1647 | Experimental | CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule. Receives: Biological: mRNA-1647 |
| Placebo | Placebo comparator | CMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to Day 176 (7 days after each injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Measured: Up to Day 197 (28 days after each injection)
Number of Participants With Medically-Attended AEs (MAAEs)
Measured: Day 1 through 6 months after the last injection (up to Day 347)
Number of Participants With Serious AEs (SAEs)
Measured: Day 1 through End of Study (EOS) (up to Day 347)
Number of Participants With AEs of Special Interest (AESIs)
Measured: Day 1 through EOS (up to Day 347)
Secondary outcomes (6)
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies (nAbs) Against Epithelial Cell Infection and Against Fibroblast Infection
Measured: Days 1, 29, 85, 169, 197, and 347
Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Measured: Days 29, 85, 169, 197, and 347
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in nAb over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Measured: Days 29, 85, 169, 197, and 347
GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: Days 1, 29, 85, 169, 197, and 347
GMFR of Anti-gB and Anti-Pentamer Specific IgG
Measured: Days 29, 85, 169, 197, and 347
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline in Anti-gB and Anti-Pentamer Specific IgG
Measured: Days 29, 85, 169, 197, and 347
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start8 Nov 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105048
- Sponsor's protocol ID
- mRNA-1647-P103
- Status last verified
- Sep 2023
- First submitted
- 22 Oct 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 When Administered to Healthy Japanese Adults (18-40 Years of Age) in the United States
- ClinicalTrials.gov ID
- NCT05105048
- Acronym / sponsor ID
- mRNA-1647-P103
- Conditions
- Cytomegalovirus Infection
- Keywords
- Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-1647 | Experimental | Biological: mRNA-1647CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule. |
| Placebo | Placebo comparator | Biological: PlaceboCMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is a Japanese Adult 18-40 years of age at the time of consent who, in the opinion of the investigator, is in good health based on review of medical history and screening physical examination. Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan, and who have not lived outside of Japan for more than 10 years in total.
- For the CMV-seronegative groups: Participant is serum CMV IgG negative/ IgM negative.
- For the CMV-seropositive groups: Participant is either serum CMV IgG positive/IgM negative or IgG positive/IgM positive.
- Participant has a body mass index (BMI) from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2, inclusive.
Key exclusion criteria (13 listed)
- History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
- Participant has elevated liver function tests, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP), or elevated creatinine or reduced platelets, with a toxicity score of Grade ≥1 at screening.
- Participant has laboratory test results (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥1 at screening.
- Received or plans to receive any non-study vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
- COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1647Lyophilized product that is reconstituted with saline | Biological | mRNA-1647 |
| Placebo0.9% sodium chloride (normal saline) injection | Biological | Placebo |
Primary outcome
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 176 (7 days after each injection)
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28 days after each injection)
Number of Participants With Medically-Attended AEs (MAAEs)
Time frame: Day 1 through 6 months after the last injection (up to Day 347)
Number of Participants With Serious AEs (SAEs)
Time frame: Day 1 through End of Study (EOS) (up to Day 347)
Number of Participants With AEs of Special Interest (AESIs)
Time frame: Day 1 through EOS (up to Day 347)
6 secondary outcomes
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies (nAbs) Against Epithelial Cell Infection and Against Fibroblast Infection
Time frame: Days 1, 29, 85, 169, 197, and 347
Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Time frame: Days 29, 85, 169, 197, and 347
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in nAb over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Time frame: Days 29, 85, 169, 197, and 347
GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Days 1, 29, 85, 169, 197, and 347
GMFR of Anti-gB and Anti-Pentamer Specific IgG
Time frame: Days 29, 85, 169, 197, and 347
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline in Anti-gB and Anti-Pentamer Specific IgG
Time frame: Days 29, 85, 169, 197, and 347
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1647 in people with Cytomegalovirus Infection, run by ModernaTX, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Up to Day 176 (7 days after each injection)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.