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

August 1, 2022 updated by: Meissa Vaccines, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Recruiting
        • Johnson County Clin-Trials
        • Contact:
          • Mazen Zari, MS.cs, RRT
          • Phone Number: 913-825-4400
          • Email: mzari@jcct.com
        • Principal Investigator:
          • Carlos Fierro, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Wake Research
        • Contact:
        • Principal Investigator:
          • Lisa M Cohen, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediate post-vaccination period
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.
Full study duration, an average of 1 year
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.
Immediate post-vaccination period
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.
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
Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Baseline through Day 29, an average of five (5) weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein
Time Frame: Baseline through Day 29, an average of five (5) weeks
Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein will be measured per participant
Baseline through Day 29, an average of five (5) weeks
Potential vaccine virus shedding: frequency
Time Frame: Baseline through Day 29, an average of four (4) weeks
Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall
Baseline through Day 29, an average of four (4) weeks
Potential vaccine virus shedding: magnitude
Time Frame: Baseline through Day 29, an average of four (4) weeks
If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall
Baseline through Day 29, an average of four (4) weeks
Potential vaccine virus shedding: duration
Time Frame: Baseline through Day 29, an average of four (4) weeks
If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall
Baseline through Day 29, an average of four (4) weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meissa Vaccines, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2021

Primary Completion (ANTICIPATED)

October 31, 2022

Study Completion (ANTICIPATED)

October 31, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (ACTUAL)

March 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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