Back to resultsSafety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
Primary Purpose
Covid19
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, adult
Eligibility Criteria
Inclusion Criteria:
- Healthy adults ≥18 and <56 years (Cohort A) and ≥56 years and <70 years (Cohort B) as determined at the day of signing informed consent
- SARS-CoV-2 RT-PCR (nasal swab) negative at Day 1 pre-dose
- Women of childbearing potential (WOCBP) or male subjects with partners who are WOCBP must agree to practice contraception during their study participation from the signing of informed consent for at least 3 months after the final MV-014-212 administration.
- Written informed consent
Exclusion Criteria:
- Diagnosis of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, pulmonary fibrosis, cystic fibrosis). Resolved childhood asthma is not exclusionary.
- Immunocompromised state due to comorbidities or other conditions as detailed in the study protocol
- Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
- Receipt of any other SARS-CoV-2, other experimental coronavirus, or experimental RSV vaccine at any time prior to the study
- Healthcare worker, long-term care or nursing home facility resident or employee, member of an emergency response team, or other occupation with high risk of exposure to SARS-CoV-2, and those working outside the home in customer facing occupations (e.g. waiter, cashier or store clerk, public transportation or taxi driver)
- Positive serum pregnancy test during Screening and/or positive urine pregnancy test on Day 1
- Breastfeeding during any period of study participation
- Occupational or household exposure to children <5 years of age or to immunocompromised persons
- Receipt of or scheduled to receive any other SARS-CoV-2 vaccine prior to Day 1. Once dosed with MV-014-212, subjects should not receive an authorized or approved COVID-19 vaccine until after the Day 57 visit (single-dose subjects) or the Day 92 visit (two-dose subjects)
- Any medical disease or condition that, in the opinion of the PI, precludes study participation. This includes acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial
Sites / Locations
- Johnson County Clin-TrialsRecruiting
- Wake ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A / Dosage Group 1 (intranasal drops) / Single Dose
Cohort A / Dosage Group 2 (intranasal drops) / Single Dose
Cohort A / Dosage Group 3a (intranasal drops) / Single Dose
Cohort A / Dosage Group 3a (intranasal drops) / Two Doses
Cohort A / Dosage Group 3b (intranasal spray) / Single Dose
Cohort B / Dosage Group 4 (intranasal drops) / Single Dose
Cohort B / Dosage Group 5 (intranasal drops) / Single Dose
Cohort B / Dosage Group 6 (intranasal drops) / Single Dose
Arm Description
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 1 in the form of intranasal drops on Day 1.
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 2 in the form of intranasal drops on Day 1.
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1.
Participants in this arm (18-55 years) will receive an intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1. These participants will receive a second, identical dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 36.
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of a nasal spray on Day 1.
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 1 in the form of intranasal drops on Day 1.
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 2 in the form of intranasal drops on Day 1.
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1.
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.
Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein
Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Secondary Outcome Measures
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein 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
NCT04798001
Brief Title
Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
Official Title
Phase 1, Open-Label, Dose-Escalation Study to Evaluate Tolerability, Safety, and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine Expressing Spike Protein of SARS-CoV-2 in Healthy Adults Ages 18 - 69 Years
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
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 SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, adult
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This study evaluates 3 dosages of MV-014-212 in healthy adults.
Cohort A (18-55 years, inclusive) enrolls first. 10 participants (Group 1) receive Dosage 1. 20 participants (Group 2) receive Dosage 2. 50 participants (Group 3) receive Dosage 3: (i) 20 participants (Group 3a) receive a single dose; (ii) 10 participants (Group 3a) receive a 1st dose followed 2nd dose approx. 35 days after the 1st dose; (iii) 20 participants (Group 3b) receive a single dose by nasal atomizer (spray).
After review of Cohort A safety data, Cohort B (56-69 years, inclusive) enrolls. Sequential enrollment into Group 4 (10 participants; Dosage 1), Group 5 (20 participants; Dosage 2), then Group 6 (20 participants; Dosage 3) is based in each case on the preceding safety data review, as for Cohort A.
Within each group, a sentinel dosing approach is implemented as an added safety measure.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A / Dosage Group 1 (intranasal drops) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 1 in the form of intranasal drops on Day 1.
