Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
VAL-506440
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring VAL-506440, H10N8 antigen mRNA, Influenza vaccine
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VAL-506440
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug
Secondary Outcome Measures
Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03076385
Brief Title
Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
VAL-506440, H10N8 antigen mRNA, Influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAL-506440
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
VAL-506440
Intervention Description
Escalating dose levels
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples
Time Frame
Through 13 months of study participation
Title
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples
Time Frame
Through 13 months of study participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion
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
Exclusion
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
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
Facility Information:
City
Berlin
Country
Germany
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-506440 in Healthy Adult Subjects
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