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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Meissa Vaccines, Inc.
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Solicited adverse events (AEs)
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
- •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)
Outcomes
Primary Outcomes
Solicited adverse events (AEs)
Time Frame: Immediate post-vaccination period
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration.
Unsolicited AEs
Time Frame: Immediate post-vaccination period
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)
Time Frame: Full study duration, an average of 1 year
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)
Time Frame: Full study duration, an average of 1 year
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
Time Frame: Baseline through Day 29, an average of five (5) weeks
Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Secondary Outcomes
- Potential vaccine virus shedding: magnitude(Baseline through Day 29, an average of four (4) weeks)
- 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: duration(Baseline through Day 29, an average of four (4) weeks)