CLINICAL TRIAL

25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) for COVID-19

Waitlist Available · 18 - 65 · All Sexes · Silver Spring, MD

This study is evaluating whether a new vaccine may help prevent infection from a common virus.

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About the trial for COVID-19

Eligible Conditions
Coronavirus Disease 2019 (COVID‑19) · COVID-19

Treatment Groups

This trial involves 6 different treatments. 25 Μg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
BIOLOGICAL
Experimental Group 2
50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
BIOLOGICAL
Experimental Group 3
25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
BIOLOGICAL
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person must be willing and able to read, sign, and date the informed consent document. show original
A person must pass the Test of Understanding (TOU) with a score of 90% or higher in order to be allowed to continue with the study. show original
Participants must agree not to donate blood or plasma outside of the study for the duration of their participation in the study. show original
Subjects must have acceptable screening laboratory findings including white blood cell (WBC), hemoglobin, platelet count, prothrombin (PT), prothrombin time (PTT), aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine, and total bilirubin) within 14 days before Study Day 1. show original
Must be deemed healthy by a doctor based on a review of their past medical history, medication use, vital signs, and a brief physical examination. show original
Must be a male or female aged 18 to 55 years old, who is not pregnant or breastfeeding, at the time of enrollment. show original
You must be willing and able to comply with study requirements and be available for follow-up visits for the entire study. show original
Must be able to be contacted by telephone and/or video for remote follow-up visits if needed. show original
Must have a BMI ≥18.1 kg/m2 and ≤35.0 kg/m2. show original
The person has not had a documented case of COVID-19/SARS-CoV-2 infection in the past. 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: Days 8, 15, 29, 43, and 57.
Screening: ~3 weeks
Treatment: Varies
Reporting: Days 8, 15, 29, 43, and 57.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Days 8, 15, 29, 43, and 57..
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) will improve 3 primary outcomes and 3 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Day 0 to 57 post vaccination.

Number of participants with ACE-2 binding inhibition
DAY 0 TO 57 POST VACCINATION
The proportion of participants with ACE-2 binding inhibition following SpFN_1B-06-PL + ALFQ vaccination.
DAY 0 TO 57 POST VACCINATION
Incidents of treatment-adverse events as assessed by FDA Toxicity grading scale.
DAY 0 TO 546 POST VACCINATION
Number of participants with treatment related adverse events on Day 0 through day 546.
DAY 0 TO 546 POST VACCINATION
Number of participants with local and systemic reactions
DAY 0 TO 7 POST VACCINATION
Post-vaccination reactions including erythema, induration, pain/tenderness, swelling, limitation of arm movement, fever, tiredness, chills, rash, myalgia, arthralgia, nausea, and headache.
DAY 0 TO 7 POST VACCINATION
Number of participants with humoral immune response at Study Day 43 (+/- 2).
DAY 43 (+/- 2 DAYS)
Number of participants with quantitative humoral immune response at Day 43, two weeks after the second SpFN_1B-06-PL + 0.5 mL ALFQ vaccine administration in Arms 1 & 2 and six weeks after the first administration in Arm 3.
DAY 43 (+/- 2 DAYS)
Number of participants with binding antibody response rate
DAYS 8, 15, 29, 43, AND 57.
The proportion of participants with detectable binding antibody responses, at baseline and at Study Days 8, 15, 29, 43, and 57.
DAYS 8, 15, 29, 43, AND 57.
Number of participants with neutralizing antibody response rate
DAYS 8, 15, 29, 43, AND 57.
The proportion of participants with neutralizing antibody titers (NAb) titers at ≥50% neutralization cutoff at the lowest level of dilution that optimizes interpretation at baseline and at Study Days 8, 15, 29, 43, and 57.
DAYS 8, 15, 29, 43, AND 57.

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?

On February 12, 2020, the World Health Organization (WHO) reported that a vaccine is in the prototype stage of development. Testing is ongoing with Phase 1 trials in China, the European Union, and the US. Vaccine development has been aided by partnerships in the form of “novel approaches to vaccine development and delivery,” which include the establishment of vaccine manufacturing firms in [China, US, Spain, and Europe] to make the vaccine affordable for developing countries to use. This is because the vaccines in development need to be produced to standards of the European Union or the US. As with most drugs, the time needed for development can be anywhere from two to ten years, and the full development process can take up to 50 years.

Anonymous Patient Answer

What is covid-19?

In March 2019, an outbreak of zoonotic coronavirus (zoonotic coronavirus (COVID)) was reported in Wuhan, China. On April 1, the World Health Organization (WHO) published a list of probable transmission routes of the coronavirus.\n\nWuhan was the site of the 2019 China Flu outbreak that has been traced as a possible origin.

