Human Metapneumovirus and Human Parainfluenza InfectionPhase 1NCT04144348
Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
A Phase 1 study testing mRNA-1653 in people with Human Metapneumovirus and Human Parainfluenza Infection, run by ModernaTX, Inc. at 19 sites in United States.
Trial summary
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. Read more about this study
- Who is it for?
- Ages 12 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Metapneumovirus and Human Parainfluenza Infection
- What is being tested?
- mRNA-1653
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 19 sitesUnited States
- Study dates
- 4 Nov 2019to 20 Dec 2022
- 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 12 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults 18 to 49 years of age and children 12 to 59 months of age at the time of consent who, in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination
- Adult participant or parent(s)/legal guardian(s) has provided written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol
- Screening laboratory values Grade ≤1
- Specific inclusion criteria for adults 18 to 49 years of age:
- Body mass index (BMI) from ≥18 kg/m^2 and ≤35 kg/m^2
- Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding
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- Specific inclusion criteria for children 12 to 59 months of age:
- Seropositive for both hMPV and PIV3 neutralizing antibody at Screening
- Has received routine immunizations appropriate for age per the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP)
- Current height and weight above the third percentile for age
Who cannot join
- Adult and pediatric participants eligible for this study must not meet any of the following criteria:
- Acutely ill or febrile (temperature ≥38.0℃/100.4°F, regardless of route) on the day of the first vaccination
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Receipt of, or plans for receipt of an inactivated vaccine(s) 14 days prior to though 14 days following each study injection or a live virus vaccine(s) within 28 days prior to, or plans to through 28 days following each study injection. The exception is any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
- Any chronic administration of an immunosuppressant or other immune modifying drug
- Prior administration of investigational agent using lipid nanoparticle formulations
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- Donation of blood or blood products ≥450 mL within 28 days of the Screening visit (for the Adult Cohort)
- Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
- Participated in an interventional clinical trial within 28 days prior to the day of enrollment, or plans to do so while enrolled in this trial
- Has a family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
UHS Primary Care
Binghamton, New York, 13901
Central Research Associates Inc
Birmingham, Alabama, 35205
Crossroads Clinical Research
Corpus Christi, Texas, 78413
Ohio Pediatric Research Assn Inc
Dayton, Ohio, 45414
Duke Vaccine and Trials Unit
Durham, North Carolina, 27710
Heartland Research Associates LLC
El Dorado, Kansas, 67042
University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555
Clinical Research Prime
Idaho Falls, Idaho, 83404
Tanner Clinic
Layton, Utah, 84041
Meridian Clinical Research, LLC
Lincoln, Nebraska, 68510
Child Healthcare Associates
Liverpool, New York, 13090
MedPharmics
Metairie, Louisiana, 70006
Heartland Research Associates LLC
Newton, Kansas, 67114
Meridian Clinical Research
Norfolk, Nebraska, 68701
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Tekton Research Inc
San Antonio, Texas, 78240
Sanford Children's Hospital
Sioux Falls, South Dakota, 57117
Child Healthcare Assoc.
Syracuse, New York, 13057
Meridian Clinical Research
Washington D.C., District of Columbia, 20016
About this study
Official title: A Phase 1b, Randomized, Observer-Blind, Placebo-Controlled, Dose Ranging Trial to Evaluate the Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine When Administered to Adults, and to Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.
- Being tested
- mRNA-1653, Placebo
- Keywords
- ModernaTX, mRNA-1653, human metapneumovirus, human parainfluenza, human parainfluenza vaccine, virus diseases, RNA virus infections, paramyxoviridae infections, mononegavirales infections
- Medical subject headings
- Virus Diseases, RNA Virus Infections, Paramyxoviridae Infections, Mononegavirales Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1653Biological
Sterile liquid for injection
PlaceboBiological
Also called saline
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1653, Adult participants | Experimental | Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57. Receives: Biological: mRNA-1653 |
| mRNA-1653 Pediatric participants | Experimental | Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57. Receives: Biological: mRNA-1653 |
| Placebo, Adult participants | Placebo comparator | Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57. Receives: Biological: Placebo |
| Placebo, Pediatric participants | Placebo comparator | Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to 7 days after each dose administration
Proportion of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to 28 days after each dose administration
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
Measured: Up to 1 year after the last dose administration
Secondary outcomes (3)
Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Measured: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Measured: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline
Measured: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start4 Nov 2019
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Metapneumovirus and Human Parainfluenza 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
- Sequential
- Model description
- Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 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
- NCT04144348
- Sponsor's protocol ID
- mRNA-1653-P102
- Status last verified
- Jan 2023
- First submitted
- 28 Oct 2019
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Observer-Blind, Placebo-Controlled, Dose Ranging Trial to Evaluate the Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine When Administered to Adults, and to Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
- ClinicalTrials.gov ID
- NCT04144348
- Acronym / sponsor ID
- mRNA-1653-P102
- Keywords
- ModernaTX, mRNA-1653, human metapneumovirus, human parainfluenza, human parainfluenza vaccine, virus diseases, RNA virus infections, paramyxoviridae infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 30 Oct 2019 (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 and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
| Arm | Type | Receives |
|---|---|---|
| mRNA-1653, Adult participants | Experimental | Biological: mRNA-1653Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57. |
| mRNA-1653 Pediatric participants | Experimental | Biological: mRNA-1653Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57. |
| Placebo, Adult participants | Placebo comparator | Biological: PlaceboParticipants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57. |
| Placebo, Pediatric participants | Placebo comparator | Biological: PlaceboParticipants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57. |
Who may qualify
- Ages
- 12 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Adults 18 to 49 years of age and children 12 to 59 months of age at the time of consent who, in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination
- Adult participant or parent(s)/legal guardian(s) has provided written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol
- Screening laboratory values Grade ≤1
- Body mass index (BMI) from ≥18 kg/m^2 and ≤35 kg/m^2
- Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding
Key exclusion criteria (10 listed)
- Adult and pediatric participants eligible for this study must not meet any of the following criteria:
- Acutely ill or febrile (temperature ≥38.0℃/100.4°F, regardless of route) on the day of the first vaccination
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Receipt of, or plans for receipt of an inactivated vaccine(s) 14 days prior to though 14 days following each study injection or a live virus vaccine(s) within 28 days prior to, or plans to through 28 days following each study injection. The exception is any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
- Any chronic administration of an immunosuppressant or other immune modifying drug
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-1653Sterile liquid for injection | Biological | mRNA-1653 Pediatric participants, mRNA-1653, Adult participants |
| PlaceboAlso: salineSterile liquid for injection | Biological | Placebo, Adult participants, Placebo, Pediatric participants |
Primary outcome
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to 7 days after each dose administration
Proportion of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to 28 days after each dose administration
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
Time frame: Up to 1 year after the last dose administration
3 secondary outcomes
Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Time frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Time frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline
Time frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
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 3 Feb 2023.
- 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.
19 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-1653 in people with Human Metapneumovirus and Human Parainfluenza Infection, run by ModernaTX, Inc. at 19 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 10 inclusion and 10 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Up to 7 days after each dose administration). The study lists 3 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 3 Feb 2023.