Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    130
  • sponsor
    Meissa Vaccines, Inc.
Updated on 18 July 2021

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.

Details
Condition COVID19
Treatment 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
Clinical Study IdentifierNCT04798001
SponsorMeissa Vaccines, Inc.
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

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
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