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
Brief Summary

This study evaluates an investigational vaccine that is designed to protect humansagainst infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. Theinvestigational vaccine, MV-014-212, is a live attenuated vaccine against respiratorysyncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212is administered as drops or a spray in the nose. Specifically, this study analyzes thesafety of, and the immune response to, the vaccine when administered to healthy adultsbetween the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have notreceived a prior vaccine against COVID-19.

Detailed Description

Not Provided

Unknown status
COVID19

Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops

Single intranasal dose on Day 1, by intranasal drops

Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops

Single intranasal dose on Day 1, by intranasal drops

Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops

Single intranasal dose on Day 1, by intranasal drops

Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops

Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day
36 by intranasal drops

Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray

Single intranasal dose on Day 1, by intranasal spray

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 69 Years
Countries
United States
Locations

Johnson County Clin-Trials
Lenexa, Kansas, United States

Wake Research
Raleigh, North Carolina, United States

Contacts

Jay Lieberman, MD
3107538943
jay.lieberman@meissavaccines.com

Jay Lieberman, MD, Study Director
Meissa Vaccines, Inc.

Meissa Vaccines, Inc.
NCT Number
Keywords
live attenuated vaccine
safety
Immunogenicity
Phase 1 clinical trial
Adult
MeSH Terms
COVID-19
Vaccines