InfluenzaPhase 1NCT03345043
Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects
A Phase 1 study testing VAL-339851 in people with Influenza, run by ModernaTX, Inc. at 1 site in United States.
Trial summary
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VAL-339851
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2016to 13 Aug 2018
- 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
- 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 3 weeks prior to enrollment and through the end of study visit
- In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
- Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study
Who cannot join
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Administration of another investigational product within 60 days, or 5 half-lives, whichever is longer
- Participation in an investigational study involving lipid nanoparticles
- A history of hypersensitivity or serious reactions to previous influenza vaccinations
- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
- History of narcolepsy
Show all 20Show fewer
- Administration of any licensed (inactivated or live) vaccines within 4 weeks before enrollment or plans to receive any vaccine within 12 weeks of the last study drug administration; receipt of any other avian H7N9 influenza vaccine at any time prior to or during the study is exclusionary
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- Any chronic administration of immunosuppressant or other immune-modifying drugs within 6 months prior to administration of study vaccine
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Any acute disease at the time of enrollment
- Any significant disorder of coagulation requiring ongoing or intermittent treatment
- Active neoplastic disease or a history of any hematologic malignancy
- History of alcohol abuse or drug addiction within 1 year before the planned day of dose administration
- A positive test result for drugs of abuse or alcohol at screening or before the first dose administration
- Persons employed in a capacity that involves handling poultry or wild birds.
- The subject has any abnormality or permanent body art (eg, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
- 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 vaccine or interpretation of the study results
- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening
- Donation of blood or blood products > 450 mL within 30 days of dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VAL-339851 in Healthy Subjects
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
- Conditions
- Influenza
- Being tested
- VAL-339851, Placebo
- Keywords
- VAL-339851, H7N9 antigen mRNA, Influenza vaccine, Moderna
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAL-339851Biological
Escalating dose levels
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| VAL-339851 | Experimental | Not described Receives: Biological: VAL-339851 |
| 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: 21 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
Measured: One year after last dose administration
Secondary outcomes (2)
Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
Measured: One year after last dose administration
Seroconversion rates in comparison to baseline samples
Measured: One year after 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 posted17 Nov 2017
- Study start11 May 2016
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 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
- NCT03345043
- Sponsor's protocol ID
- VAL-339851-P101
- Status last verified
- Jan 2021
- First submitted
- 14 Nov 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldman RA, Fuhr R, Smolenov I, Mick Ribeiro A, Panther L, Watson M, Senn JJ, Smith M, Almarsson Ӧ, Pujar HS, Laska ME, Thompson J, Zaks T, Ciaramella G. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine. 2019 May 31;37(25):3326-3334. doi: 10.1016/j.vaccine.2019.04.074. Epub 2019 May 10.
PubMed 31079849
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VAL-339851 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03345043
- Acronym / sponsor ID
- VAL-339851-P101
- Conditions
- Influenza
- Keywords
- VAL-339851, H7N9 antigen mRNA, Influenza vaccine, Moderna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 17 Nov 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, tolerability and immunogenicity of VAL-339851 in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAL-339851 | Experimental | Biological: VAL-339851 |
| 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
- 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 3 weeks prior to enrollment and through the end of study visit
Key exclusion criteria (20 listed)
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Administration of another investigational product within 60 days, or 5 half-lives, whichever is longer
- Participation in an investigational study involving lipid nanoparticles
- A history of hypersensitivity or serious reactions to previous influenza vaccinations
- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
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 |
|---|---|---|
| VAL-339851Escalating dose levels | Biological | VAL-339851 |
| 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: 21 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
Time frame: One year after last dose administration
2 secondary outcomes
Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
Time frame: One year after last dose administration
Seroconversion rates in comparison to baseline samples
Time frame: One year after 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 11 Jan 2021.
- Derived from this study: PubMed 31079849Feldman RA, Fuhr R, Smolenov I, Mick Ribeiro A, Panther L, Watson M, Senn JJ, Smith M, Almarsson Ӧ, Pujar HS, Laska ME, Thompson J, Zaks T, Ciaramella G. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine. 2019 May 31;37(25):3326-3334. doi: 10.1016/j.vaccine.2019.04.074. Epub 2019 May 10.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VAL-339851 in people with Influenza, run by ModernaTX, Inc. at 1 site 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 11 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 1 site 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 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?
On the ClinicalTrials.gov record for NCT03345043, which also lists 1 linked publication.
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 Jan 2021.