Status:
COMPLETED
Study of a Live rNDV Based Vaccine Against COVID-19
Lead Sponsor:
Laboratorio Avi-Mex, S.A. de C.V.
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Agencia Mexicana de Cooperación Internacional para el Desarrollo. AMEXCID
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
The lack of highly effective treatments against COVID-19 and the social and economic impact that the current pandemic has exerted on public health highlights the uncontested importance of developing v...
Eligibility Criteria
Inclusion
- Adult men and women ≥18 year-old and ≤55-year-old.
- Signed informed consent.
- No respiratory disease within last 21 days prior to first dose administration.
- Body Mass Index from 18.0 to 29.0 kg/m2.
- Negative RT-PCR for SARS-Cov-2 infection.
- Negative test for anti-SARS-CoV-2 IgM and IgG antibodies.
- O2 saturation ≥92% by pulse oximetry.
- Normal CT scan of thorax.
- No symptoms from clinical history and normal physical exam at screening visit.
- Lab test values within normal ranges for all the following:
- Urinalysis. Liver enzymes. Renal function tests. Cholesterol and Triglycerides. Fasting glucose. Hematology.
- Negative test for HBsAg, anti-HCV and anti-HIV antibodies. Negative VDRL test.
- Normal electrocardiogram.
- Negative pregnancy test for women with childbearing potential.
- Agreement of all sexually- active volunteers to use highly effective contraceptives over the study period and up to 30 days after the last administration of the experimental vaccine.
- Commitment from all participants to keep social distancing, use of mask and frequent hand washing with soap or antibacterial gel during the study period.
Exclusion
- History of hypersensitivity or allergy to any ingredient of the vaccine.
- History of severe anaphylactic reaction.
- History of seizures.
- History of chronic diseases or cancer.
- Vaccination against SARS-CoV-2 with approved or experimental vaccines.
- Participation in any other study with an experimental intervention within the last 3 months.
- Administration of any other drug or herbal preparation within the last 30 days.
- Any vaccine administered within the last 30 days, including influenza vaccine.
- Fever at the time of entry.
- Blood transfusion or blood components transfusion within the last 4 months.
- Regular activity related to work, social interaction or entertainment that represents an exposure to SARS-Cov-2 higher than that of the general population, as per investigator judgement.
- Drug and alcohol abuse.
- Any medical or not medical condition that could interfere with patient safety, study compliance or data interpretation, as per investigator judgement.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04871737
Start Date
May 20 2021
End Date
September 30 2022
Last Update
July 25 2023
Active Locations (1)
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1
Hospital Medica Sur
Mexico City, Mexico City, Mexico