Cytomegalovirus InfectionPhase 1NCT03382405
Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
A Phase 1 study testing mRNA-1647 and mRNA-1443 in people with Cytomegalovirus Infection, run by ModernaTX, Inc. at 4 sites in United States.
Trial summary
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- mRNA-1647 and mRNA-1443
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Nov 2017to 28 Oct 2020
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agrees to comply with the study procedures and provides written informed consent
- 18 to 49 years of age
- Body mass index between 18 and 35 kg/m2
- In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
- Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential
- Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 30 days prior to enrollment and through 3 months following last vaccination
- Male subjects must agree to practice adequate contraception for 30 days prior to the first vaccination and through 3 months following the last vaccination
- Willing to comply with the requirements of the protocol (eg, complete Diary Cards, return for follow-up visits, be available for safety phone calls)
Who cannot join
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- A history of malignancy in the last 10 years
- If female and of childbearing potential, is pregnant or lactating, has not adhered to an adequate contraception method from at least 30 days before study entry, or does not plan to do so for at least 3 months after the last vaccination.
- Abnormal screening safety laboratory test results including liver enzyme tests
- Administration of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine or has plans for administration during the study period
- Prior administration of investigational agent using lipid nanoparticle formulations
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- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
- A positive test result for drugs of abuse
- Chronic administration of potentially hepatotoxic drugs or have other medical conditions that affect the liver (eg, alcohol abuse)
- A history of idiopathic urticaria
- Plans for administration or has been administered a vaccine within the period from 30 days before through 30 days after each study vaccination, with the exception of any licensed influenza vaccine administered ≥15 days before or after any study vaccination
- Any chronic administration of an immunosuppressant or other immune modifying drug
- Prior administration of immunoglobulins and/or any blood products within the 3 months before the first study vaccine or has plans for administration during the study period
- Any known or suspected immune-mediated disease or immunosuppressive condition as determined by medical history and/or physical examination
- A history of hypersensitivity or serious reactions to previous vaccinations
- Any bleeding disorder considered a contraindication to IM injection or blood draw
- Any acute illness or fever at screening
- Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study drug or interpretation of study results
- Dose-escalation phase only, is seropositive for CMV at the Screening visit
- Donation of blood or blood products > 450 mL within 30 days of dosing.
- Is an immediate family member or household member of study personnel
- A history of seizure disorder for which anticonvulsants are currently prescribed
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Centers of America
Hollywood, Florida, 33024
Johnson County Clinical Trials
Lenexa, Kansas, 66219
Advanced Clinical Research
Meridian, Idaho, 83642
Optimal Research
Peoria, Illinois, 61614
About this study
Official title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
- Conditions
- Cytomegalovirus Infection
- Being tested
- mRNA-1647, mRNA-1443, Placebo
- Keywords
- cytomegalovirus vaccine, mRNA-1647, mRNA-1443, Moderna
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1647Biological
Escalating dose levels
mRNA-1443Biological
Escalating dose levels
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1647 | Experimental | Not described Receives: Biological: mRNA-1647 |
| mRNA-1443 | Experimental | Not described Receives: Biological: mRNA-1443 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited AEs (local and systemic reactogenicity events)
Measured: 7 days following each dose administration
Frequency of unsolicited adverse events
Measured: 29 days following each dose administration
Frequency of medically-attended AEs, adverse events of special interest (AESI), and serious adverse events (SAE)
Measured: one year following the last dose administration
Frequency of clinical laboratory adverse events
Measured: 1 month following the last dose administration
Secondary outcomes (4)
Titers of anti-CMV neutralizing antibodies against epithelial cell infection measured by neutralization assay in comparison with baseline sample
Measured: 6 months following the last dose administration
Titers of anti-CMV neutralizing antibodies against fibroblast cell infection measured by neutralization assay in comparison with baseline sample
Measured: 6 months following the last dose administration
Titers of vaccine antigen-specific IgG antibodies as measured by ELISA assay in comparison with baseline sample
Measured: 6 months following the last dose administration
Frequencies of vaccine antigen-specific CD4 and CD8 T cells secreting interferon gamma as determined by ELISPOT
Measured: 6 months following the last dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start13 Nov 2017
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 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
- NCT03382405
- Sponsor's protocol ID
- mRNA-1647/mRNA-1443-P101
- Status last verified
- Jan 2021
- First submitted
- 6 Dec 2017
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu K, Hou YJ, Makrinos D, Liu R, Zhu A, Koch M, Yu W-H, Paila YD, Chandramouli S, Panther L, Henry C, DiPiazza A, Carfi A. Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. J Virol. 2024 Apr 16;98(4):e0160323. doi: 10.1128/jvi.01603-23. Epub 2024 Mar 25.