Arm Title
Cohort A / Dosage Group 2 (intranasal drops) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 2 in the form of intranasal drops on Day 1.
Arm Title
Cohort A / Dosage Group 3a (intranasal drops) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1.
Arm Title
Cohort A / Dosage Group 3a (intranasal drops) / Two Doses
Arm Type
Experimental
Arm Description
Participants in this arm (18-55 years) will receive an intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1. These participants will receive a second, identical dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 36.
Arm Title
Cohort A / Dosage Group 3b (intranasal spray) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (18-55 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of a nasal spray on Day 1.
Arm Title
Cohort B / Dosage Group 4 (intranasal drops) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 1 in the form of intranasal drops on Day 1.
Arm Title
Cohort B / Dosage Group 5 (intranasal drops) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 2 in the form of intranasal drops on Day 1.
Arm Title
Cohort B / Dosage Group 6 (intranasal drops) / Single Dose
Arm Type
Experimental
Arm Description
Participants in this arm (56-69 years) will receive a single intranasal dose of the MV-014-212 vaccine at Dosage 3 in the form of intranasal drops on Day 1.
Intervention Type
Biological
Intervention Name(s)
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops
Intervention Description
Single intranasal dose on Day 1, by intranasal drops
Intervention Type
Biological
Intervention Name(s)
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops
Intervention Description
Single intranasal dose on Day 1, by intranasal drops
Intervention Type
Biological
Intervention Name(s)
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops
Intervention Description
Single intranasal dose on Day 1, by intranasal drops
Intervention Type
Biological
Intervention Name(s)
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops
Intervention Description
Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day 36 by intranasal drops
Intervention Type
Biological
Intervention Name(s)
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray
Intervention Description
Single intranasal dose on Day 1, by intranasal spray
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 1 year
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 1 year
Title
Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein
Description
Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Time Frame
Baseline through Day 29, an average of five (5) weeks
Secondary Outcome Measure Information:
Title
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
Description
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Time Frame
Baseline through Day 29, an average of five (5) 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 29, 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 29, 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 29, an average of four (4) weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults ≥18 and <56 years (Cohort A) and ≥56 years and <70 years (Cohort B) as determined at the day of signing informed consent
SARS-CoV-2 RT-PCR (nasal swab) negative at Day 1 pre-dose
Women of childbearing potential (WOCBP) or male subjects with partners who are WOCBP must agree to practice contraception during their study participation from the signing of informed consent for at least 3 months after the final MV-014-212 administration.
Written informed consent
Exclusion Criteria:
Diagnosis of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, pulmonary fibrosis, cystic fibrosis). Resolved childhood asthma is not exclusionary.
Immunocompromised state due to comorbidities or other conditions as detailed in the study protocol
Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
Receipt of any other SARS-CoV-2, other experimental coronavirus, or experimental RSV vaccine at any time prior to the study
Healthcare worker, long-term care or nursing home facility resident or employee, member of an emergency response team, or other occupation with high risk of exposure to SARS-CoV-2, and those working outside the home in customer facing occupations (e.g. waiter, cashier or store clerk, public transportation or taxi driver)
Positive serum pregnancy test during Screening and/or positive urine pregnancy test on Day 1
Breastfeeding during any period of study participation
Occupational or household exposure to children <5 years of age or to immunocompromised persons
Receipt of or scheduled to receive any other SARS-CoV-2 vaccine prior to Day 1. Once dosed with MV-014-212, subjects should not receive an authorized or approved COVID-19 vaccine until after the Day 57 visit (single-dose subjects) or the Day 92 visit (two-dose subjects)
Any medical disease or condition that, in the opinion of the PI, precludes study participation. This includes acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Lieberman, MD
Phone
3107538943
Email
jay.lieberman@meissavaccines.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Lieberman, MD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mazen Zari, MS.cs, RRT
Phone
913-825-4400
Email
mzari@jcct.com
First Name & Middle Initial & Last Name & Degree
Carlos Fierro, MD
Facility Name
Wake Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makayla Dutton
Email
mdutton@wakeresearch.com
First Name & Middle Initial & Last Name & Degree
Lisa M Cohen, DO
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 Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
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