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 range18 Years
SexALL
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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.
✓. 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.