Study of a Live rNDV Based Vaccine Against COVID-19
NCT04871737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2023-07-25
Summary
This is a Phase 1, open-label, non-randomized, dose-escalation study using three doses and two schemes of administration of a recombinant vaccine against SARS-CoV-2 based on a viral vector (Newcastle Disease virus) in 90 healthy volunteers at a single research site in Mexico City.
Conditions
Interventions
- BIOLOGICAL
-
Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2
Sponsors & Collaborators
-
National Council of Science and Technology, Mexico
collaborator OTHER -
Agencia Mexicana de Cooperación Internacional para el Desarrollo. AMEXCID
collaborator UNKNOWN -
Laboratorio Avi-Mex, S.A. de C.V.
lead INDUSTRY
Principal Investigators
-
Samuel Ponce de Leon, MD · Universidad Nacional Autonoma de Mexico
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-05-20
- Primary Completion
- 2022-08-21
- Completion
- 2022-09-30
Countries
- Mexico
Study Locations
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