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Study of a Live rNDV Based Vaccine Against COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871737
Recruitment Status : Active, not recruiting
First Posted : May 4, 2021
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Agencia Mexicana de Cooperación Internacional para el Desarrollo. AMEXCID
Information provided by (Responsible Party):
Laboratorio Avi-Mex, S.A. de C.V.

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 Disease virus) in 90 healthy volunteers at a single research site in Mexico City.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Patients will be assigned in the order they enter the study into nine treatment groups according to dose and route of administration.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dose-escalation, Open-label, Non-randomized Phase I Study to Evaluate the Safety and Immunogenicity of Three Concentrations of a rNDV Vaccine Against SARS-CoV-2 Administered by the Intranasal and Intramuscular Route to Healthy Volunteers
Actual Study Start Date : May 20, 2021
Actual Primary Completion Date : August 21, 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose, IM-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.
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: Intermediate dose, IM-IM
Group 2. Dose: 10 7.5-7.99 EID 50/dose. Both first and second administration by the intramuscular route, separated by 21 days
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: High dose, IM-IM
Group 3. Dose: 10 8.0-8.49 EID 50/dose. Both first and second administration by the intramuscular route, separated by 21 days.
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: Low dose, IN-IN
Group 4. Dose: 10 7.0-7.49 EID 50/dose. Both first and second administration by the intranasal route, separated by 21 days
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: Intermediate dose, IN-IN
Group 5. Dose: 10 7.5-7.99 EID 50/dose. Both first and second administration by the intranasal route, separated by 21 days
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: High dose, IN-IN
Group 6. Dose: 10 8.0-8.49 EID 50/dose. Both first and second administration by the intranasal route, separated by 21 days
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: Low dose, IN-IM
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
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: Intermediate dose, IN-IM
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
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

Experimental: High dose, IN-IM
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
Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2
Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2




Primary Outcome Measures :
  1. Safety: adverse events [ Time Frame: Day 2 ]
    Incidence of adverse events

  2. Safety: adverse events [ Time Frame: Day 3 ]
    Incidence of adverse events

  3. Safety: adverse events [ Time Frame: Day 4 ]
    Incidence of adverse events

  4. Safety: adverse events [ Time Frame: Day 5 ]
    Incidence of adverse events

  5. Safety: adverse events [ Time Frame: Day 6 ]
    Incidence of adverse events

  6. Safety: adverse events [ Time Frame: Day 7 ]
    Incidence of adverse events

  7. Safety: adverse events [ Time Frame: Day 14 ]
    Incidence of adverse events

  8. Safety: adverse events [ Time Frame: Day 21 ]
    Incidence of adverse events

  9. Safety: adverse events [ Time Frame: Day 28 ]
    Incidence of adverse events

  10. Safety: adverse events [ Time Frame: Day 35 ]
    Incidence of adverse events

  11. Safety: adverse events [ Time Frame: Day 42 ]
    Incidence of adverse events

  12. Safety: adverse events [ Time Frame: Day 90 ]
    Incidence of adverse events

  13. Safety: adverse events [ Time Frame: Day 180 ]
    Incidence of adverse events

  14. Safety: adverse events [ Time Frame: Day 365 ]
    Incidence of adverse events

  15. Safety: Pregnancy test [ Time Frame: Day 1 ]
    Blood hCG (mUI/mL)

  16. Safety: Pregnancy test [ Time Frame: Day 14 ]
    Blood hCG

  17. Safety: Urinalysis [ Time Frame: Day 14 ]
    Qualitative and by sediment examination

  18. Safety: Oxygen saturation [ Time Frame: Day 14 ]
    Pulse oximetry (%)


Secondary Outcome Measures :
  1. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 14 ]
    Serum IgG, IgM

  2. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 21 ]
    Serum IgG, IgM

  3. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 28 ]
    Serum IgG, IgM

  4. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 35 ]
    Serum IgG, IgM

  5. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 42 ]
    Serum IgG, IgM

  6. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 90 ]
    Serum IgG, IgM

  7. Titers of circulating anti-SARS-CoV2 antibodies [ Time Frame: Day 180 ]
    Serum IgG, IgM

  8. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 14 ]
    Serum IgG, IgM

  9. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 21 ]
    Serum IgG, IgM

  10. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 28 ]
    Serum IgG, IgM

  11. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 42 ]
    Serum IgG, IgM

  12. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 90 ]
    Serum IgG, IgM

  13. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 180 ]
    Serum IgG, IgM

  14. Titers of neutralizing anti-SARS-Cov-2 antibodies [ Time Frame: Day 365 ]
    Serum IgG, IgM

  15. Titers of mucosal IgA [ Time Frame: Day 14 ]
    Mucosal IgA

  16. Titers of mucosal IgA [ Time Frame: Day 21 ]
    Mucosal IgA

  17. Titers of mucosal IgA [ Time Frame: Day 28 ]
    Mucosal IgA

  18. Titers of mucosal IgA [ Time Frame: Day 42 ]
    Mucosal IgA

  19. Titers of mucosal IgA [ Time Frame: Day 90 ]
    Mucosal IgA

  20. Titers of mucosal IgA [ Time Frame: Day 180 ]
    Mucosal IgA

  21. Titers of mucosal IgA [ Time Frame: Day 365 ]
    Mucosal IgA

  22. T-cell elicited responses [ Time Frame: Day 14 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein

  23. T-cell elicited responses [ Time Frame: Day 21 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein

  24. T-cell elicited responses [ Time Frame: Day 28 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein

  25. T-cell elicited responses [ Time Frame: Day 42 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein

  26. T-cell elicited responses [ Time Frame: Day 90 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein

  27. T-cell elicited responses [ Time Frame: Day 180 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein

  28. T-cell elicited responses [ Time Frame: Day 365 ]
    Percentage of cells expressing IL2, TNFalpha and IFNgamma by flow cytometry after challenge with spike protein



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871737


Locations
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Mexico
Hospital Medica Sur
Mexico City, Ciudad De Mexico, Mexico
Sponsors and Collaborators
Laboratorio Avi-Mex, S.A. de C.V.
National Council of Science and Technology, Mexico
Agencia Mexicana de Cooperación Internacional para el Desarrollo. AMEXCID
Investigators
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Principal Investigator: Samuel Ponce de Leon, MD Universidad Nacional Autonoma de Mexico
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laboratorio Avi-Mex, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT04871737    
Other Study ID Numbers: AVX-SARS-CoV-2-VAC-001
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorio Avi-Mex, S.A. de C.V.:
Newcastle Disease Virus
rNDV
COVID-19
SARS-Cov-2 Vaccine
COVID-19 Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases