InfluenzaPhase 1NCT03076385
Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects
A Phase 1 study testing VAL-506440 in people with Influenza, run by ModernaTX, Inc. at 1 site in Germany.
Trial summary
This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VAL-506440
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Oct 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 64 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 64 years of age
- Body mass index between 18 and 30 kg/m2
- Negative urine pregnancy test at the Screening visit and the day of each vaccination.
- Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination
- In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
Who cannot join
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Administration of an investigational product within 45 days
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study
- Prior administration of investigational agent using formulations similar to VAL-506440
- History of a serious reaction to prior influenza vaccinations
- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
Show all 23Show fewer
- Administration of any live attenuated vaccines within 4 weeks before enrollment, inactive vaccines within 2 weeks before enrollment, or plans to any vaccine within the vaccination period
- 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 bleeding risk or thromboembolic event or any related medical history
- Regular alcohol consumption > 3 units/day, or current user of any illicit drugs, or has a history of drug/alcohol abuse with 1 year of screening or has a positive urine drug/alcohol test at screening
- Persons employed in a capacity that involves handling poultry or wild birds
- Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies within 4 weeks before administration of the first vaccination, throughout the study
- Had major surgery or donation of blood or blood products within 4 weeks of dosing
- Current smoking of more than 10 cigarettes (or equivalent amount of tobacco) per day, and within 3 months prior to Screening
- Subject is an employee of the Sponsor or CRO involved in the study.
- Vulnerable subjects (e.g., a subject kept in detention).
- 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
- History of autoimmune disease
- Inadequate Liver Function as defined by AST, ALT, GGT, alkaline phosphatase and bilirubin > 1.5xULN
- Known allergy or history of anaphylaxis or other serious adverse reactions to any of the constituents of the study vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects
This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.
- Conditions
- Influenza
- Being tested
- VAL-506440, Placebo
- Keywords
- VAL-506440, H10N8 antigen mRNA, Influenza vaccine
- 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-506440Biological
Escalating dose levels
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| VAL-506440 | Experimental | Not described Receives: Biological: VAL-506440 |
| 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.
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug
Measured: Through 13 months of study participation
Secondary outcomes (2)
Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples
Measured: Through 13 months of study participation
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples
Measured: Through 13 months of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startDec 2015
- Primary completionOct 2018
- Study completionOct 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 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
- NCT03076385
- Sponsor's protocol ID
- VAL-506440-P101
- Other IDs
- 2015-003452-48, 2015
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2017
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03076385
- Acronym / sponsor ID
- VAL-506440-P101
- Conditions
- Influenza
- Keywords
- VAL-506440, H10N8 antigen mRNA, Influenza vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Mar 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-506440 in healthy adult subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAL-506440 | Experimental | Biological: VAL-506440 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agrees to comply with the study procedures and provides written informed consent
- 18 to 64 years of age
- Body mass index between 18 and 30 kg/m2
- Negative urine pregnancy test at the Screening visit and the day of each vaccination.
- Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination
Key exclusion criteria (23 listed)
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- Administration of an investigational product within 45 days
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study
- Prior administration of investigational agent using formulations similar to VAL-506440
- History of a serious reaction to prior influenza vaccinations
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-506440Escalating dose levels | Biological | VAL-506440 |
| Placebo | Other | Placebo |
Primary outcome
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug
Time frame: Through 13 months of study participation
2 secondary outcomes
Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples
Time frame: Through 13 months of study participation
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples
Time frame: Through 13 months of study participation
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 22 Apr 2022.
- 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-506440 in people with Influenza, run by ModernaTX, Inc. at 1 site in Germany.
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 6 inclusion and 23 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 22 Apr 2022. 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 Germany. 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?
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug (time frame: Through 13 months of study participation). 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 NCT03076385, 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 22 Apr 2022.