Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults
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
1 other identifier
interventional
130
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Apr 2021
Longer than P75 for phase_1 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedAugust 2, 2022
August 1, 2022
1.6 years
March 9, 2021
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Immediate post-vaccination period
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.
Immediate post-vaccination period
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.
Full study duration, an average of 1 year
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.
Full study duration, an average of 1 year
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
Baseline through Day 29, an average of five (5) weeks
Secondary Outcomes (4)
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
Baseline through Day 29, an average of five (5) weeks
Potential vaccine virus shedding: frequency
Baseline through Day 29, an average of four (4) weeks
Potential vaccine virus shedding: magnitude
Baseline through Day 29, an average of four (4) weeks
Potential vaccine virus shedding: duration
Baseline through Day 29, an average of four (4) weeks
Study Arms (8)
Cohort A / Dosage Group 1 (intranasal drops) / Single Dose
EXPERIMENTALParticipants 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.
Cohort A / Dosage Group 2 (intranasal drops) / Single Dose
EXPERIMENTALParticipants 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.
Cohort A / Dosage Group 3a (intranasal drops) / Single Dose
EXPERIMENTALParticipants 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.
Cohort A / Dosage Group 3a (intranasal drops) / Two Doses
EXPERIMENTALParticipants 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.
Cohort A / Dosage Group 3b (intranasal spray) / Single Dose
EXPERIMENTALParticipants 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.
Cohort B / Dosage Group 4 (intranasal drops) / Single Dose
EXPERIMENTALParticipants 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.
Cohort B / Dosage Group 5 (intranasal drops) / Single Dose
EXPERIMENTALParticipants 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.
Cohort B / Dosage Group 6 (intranasal drops) / Single Dose
EXPERIMENTALParticipants 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.
Interventions
Single intranasal dose on Day 1, by intranasal drops
Single intranasal dose on Day 1, by intranasal drops
Single intranasal dose on Day 1, by intranasal drops
Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day 36 by intranasal drops
Single intranasal dose on Day 1, by intranasal spray
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Wake Research
Raleigh, North Carolina, 27612, United States
Related Publications (2)
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.
PMID: 28000669BACKGROUNDNakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
PMID: 36435633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jay Lieberman, MD
Meissa Vaccines, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 15, 2021
Study Start
April 12, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
August 2, 2022
Record last verified: 2022-08