PubMed 38526054Fierro C, Brune D, Shaw M, Schwartz H, Knightly C, Lin J, Carfi A, Natenshon A, Kalidindi S, Reuter C, Miller J, Panther L. Safety and Immunogenicity of a Messenger RNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1 Randomized Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e668-e678. doi: 10.1093/infdis/jiae114.
PubMed 38478705Hu X, Karthigeyan KP, Herbek S, Valencia SM, Jenks JA, Webster H, Miller IG, Connors M, Pollara J, Andy C, Gerber LM, Walter EB, Edwards KM, Bernstein DI, Hou J, Koch M, Panther L, Carfi A, Wu K, Permar SR. Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine. J Infect Dis. 2024 Aug 16;230(2):455-466. doi: 10.1093/infdis/jiad593.
PubMed 38324766
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT03382405
- Acronym / sponsor ID
- mRNA-1647/mRNA-1443-P101
- Conditions
- Cytomegalovirus Infection
- Keywords
- cytomegalovirus vaccine, mRNA-1647, mRNA-1443, Moderna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 22 Dec 2017 (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.
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mRNA-1647 | Experimental | Biological: mRNA-1647 |
| mRNA-1443 | Experimental | Biological: mRNA-1443 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Agrees to comply with the study procedures and provides written informed consent
- 18 to 49 years of age
- Body mass index between 18 and 35 kg/m2
- In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
- Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential
Key exclusion criteria (22 listed)
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- A history of malignancy in the last 10 years
- If female and of childbearing potential, is pregnant or lactating, has not adhered to an adequate contraception method from at least 30 days before study entry, or does not plan to do so for at least 3 months after the last vaccination.
- Abnormal screening safety laboratory test results including liver enzyme tests
- Administration of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine or has plans for administration during the study period
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-1647Escalating dose levels | Biological | mRNA-1647 |
| mRNA-1443Escalating dose levels | Biological | mRNA-1443 |
| PlaceboSaline | Other | Placebo |
Primary outcome
Frequency of solicited AEs (local and systemic reactogenicity events)
Time frame: 7 days following each dose administration
Frequency of unsolicited adverse events
Time frame: 29 days following each dose administration
Frequency of medically-attended AEs, adverse events of special interest (AESI), and serious adverse events (SAE)
Time frame: one year following the last dose administration
Frequency of clinical laboratory adverse events
Time frame: 1 month following the last dose administration
4 secondary outcomes
Titers of anti-CMV neutralizing antibodies against epithelial cell infection measured by neutralization assay in comparison with baseline sample
Time frame: 6 months following the last dose administration
Titers of anti-CMV neutralizing antibodies against fibroblast cell infection measured by neutralization assay in comparison with baseline sample
Time frame: 6 months following the last dose administration
Titers of vaccine antigen-specific IgG antibodies as measured by ELISA assay in comparison with baseline sample
Time frame: 6 months following the last dose administration
Frequencies of vaccine antigen-specific CD4 and CD8 T cells secreting interferon gamma as determined by ELISPOT
Time frame: 6 months following the last dose administration
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 15 Jan 2021.
- Derived from this study: PubMed 38526054Wu K, Hou YJ, Makrinos D, Liu R, Zhu A, Koch M, Yu W-H, Paila YD, Chandramouli S, Panther L, Henry C, DiPiazza A, Carfi A. Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. J Virol. 2024 Apr 16;98(4):e0160323. doi: 10.1128/jvi.01603-23. Epub 2024 Mar 25.
- Derived from this study: PubMed 38478705Fierro C, Brune D, Shaw M, Schwartz H, Knightly C, Lin J, Carfi A, Natenshon A, Kalidindi S, Reuter C, Miller J, Panther L. Safety and Immunogenicity of a Messenger RNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1 Randomized Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e668-e678. doi: 10.1093/infdis/jiae114.
- Derived from this study: PubMed 38324766Hu X, Karthigeyan KP, Herbek S, Valencia SM, Jenks JA, Webster H, Miller IG, Connors M, Pollara J, Andy C, Gerber LM, Walter EB, Edwards KM, Bernstein DI, Hou J, Koch M, Panther L, Carfi A, Wu K, Permar SR. Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine. J Infect Dis. 2024 Aug 16;230(2):455-466. doi: 10.1093/infdis/jiad593.
- Individual participant dataSharing planned: No
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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.
4 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 and mRNA-1443 in people with Cytomegalovirus Infection, run by ModernaTX, Inc. at 4 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 8 inclusion and 22 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Frequency of solicited AEs (local and systemic reactogenicity events) (time frame: 7 days following each dose administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382405, which also lists 3 linked publications.
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 15 Jan 2021.