Clinical trial NCT04798001: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
Keywords: live attenuated vaccine
safety
immunogenicity
Phase 1 clinical trial
adult
Lead sponsor: Meissa Vaccines, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Solicited adverse events (AEs)
timeFrame: Immediate post-vaccination period
measure: Unsolicited AEs
timeFrame: Immediate post-vaccination period
measure: Serious adverse events (SAEs)
timeFrame: Full study duration, an average of 1 year
measure: Medically attended adverse events (MAEs)
timeFrame: Full study duration, an average of 1 year
measure: Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein
timeFrame: Baseline through Day 29, an average of five (5) weeks
Secondary outcomes:
measure: Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
timeFrame: Baseline through Day 29, an average of five (5) weeks
measure: Potential vaccine virus shedding: frequency
timeFrame: Baseline through Day 29, an average of four (4) weeks
measure: Potential vaccine virus shedding: magnitude
timeFrame: Baseline through Day 29, an average of four (4) weeks
measure: Potential vaccine virus shedding: duration
timeFrame: Baseline through Day 29, an average of four (4) weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Raleigh
country: United States
facility: Wake Research
state: North Carolina
Study officials:
affiliation: Meissa Vaccines, Inc.
name: Jay Lieberman, MD
role: STUDY_DIRECTOR
References:
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.