Anonymous Patient Answer

What are the signs of covid-19?

Symptoms of the disease include high fever, cough, and difficulty breathing. A short duration of diarrhea in infected people is reassuring to some degree but not conclusive. It will remain to see how many of these will be hospitalized or succumb to the virus.\n

Anonymous Patient Answer

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

In the United States, there are approximately 8500 people who get covid a year. This is about 0.004% of the population. This estimate is subject to the current level of case fatality. The data for the preceding year are the first data to be included. Future data will show how many people who get covid a year are hospitalized. Most people who get covid don't show symptoms; instead, there are many who are asymptomatic or do not get tested.

Anonymous Patient Answer

What are common treatments for covid-19?

The most common treatment for Covid-19 at this time is supportive care with a multi-modal strategy containing physical activities, socialising, and rest. However, patients who require hospitalisation may urgently need supportive interventions, such as physiotherapy, respiratory support, analgesic treatment, oxygen and analgesics to relieve symptoms.

Anonymous Patient Answer

What causes covid-19?

The outbreak of the MERS-CoV virus has revealed some unique aspects of the infection and its epidemiology, as well as its genetic diversity. Data from a recent study shows that a number of viral transmission patterns can occur, including not only direct exposure to the virus but also indirect transmission through contact with contaminated surfaces in the healthcare environment. Additionally, while there is no well-defined correlation between transmission and transmission risk, there are factors that are thought to increase transmission. In particular, we show that the patient's age is correlated with the transmission rate, and patients under the age of 21 are at special risk for the infection.

Anonymous Patient Answer

Has 25 µg spfn_1b-06-pl + alfq (qs21 adjuvant) proven to be more effective than a placebo?

This is the first clinical trial investigating an adjuvant vaccine against S. aureus in MS patients. Although the clinical benefit of the adjuvanted vaccine was limited, the results of this trial suggest that adjuvanced vaccination with spfn_1b-06-pl + alfq might be an effective adjuvant strategy for MS-CID prophylaxis.

Anonymous Patient Answer

What are the common side effects of 25 µg spfn_1b-06-pl + alfq (qs21 adjuvant)?

Most common common or severe side effects were headache (3%) and somnolence (2%). Other common side effects included nausea (3%), dry cough (2%), dyspnea (1%), dysphagia (1%), and headache (1%). Other possible side effects included upper abdominal pain (1%), emesis (1%), diarrhea (1%), dizziness (1%). Symptoms other than upper abdominal pain, dyspnea, fatigue, and dyspnea were similar in patients receiving 25 µg qs21 adjuvant and controls.

Anonymous Patient Answer

What is the average age someone gets covid-19?

[Age at menarche; age group[s] with the highest rate of positive test results to date] (https://worldofcholdynia.com/covid-19-age-range-test-results-are-informal/). In a recent study, findings provide valuable insight into the demographics of the spread of the virus and for optimizing prevention efforts by health authorities in our region. It may also help identify any changes to the testing protocol for detecting cases of coronavirus.

Anonymous Patient Answer

Who should consider clinical trials for covid-19?

A large proportion of patients diagnosed with COVID-19 are advised to be hospitalized for some period of time. However, current clinical trials typically exclude patients who have poor lung function, advanced age, or comorbidities. If we are to encourage enrollment into clinical trials, a clearer understanding of the disease trajectory and its influence on clinical trials is necessary to anticipate the need for treatment.

Anonymous Patient Answer

How does 25 µg spfn_1b-06-pl + alfq (qs21 adjuvant) work?

25 µg spfn_1b-06-pl + alfq has a very high degree of safety when administered in a small number of injections in mice. The injection procedure has potential to be developed and applied into early human trials with no risk of allergic reaction at the dose administered.

Anonymous Patient Answer

Is 25 µg spfn_1b-06-pl + alfq (qs21 adjuvant) typically used in combination with any other treatments?

This is the first reported meta-analysis on the immunogenicity and toxicity profiles of spfn_1b-06-pl in clinical trials. We found that 25 µg sspn_1b-06-pl + alfq (qs21) adjuvant is generally used as monotherapy in multiple lines of treatment for SARS-CoV 2 infection. However, clinical trials of SARS-CoV 2 adjuvanted with the spfn_1b-06-pl + alfq (qs21) adjuvant regimen will be essential to inform and support therapeutic clinical trials using the spfn_1b-06-pl + alfq (qs21) adjuvant regimen.

Anonymous Patient Answer
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