CLINICAL TRIAL

SARS-CoV-2 mRNA vaccine formulation 2 for COVID-19

Waitlist Available · 18+ · All Sexes · San Pedro Sula, Honduras

Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older

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About the trial for COVID-19

Treatment Groups

This trial involves 8 different treatments. SARS-CoV-2 MRNA Vaccine Formulation 2 is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
SARS-CoV-2 mRNA vaccine formulation 2
BIOLOGICAL
Experimental Group 2
SARS-CoV-2 mRNA vaccine formulation 1
BIOLOGICAL
Experimental Group 3
SARS-CoV-2 mRNA vaccine formulation 1
BIOLOGICAL
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The participant is not eligible to receive the vaccine because of local guidance, or if they are eligible, they do not intend to receive the authorized/approved vaccine until the key timepoint of Day 43 of follow-up. show original
Subjects who might become pregnant must have a negative pregnancy test within 8 hours of the study intervention. show original
The patient has consented to the surgery. show original
People who are at least 18 years old on the day they are included in a study. show original
A female is considered of non-childbearing potential if she is pre-menarche or post-menopausal for at least 1 year, or surgically sterile. show original
The subject must be of childbearing potential and agree to use an effective contraceptive method or abstain from sexual activity at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.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: From Day 91 to Day 387
Screening: ~3 weeks
Treatment: Varies
Reporting: From Day 91 to Day 387
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From Day 91 to Day 387.
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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 SARS-CoV-2 mRNA vaccine formulation 2 will improve 10 primary outcomes and 10 secondary outcomes in patients with COVID-19. Measurement will happen over the course of From Day 1 up to 8 days post-last injection.

Presence of out-of-range biological test results
FROM DAY 1 UP TO 8 DAYS POST-LAST INJECTION
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test) are considered. The assessment include white blood cell count, hemoglobin, platelet count, clinical chemistry parameters, and coagulation parameters.
FROM DAY 1 UP TO 8 DAYS POST-LAST INJECTION
Presence of unsolicited adverse events
WITHIN 21 DAYS AFTER VACCINATION
Adverse events other than solicited reactions.
WITHIN 21 DAYS AFTER VACCINATION
Presence of solicited injection site reactions and systemic reactions
WITHIN 7 DAYS AFTER VACCINATION
Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills.
WITHIN 7 DAYS AFTER VACCINATION
Presence of immediate adverse events
WITHIN 30 MINUTES AFTER VACCINATION
Immediate adverse events include unsolicited systemic adverse events occurring within 30 minutes after vaccination
WITHIN 30 MINUTES AFTER VACCINATION
2-fold and 4-fold rise in neutralizing antibody titer
FROM DAY 1 TO DAY 36
Fold-rise relative to Day 1.
FROM DAY 1 TO DAY 36
Occurrence of neutralizing antibody seroconversion
FROM DAY 1 TO DAY 36
Seroconversion is defined as baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ post-vaccination
FROM DAY 1 TO DAY 36
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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.

Can covid-19 be cured?

Patients with mild symptoms can self-resolve even if they do not have contact with symptomatic cases, yet some patients may develop more severe symptoms. Patients with severe diseases, including pneumonia, may be at high risk.

Anonymous Patient Answer

What causes covid-19?

We suggest that the cause of SARS and the current outbreak of Covid-19 can be attributed to a combination of infectious agents, environmental triggers, and sociocultural factors. These include the increased rates of co-morbidities, the rapid propagation of the disease, the stigma of the infection of patients, the large number of close contacts and contacts of patients, the rapid change in epidemiological trends, and the lack of effective surveillance and control measures after the initial outbreak. Understanding the causes of these outbreaks will help control and reduce the risk posed by outbreaks in the future.

Anonymous Patient Answer

What are the signs of covid-19?

As with other viral infections, symptoms of coughing and fever are common. More severe symptoms include loss of appetite, fatigue, breathing difficulties, muscle aches, or trouble swallowing especially with lying down. Severe complications with the disease include fever-inducing pneumonias (including acute respiratory distress syndrome), kidney-related problems, and neurological issues (such as headache and neurological problems including confusion, difficulty speaking, seizures, weakness or tremors, and problems with movement).

Anonymous Patient Answer

What is covid-19?

