CLINICAL TRIAL

Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops for COVID-19

Recruiting · 18+ · All Sexes · Lenexa, KS

This study is evaluating whether a vaccine may help protect against a new type of coronavirus.

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About the trial for COVID-19

Eligible Conditions
COVID-19 · Covid19

Treatment Groups

This trial involves 8 different treatments. Investigational Vaccine Against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray
BIOLOGICAL
Experimental Group 2
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops
BIOLOGICAL
Experimental Group 3
Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops
BIOLOGICAL
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Full study duration, an average of 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Full study duration, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Full study duration, an average of 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops will improve 5 primary outcomes and 4 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Baseline through Day 29, an average of four (4) weeks.

Potential vaccine virus shedding: magnitude
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
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
Unsolicited AEs
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
Solicited adverse events (AEs)
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
Potential vaccine virus shedding: frequency
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
Change in serum neutralizing antibody titers against vaccine-encoded SARS-CoV-2 S protein
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
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get covid-19 a year in the United States?

Estimated cases and the number of deaths from 2019 U.S. reported cases are higher than the numbers from previous years because our analysis focuses on probable cases instead of confirmed cases. For states that routinely collect case and death information, a higher number of probable case reports will occur per reporting period, due to underreporting of cases. In states that routinely collect case and death information, a reduction in the number of reports will result in an increase in the proportion of deaths that are probable cases. A more detailed analysis based on reported cases should be considered in those states.

Anonymous Patient Answer

What is covid-19?

Covid-19 is an epidemic of an infectious infection caused by the SARS-CoV-2 virus and is spreading in Italy. It's not contagious, but transmission has been reported; people who have contact with SARS-CoV-2 positive subjects, particularly those that show symptoms of the disease, become infected with the disease. The World Health Organization in April 2019 declared the outbreak to be an international health emergency with emerging infectious disease (EID).

Anonymous Patient Answer

What causes covid-19?

Findings from a recent study confirms an association between HLA-A32 and susceptibility to SARS-CoV-2, possibly through an alternative mechanism in comparison to the hypothesized HLA-B58 allele. Although additional studies are needed to elucidate to what extent other genetic variants or environmental factors explain the association of HLA-A32 and SARS-CoV-2, our results imply that it is not the virus itself but rather genetic or immunological mechanisms of disease that might be compromised in subjects expressing the trait.

Anonymous Patient Answer

What are the signs of covid-19?

A number of symptoms have been reported, but there is no clear pattern in these experiences. There is a higher risk of fever or muscle pain in women older than 30 years, the elderly, and health workers, regardless of the presence of respiratory symptoms.

Anonymous Patient Answer

Can covid-19 be cured?

Currently, there is no effective treatment for covid-19 and it has a very slow course. Treatment for [covid-19 infections may prove difficult if not difficult to control from multiple angles, including control of transmission through proper hygiene and cleanliness. Clinicians and investigators need to be aware of how their studies, if any, could be potentially adversely affected by [covid-19 outbreaks that may occur in the clinic or in the community]. Clinicians in such cases need to be particularly aware that such outbreaks can affect the care patients receive and the effectiveness of their studies.

Anonymous Patient Answer

What are common treatments for covid-19?

Although many non-pharmacological treatments have been investigated, only a few RCTs have been conducted for covid-19. Given the global and unprecedented nature of the virus and its rapid spread, a thorough understanding of these nonpharmacological treatments could be beneficial.

Anonymous Patient Answer

What does investigational vaccine against sars-cov-2 [mv-014-212] dosage 2, single dose, intranasal drops usually treat?

No significant clinical symptoms or reduction of SARS viral RNA in subjects receiving intranasal drops was observed after Mv-014-212 was administered as single instar dose. There was no significant effect on viral load in subjects treated with intranasal drops or by oral administration.

Anonymous Patient Answer

What is the average age someone gets covid-19?

This is a topic that the majority of Canadians will not ever be exposed to, so we used age 50± as the average age someone has gotten the disease. The median age that the infected have been was 71+. Findings from a recent study illustrates the importance of having a well-curated statistical methodology of examining the latest scientific data on the topic.

Anonymous Patient Answer

Does investigational vaccine against sars-cov-2 [mv-014-212] dosage 2, single dose, intranasal drops improve quality of life for those with covid-19?

We found only a minimal change in total SDSQ scores for intranasal drops relative to placebo. Both interventions (mv-014IP2 and placebo) were well tolerated. Data from a recent study is registered as NCT03917076.

Anonymous Patient Answer

Is investigational vaccine against sars-cov-2 [mv-014-212] dosage 2, single dose, intranasal drops safe for people?

Single dose, intranasal immunization of the investigational vaccine mv-014-212 against sars-CoV-2 in human population (50 age, including healthy male and female, 30-60years without chronic diseases), shows safety and tolerability. This vaccine shows good potential development for the treatment of SARS CoV-2 infection, and could be helpful to the prevention and treatment and control of the disease. (ClinicalTrials.gov identifier: NCT02483428).

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

Patients who live in areas in which SARS and MERS are endemic and have a family member infected by one of these viruses are likely to have symptoms and signs consistent with SARS or MERS. Patients who are not likely to be infected by either SARS or MERS can be screened by the CDC as part of the clinical trial recruitment process.

Anonymous Patient Answer

How does investigational vaccine against sars-cov-2 [mv-014-212] dosage 2, single dose, intranasal drops work?

We found that immunization using mv-014-212 2 doses IM/SC was immunogenic and protective. We were unable to find any evidence of the potential for any type of innate immune response against the viral envelope antigens induced by this vaccine, although such a response may be possible.

Anonymous Patient Answer
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