Human Metapneumovirus and Human Parainfluenza InfectionPhase 1NCT03392389
Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults
A Phase 1 study testing mRNA-1653 in people with Human Metapneumovirus and Human Parainfluenza Infection, run by ModernaTX, Inc. at 3 sites in United States.
Trial summary
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine 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
- Human Metapneumovirus and Human Parainfluenza Infection
- What is being tested?
- mRNA-1653
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Dec 2017to 29 Jul 2019
- 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
- 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
- Donation of blood or blood products > 450 mL within 30 days of dosing.
- Is an immediate family member or household member of study personnel
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Benchmark Research
Austin, Texas, 78705
Benchmark Research
Fort Worth, Texas, 76135
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
About this study
Official title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus and Human Parainfluenza Virus Type 3 Vaccine, When Administered to Healthy Adults
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy adults.
- Being tested
- mRNA-1653, Placebo
- Keywords
- mRNA-1653, human metapneumovirus, human parainfluenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1653Biological
Escalating dose levels
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1653 | Experimental | Not described Receives: Biological: mRNA-1653 |
| 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: 28 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs
Measured: one year following the last dose administration
Frequency of clinical laboratory adverse events
Measured: 1 month following the last dose administration
Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies
Measured: 1 month following the last dose administration
Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination
Measured: 1 month following the last dose administration
Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline
Measured: 1 month following the last dose administration
Secondary outcomes (3)
Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies
Measured: 6 months and 1 year following the last dose administration
Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination
Measured: 6 months and 1 year following the last dose administration
Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline
Measured: 6 months and 1 year 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 posted8 Jan 2018
- Study start4 Dec 2017
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 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
- NCT03392389
- Sponsor's protocol ID
- mRNA-1653-P101
- Status last verified
- Feb 2020
- First submitted
- 2 Jan 2018
- Last updated
- 6 Feb 2020
- 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 6 Feb 2020. 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 mRNA-1653, a Combined Human Metapneumovirus and Human Parainfluenza Virus Type 3 Vaccine, When Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT03392389
- Acronym / sponsor ID
- mRNA-1653-P101
- Keywords
- mRNA-1653, human metapneumovirus, human parainfluenza vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 8 Jan 2018 (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-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-1653 | Experimental | Biological: mRNA-1653 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 (20 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-1653Escalating dose levels | Biological | mRNA-1653 |
| 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: 28 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs
Time frame: one year following the last dose administration
Frequency of clinical laboratory adverse events
Time frame: 1 month following the last dose administration
Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies
Time frame: 1 month following the last dose administration
Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination
Time frame: 1 month following the last dose administration
Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline
Time frame: 1 month following the last dose administration
3 secondary outcomes
Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies
Time frame: 6 months and 1 year following the last dose administration
Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination
Time frame: 6 months and 1 year following the last dose administration
Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline
Time frame: 6 months and 1 year 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 6 Feb 2020.
- 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.
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-1653 in people with Human Metapneumovirus and Human Parainfluenza 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 7 inclusion and 20 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 6 Feb 2020. 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?
Frequency of solicited AEs (local and systemic reactogenicity events) (time frame: 7 days following each dose administration). The study lists 7 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 6 Feb 2020.