Study of a Live rNDV Based Vaccine Against COVID-19
SARS-CoV-2 Infection
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring Newcastle Disease Virus, rNDV, COVID-19, SARS-Cov-2 Vaccine, COVID-19 Vaccine
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Hospital Medica Sur
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Low Dose, IM-IM
Intermediate dose, IM-IM
High dose, IM-IM
Low dose, IN-IN
Intermediate dose, IN-IN
High dose, IN-IN
Low dose, IN-IM
Intermediate dose, IN-IM
High dose, IN-IM
High dose, IM
Group 1. Dose: 10 7.0-7.49 EID 50/dose. Both first and second administration by the intramuscular route, separated by 21 days.
Group 2. Dose: 10 7.5-7.99 EID 50/dose. Both first and second administration by the intramuscular route, separated by 21 days
Group 3. Dose: 10 8.0-8.49 EID 50/dose. Both first and second administration by the intramuscular route, separated by 21 days.
Group 4. Dose: 10 7.0-7.49 EID 50/dose. Both first and second administration by the intranasal route, separated by 21 days
Group 5. Dose: 10 7.5-7.99 EID 50/dose. Both first and second administration by the intranasal route, separated by 21 days
Group 6. Dose: 10 8.0-8.49 EID 50/dose. Both first and second administration by the intranasal route, separated by 21 days
Group 7. Dose: 10 7.0-7.49 EID 50/dose. First administration by the intranasal route and second administration by the intramuscular route, separated by 21 days
Group 8. Dose: 10 7.5-7.99 EID 50/dose. First administration by the intranasal route and second administration by the intramuscular route, separated by 21 days
Group 9. Dose: 10 8.0-8.49 EID 50/dose. First administration by the intranasal route and second administration by the intramuscular route, separated by 21 days
Group 10. Dose: 10 8.0-8.49 EID 50/dose. 3rd administration by the intramuscular route to all the volunteers who agree to participate