Recruiting
Phase 1

RSV Vaccine

Sponsor:

Meissa Vaccines, Inc.

Code:

NCT04798001

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Accepted

Interventions

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

Study Details

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.

Conditions

Covid19

Study ID

NCT04798001

Start date

Apr 12, 2021

Status verified date

Aug, 2022

Completion date

Oct 31, 2022

Anticipated

Primary completion date

Oct 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cohort A / Dosage Group 1 (intranasal drops) / Single Dose

Participants 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.

experimental: Cohort A / Dosage Group 2 (intranasal drops) / Single Dose

Participants 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.

experimental: Cohort A / Dosage Group 3a (intranasal drops) / Single Dose

Participants 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.

experimental: Cohort A / Dosage Group 3a (intranasal drops) / Two Doses

Participants 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.

experimental: Cohort A / Dosage Group 3b (intranasal spray) / Single Dose

Participants 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.

experimental: Cohort B / Dosage Group 4 (intranasal drops) / Single Dose

Participants 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.

experimental: Cohort B / Dosage Group 5 (intranasal drops) / Single Dose

Participants 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.

experimental: Cohort B / Dosage Group 6 (intranasal drops) / Single Dose

Participants 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

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

Single intranasal dose on Day 1, by intranasal drops

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

Single intranasal dose on Day 1, by intranasal drops

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

Single intranasal dose on Day 1, by intranasal drops

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

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

Single intranasal dose on Day 1, by intranasal spray

Primary outcome measure

  • Solicited adverse events (AEs) [ Time Frame: Immediate post-vaccination period ]
  • Unsolicited AEs [ Time Frame: Immediate post-vaccination period ]
  • Serious adverse events (SAEs) [ Time Frame: Full study duration, an average of 1 year ]
  • Medically attended adverse events (MAEs) [ Time Frame: Full study duration, an average of 1 year ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jay Lieberman, MD

3107538943jay.lieberman@meissavaccines.com

Locations

Johnson County Clin-Trials

Recruiting

Lenexa, Kansas, United States, 66219

Contacts

Mazen Zari, MS.cs, RRT

913-825-4400mzari@jcct.com

Principal Investigator:

Carlos Fierro, MD

Wake Research

Recruiting

Raleigh, North Carolina, United States, 27612

Contacts

Makayla Dutton

mdutton@wakeresearch.com

Principal Investigator:

Lisa M Cohen, DO

More Information

Sponsor

Meissa Vaccines, Inc.

Last update posted

Aug 2, 2022

Last verified

Aug, 2022

Keywords

  • live attenuated vaccine
  • safety
  • immunogenicity
  • Phase 1 clinical trial
  • adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Meissa Vaccines, Inc. on 2022-08-02.