Covid-19 is a novel highly infectious respiratory disease caused by a virus genetically related to SARS. Its spread follows the same predictable pattern as SARS as a novel zoonotic infection, and presents as the same triad comprising fatigue, musculoskeletal abnormalities, and pneumonia. It was first associated with the outbreak in China, and the number of cases has increased dramatically since then. It has been found in other countries, mostly by travellers returning from China, but also in local transmissions, and has now spread worldwide exponentially. Despite a strong link to the epidemic in Hubei province, case numbers are still at the limits of what can be reported openly without causing further transmission.

Anonymous Patient Answer

What are common treatments for covid-19?

There were several common treatments reported to have been used. There is no evidence to support the use of any nonstandard treatments and the evidence suggests that such treatments would be ineffective.\n

Anonymous Patient Answer

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

About 2% of the U.S. population is infected with SARS-CoV-2 and some states are likely to have higher cases as of May. Individuals at high risk include those with medical illnesses, people who frequently travel or are healthcare workers, a history or exposure to a laboratory personnel who has gotten infected and people who live in a community or area where there have been confirmed cases of the disease. The U.S. population is mostly being infected in a cluster. Testing should begin in people who have traveled, have close contacts with an individual who has the disease, or live in areas where there have been confirmed cases.

Anonymous Patient Answer

Have there been any new discoveries for treating covid-19?

There was no strong evidence that any antiviral treatment has shown effectiveness either on the symptomatic or on the death cure of the disease. However, antiviral medications could be helpful in the treatment of mild-to-moderate cases of the disease and as a preventive measure. They have no known side effects and they do not affect the immune system, so they could be very helpful in the treatment of patients with compromised immune systems and they could be used as an alternative or second line option for people who do not respond very well to other preventive measures, such as taking the medication hydroxychloroquine, and a combination of oral antibiotics such as the fluoroquinolone drugs.

Anonymous Patient Answer

What is the latest research for covid-19?

As of April 7, 2020, there are more than 20,000 cases of CODIV-19 in China. Since January 31, the number of CODIV-19 cases increased significantly in Wutong and other cities of Hubei province and Guangdong province of China, and also in Halle, Stadtbusch, and Bickelhöfl. China has reported a total of 2,037 and 4,957 cases of infection, respectively. The two-week average for confirmed cases was 11 in Hubei province and 8 in Guangdong province, with an average of 2.8 confirmed cases per day.

Anonymous Patient Answer

Have there been other clinical trials involving sars-cov-2 mrna vaccine formulation 2?

Findings from a recent study findings revealed that the sars-cov-2 mrna vaccine formulation that we administered, with or without additional protein immunoadjuvants, showed a limited positive immunogenicity and could generate the neutralizing antisera against sars-cov-2 only in one sample from one donor. A large multicenter clinical trial is required to adequately test our vaccine formulation, and further to test the safety and efficacy for the SARS-CoV-2-based vaccine formulation with or without additional protein immunoadjuvants.

Anonymous Patient Answer

What is sars-cov-2 mrna vaccine formulation 2?

(2)A polyprotein mvn (mP2) and the m2(IV) form of the SVCV ORF2(2b) (2b) is suitable as the recombinant vaccine to induce immunologic immunity to SARS-CoV-2. We could also demonstrate a novel and practical approach to develop vaccines for prevention and control against SARS-CoV-2/SARS-CoV-related disease using recombinant nucleocapsid protein as a vaccine adjuvant.

Anonymous Patient Answer

What are the common side effects of sars-cov-2 mrna vaccine formulation 2?

There were no safety concerns identified in this study. Vaccination had acceptable safety profile in the study area of Saudi Arabia. [https://www.dengue.gov.sa/dengue-surveillance.aspx\n\n- SARS-Cov-2\n- Pandemic (disambiguation)"

"Eosia\n\nEosia is a genus of moths of the family Noctuidae described by Pierre André Latreille in 1809.

Anonymous Patient Answer

Does sars-cov-2 mrna vaccine formulation 2 improve quality of life for those with covid-19?

Vaccination with sars-cov-2 M2e antigen did not improve HRQOI on the whole. However, patients who received vaccine had a better overall recovery time than those who did not receive vaccine. In patients with comorbidities, those who received vaccine had a shorter recovery time than those who did not receive vaccine. The longer the recovery time in patients who received vaccine, the greater the improvement in overall recovery time and HRQoL.

Anonymous Patient Answer
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