Back to resultsStudy of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Investigational RSV vaccine MV-012-968 (Dosage 1)
Investigational RSV vaccine MV-012-968 (Dosage 2)
Placebo
Investigational RSV vaccine MV-012-968 (Dosage 3)
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Live attenuated vaccine, Safety, Immunogenicity, Phase 1 clinical trial, Pediatric, Seropositive
Eligibility Criteria
Key Inclusion Criteria:
- Children aged 15-59 months
- Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
- Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
- Written informed consent provided by parent(s)/guardian(s)
Key Exclusion Criteria:
- Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
- Known or suspected immunodeficiency
- Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
- Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
- Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
- Receipt of an investigational RSV vaccine at any time
- Any other condition that, in the judgment of the investigator, would be a risk to participant's safety and/or may interfere with study procedures or interpretation of results
Sites / Locations
- Meridian Clinical Research
- Meridian Clinical Research
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
Dosage Group 1: RSV Vaccine Dosage 1
Dosage Group 1: Placebo
Dosage Group 2: RSV Vaccine Dosage 2
Dosage Group 2: Placebo
Dosage Group 3: RSV Vaccine Dosage 3
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1.
Participants in this arm will receive a single intranasal dose of placebo.
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2.
Participants in this arm will receive a single intranasal dose of placebo.
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3.
Outcomes
Primary Outcome Measures
Solicited adverse events (AEs)
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational 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 titers
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
Change in serum binding (RSV F-specific) antibody titers
Change in serum binding (RSV F-specific) antibody titers will be measured per participant.
Change in nasal mucosal binding (RSV F-specific) antibody titers
Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.
Potential vaccine virus shedding: frequency
Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.
Potential vaccine virus shedding: magnitude
If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall.
Potential vaccine virus shedding: duration
If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04444284
Brief Title
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
Official Title
A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (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
Yes
5. Study Description
Brief Summary
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Live attenuated vaccine, Safety, Immunogenicity, Phase 1 clinical trial, Pediatric, Seropositive
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.
Masking
Participant
Masking Description
The study is single-mask in 2 of the 3 dosage groups: study participants and their parent(s)/guardian(s) will not know their child's study assignment, whereas investigators, site staff, and site pharmacists will remain unmasked.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dosage Group 1: RSV Vaccine Dosage 1
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1.
Arm Title
Dosage Group 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a single intranasal dose of placebo.
Arm Title
Dosage Group 2: RSV Vaccine Dosage 2
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2.
Arm Title
Dosage Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a single intranasal dose of placebo.
Arm Title
Dosage Group 3: RSV Vaccine Dosage 3
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3.
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 1)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 2)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 3)
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 may occur after investigational 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
Full study duration, 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
Full study duration, an average of 6 months
Secondary Outcome Measure Information:
Title
Change in serum RSV-specific neutralizing antibody titers
Description
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
Time Frame
Baseline through Day 28, an average of six (6) weeks
Title
Change in serum binding (RSV F-specific) antibody titers
Description
Change in serum binding (RSV F-specific) antibody titers will be measured per participant.
Time Frame
Baseline through Day 28, an average of six (6) weeks
Title
Change in nasal mucosal binding (RSV F-specific) antibody titers
Description
Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.
Time Frame
Baseline through Day 28, an average of six (6) weeks
Title
Potential vaccine virus shedding: frequency
Description
Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.
Time Frame
Baseline through Day 28, an average of four (4) weeks
Title
Potential vaccine virus shedding: magnitude
Description
If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall.
Time Frame
Baseline through Day 28, an average of four (4) weeks
Title
Potential vaccine virus shedding: duration
Description
If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.
Time Frame
Baseline through Day 28, an average of four (4) weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Children aged 15-59 months
Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
Written informed consent provided by parent(s)/guardian(s)
Key Exclusion Criteria:
Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
Known or suspected immunodeficiency
Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
Receipt of an investigational RSV vaccine at any time
Any other condition that, in the judgment of the investigator, would be a risk to participant's safety and/or may interfere with study procedures or interpretation of results
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
Meridian Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
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
result
Learn more about this trial
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
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