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Trivalent Coronavirus Vaccine VBI-2901a for COVID-19
Study Summary
This trial is testing a vaccine candidate that uses particles to express the spike proteins of three coronaviruses: SARS-CoV-2, SARS-CoV-1, and MERS-CoV. The Phase 1 study will compare the safety of two doses of the vaccine candidate in adults 18-64 years old who have previously received two or more vaccinations for COVID-19. The purpose of the study is to test the safety of the vaccine candidate and to learn more about its ability to boost immunity against SARS-CoV-2 and the other two coronaviruses.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- Women participants.You had a flu shot or other similar vaccines within 2 weeks before joining the study.You have HIV, hepatitis C, or hepatitis B.You had a serious case of COVID-19 in the past.You have had a previous infection with SARS-CoV-1 or MERS.You have abnormal results from a physical exam or blood/urine tests that could impact your health.You have tested positive for COVID-19.You are between 18 and 64 years old.You have taken immune-suppressing drugs for more than 14 days in the last 6 months, except for inhaled or topical steroids.You have a condition that affects your immune system, like an autoimmune disease.You had a live vaccine (like the shingles vaccine) within the past 4 weeks.You have a medical or mental health condition, including recent suicidal thoughts or behavior, that could make it risky for you to take part in the study.You have any abnormal laboratory test results that are considered moderate or severe and are important to the study doctor.You have had chemotherapy or radiation for cancer within the last 5 years.
- Group 1: Group G2
- Group 2: Group G3
- Group 3: Group G1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants have enrolled in this research project?
"Affirmative. Clinicaltrials.gov boasts that this medical trial, first posted on October 5th 2022, is seeking participants. The study requires 99 volunteers to be recruited from 7 sites in total."
Are there any North American locations where this investigation is being conducted?
"Seven medical institutions around Canada are currently accepting patients for this trial. These include Manna Research Inc in Pointe-Claire, Ottawa Hospital in Toronto and LMC Manna Toronto located in Halifax, among several others."
Are there still available slots for enrollees in this clinical trial?
"According to data hosted on clinicaltrials.gov, this medical experiment is still open for patient recruitment. It was first announced on October 5th 2022 and the most recent edits were made November 16th of that same year."
Could you elucidate the dangers of VBI-2901a to human health?
"Taking into account the fact this is a Phase 1 trial, with limited evidence for both safety and efficacy, VBI-2901a was given an estimated rating of 1."
Are geriatric patients eligible for enrollment in this experiment?
"To participate in this trial, patients must fall between the ages of 18-64. There are also 141 clinical trials specifically catering to minors and 915 studies dedicated to elderly individuals."
To whom is enrollment available for this investigation?
"This research programme is taking in 99 individuals aged 18 to 64 that have been identified as having COVID-19. Aside from meeting this age and diagnosis criteria, prospective participants must also fulfill the following conditions: Male or female subject between 18 and 64 years of age, lacking any medical issues that require treatment or a change of medication within 6 months before enrollment; those with prior evidence of mild coronavirus symptoms who fully recovered at least 6 months ago are eligible too; Female candidates need to be postmenopausal (at least 12 consecutive months without menstruation) or surgically sterile (with hysterectomy, oophorectomy"
What is the fundamental purpose of this clinical inquiry?
"According to the clinical trial sponsor, VBI Vaccines Inc., primary outcomes that will be observed over a 7 day period after each vaccination include medically-attended adverse events within 28 days of study initiation and conclusion. In addition, secondary objectives such as interferon-gamma positive cells against spike protein from SARS-CoV-2 ancestral (Wuhan) strain, selected variants (Beta, Delta and Omicron), SARS-CoV 1 & MERS CoV at Days 1, 7, 28 56 63 & 84; serum binding IgG subclasses for Th1(IgG1&Ig"
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
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