Back to resultsSafety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RSV vaccine MV-012-968 (dosage #1)
RSV vaccine MV-012-968 (dosage #2)
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring vaccine, live attenuated, safety, immunogenicity, viral shedding, phase 1 clinical trial
Eligibility Criteria
Key Inclusion Criteria:
- Adult 18-40 years of age
- In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
- RSV 'sero-low' from a pre-vaccination serum sample
- Signed informed consent form
Exclusion Criteria:
- Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals
- Prior receipt of an investigational RSV vaccine
- Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
- Any other reason the Investigator considers exclusionary
Sites / Locations
- Johnson County Clin-Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RSV Vaccine: Dosage Group #1
RSV Vaccine: Dosage Group #2
Arm Description
Participants in this group will receive a single dose of the RSV vaccine at dosage #1
Participants in this group will receive a single dose of the RSV vaccine at dosage #2
Outcomes
Primary Outcome Measures
Solicited adverse events (AEs)
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration.
Unsolicited AEs
Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.
Serious adverse events (SAEs)
Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Medically attended adverse events (MAEs)
Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.
Secondary Outcome Measures
Change in serum RSV-specific neutralizing antibody (nAb) titers
Post-vaccination change in serum RSV-specific nAb titers will be measured per participant.
Change in serum RSV F-specific binding antibody titers
Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant.
Change in mucosal RSV F-specific binding antibody titers
Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant.
Potential vaccine virus shedding
The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant.
Full Information
NCT ID
NCT04227210
First Posted
January 6, 2020
Last Updated
September 13, 2020
Sponsor
Meissa Vaccines, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04227210
Brief Title
Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
Official Title
A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meissa Vaccines, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
vaccine, live attenuated, safety, immunogenicity, viral shedding, phase 1 clinical trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RSV Vaccine: Dosage Group #1
Arm Type
Experimental
Arm Description
Participants in this group will receive a single dose of the RSV vaccine at dosage #1
Arm Title
RSV Vaccine: Dosage Group #2
Arm Type
Experimental
Arm Description
Participants in this group will receive a single dose of the RSV vaccine at dosage #2
Intervention Type
Biological
Intervention Name(s)
RSV vaccine MV-012-968 (dosage #1)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Biological
Intervention Name(s)
RSV vaccine MV-012-968 (dosage #2)
Intervention Description
Single dose administered intranasally on Day 1
Primary Outcome Measure Information:
Title
Solicited adverse events (AEs)
Description
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration.
Time Frame
Immediate post-vaccination period
Title
Unsolicited AEs
Description
Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine.
Time Frame
Immediate post-vaccination period
Title
Serious adverse events (SAEs)
Description
Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Time Frame
Vaccination through study completion, an average of 6 months
Title
Medically attended adverse events (MAEs)
Description
Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs.
Time Frame
Vaccination through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Change in serum RSV-specific neutralizing antibody (nAb) titers
Description
Post-vaccination change in serum RSV-specific nAb titers will be measured per participant.
Time Frame
Baseline through study completion, an average of 6 months
Title
Change in serum RSV F-specific binding antibody titers
Description
Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant.
Time Frame
Baseline through study completion, an average of 6 months
Title
Change in mucosal RSV F-specific binding antibody titers
Description
Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant.
Time Frame
Baseline through study completion, an average of 6 months
Title
Potential vaccine virus shedding
Description
The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant.
Time Frame
Baseline through 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Adult 18-40 years of age
In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
RSV 'sero-low' from a pre-vaccination serum sample
Signed informed consent form
Exclusion Criteria:
Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals
Prior receipt of an investigational RSV vaccine
Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination
Any other reason the Investigator considers exclusionary
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Medzihradsky, MD MPH MS
Organizational Affiliation
Meissa Vaccines, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28000669
Citation
Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916.
Results Reference
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Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
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