Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VAL-339851
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring VAL-339851, H7N9 antigen mRNA, Influenza vaccine, Moderna
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Miami Research Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VAL-339851
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Frequency of solicited AEs (local and systemic reactogenicity events)
Frequency of unsolicited adverse events
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
Secondary Outcome Measures
Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
Seroconversion rates in comparison to baseline samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03345043
Brief Title
Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
VAL-339851, H7N9 antigen mRNA, Influenza vaccine, Moderna
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAL-339851
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
VAL-339851
Intervention Description
Escalating dose levels
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Frequency of solicited AEs (local and systemic reactogenicity events)
Time Frame
7 days following each dose administration
Title
Frequency of unsolicited adverse events
Time Frame
21 days following each dose administration
Title
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
Secondary Outcome Measure Information:
Title
Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
Time Frame
One year after last dose administration
Title
Seroconversion rates in comparison to baseline samples
Time Frame
One year after last dose administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31079849
Citation
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.
Results Reference
derived
Learn more about this trial
Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects
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