At a glance
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Phase II Study to Evaluate Immunogenicity and Safety in Subjects With Evidence of Prior Immunity to SARS-CoV-2 of a Single Intramuscular or Intranasal Dose of the Live Recombinant Newcastle Disease Virus Based AVX/COVID-12 Vaccine
In Brief
A Phase 2 clinical trial evaluating Recombinant NDV Vectored Vaccine for SARS-CoV-2 and Placebo for SARS CoV 2 Infection. Completed, enrolled 158 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2
Physiological saline solution of Sodium Chloride at 0.9% After mask opening ChAdOx-1-S\[recombinant\]) Intramuscular