Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence (NCT05205746) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of AVX/COVID-12 Vaccine in Subjects With Prior SARS-CoV-2 Immunity Evidence
Mexico158 participantsStarted 2021-11-23
Plain-language summary
This is a Phase II study with single-blinded safety phase followed by double-blinded randomization, placebo-controlled, of administration of a single dose by two different administration routes (intramuscular route or intranasal route), to evaluate immunogenicity and safety of the recombinant SARS-CoV-2 vaccine (AVX/COVID-12 vaccine) based a live Newcastle disease viral vector (rNDV) in 396 healthy subjects with evidence of prior immunity to SARS-CoV-2, followed by a booster response assessment with an intramuscular dose of COVID-19 vaccine (ChAdOx-1 -S\[recombinant\]) in subjects originally randomized to the placebo arm at several research sites in Mexico City.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be ≥ 18 years old.
. Indistinct sex.
. Having given their informed consent.
. No respiratory problems during the last 21 days prior to administration of the single dose.
. No conditions or alterations in the physical examination, laboratory values and cabinet that in the opinion of the investigator may interfere with the participation of the subject in the study or require a more detailed medical study.
. Negative PCR test for SARS-CoV-2 during the screening visit.
. Negative pregnancy test in women with pregnancy potential.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Signature of commitment for the use of highly effective contraceptive methods for at least 30 days after administration of the intramuscular injection or intranasal.
Exclusion criteria
. History of hypersensitivity or allergy to any of the components of the vaccine.
. History of severe anaphylactic reactions from any cause.
. History of seizures.
. Uncontrolled chronic diseases.
. Chronic diseases that require management with immunosuppressive agents or immune response modulators (eg, systemic corticosteroids, cyclosporine, rituximab among others).
. Oncological disease.
. Active participation, or during the last 3 months in any other clinical study or research experimental intervention.
. Use within 30 days prior to screening evaluation of any drug or herbal supplement, or alternative medicine (for example, transfer factor, chlorine dioxide, etc.) aimed at treating or preventing complications or contagion by SARS-CoV-2, or any other condition.