AzTrials
AzTrials

Covid19Phase 1NCT04798001

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

A Phase 1 study testing 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 and Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops in people with Covid19, run by Meissa Vaccines, Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
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 and Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesUnited States
Study dates
12 Apr 2021to 31 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Jay Lieberman, MD contact

3107538943

jay.lieberman@meissavaccines.com

United States2 sites, 2 recruiting

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

    Mazen Zari, MS.cs, RRT, 913-825-4400, mzari@jcct.com

    Carlos Fierro, MD

    Recruiting

  • Wake Research

    Raleigh, North Carolina, 27612

    Makayla Dutton, mdutton@wakeresearch.com

    Lisa M Cohen, DO

    Recruiting

Other trials in United States

About this study

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

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
Being tested
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
Keywords
live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, adult
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Single intranasal dose on Day 1, by intranasal drops

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

    Single intranasal dose on Day 1, by intranasal drops

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

    Single intranasal dose on Day 1, by intranasal drops

  • Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal DropsBiological

    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 SprayBiological

    Single intranasal dose on Day 1, by intranasal spray

Study groups in NCT04798001
Study groupRoleWhat they receive
Cohort A / Dosage Group 1 (intranasal drops) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops
Cohort A / Dosage Group 2 (intranasal drops) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops
Cohort A / Dosage Group 3a (intranasal drops) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops
Cohort A / Dosage Group 3a (intranasal drops) / Two DosesExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops
Cohort A / Dosage Group 3b (intranasal spray) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray
Cohort B / Dosage Group 4 (intranasal drops) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops
Cohort B / Dosage Group 5 (intranasal drops) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops
Cohort B / Dosage Group 6 (intranasal drops) / Single DoseExperimentalParticipants 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.
Receives: Biological: Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Solicited adverse events (AEs)

    Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration.

    Measured: Immediate post-vaccination period

  2. Unsolicited AEs

    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.

    Measured: Immediate post-vaccination period

  3. Serious adverse events (SAEs)

    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.

    Measured: Full study duration, an average of 1 year

  4. Medically attended adverse events (MAEs)

    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.

    Measured: Full study duration, an average of 1 year

  5. Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein

    Change in serum neutralizing antibody (nAb) titers against vaccine-encoded SARS-CoV-2 S protein will be measured per participant

    Measured: Baseline through Day 29, an average of five (5) weeks

Secondary outcomes (4)

  1. Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein

    Change in serum binding antibody concentrations against vaccine-encoded SARS-CoV-2 S protein will be measured per participant

    Measured: Baseline through Day 29, an average of five (5) weeks

  2. Potential vaccine virus shedding: frequency

    Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall

    Measured: Baseline through Day 29, an average of four (4) weeks

  3. Potential vaccine virus shedding: magnitude

    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

    Measured: Baseline through Day 29, an average of four (4) weeks

  4. Potential vaccine virus shedding: duration

    If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall

    Measured: Baseline through Day 29, an average of four (4) weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start12 Apr 2021
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04798001
Sponsor's protocol ID
MV-101
Status last verified
Aug 2022
First submitted
9 Mar 2021
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 28000669

  • Nakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.

    PubMed 36435633

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 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 and Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops in people with Covid19, run by Meissa Vaccines, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jay Lieberman, MD (3107538943, jay.lieberman@meissavaccines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited adverse events (AEs) (time frame: Immediate post-vaccination period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04798001, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in