NCT04871737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

April 21, 2021

Last Update Submit

July 24, 2023

Conditions

SARS-CoV-2 Infection

Keywords

Newcastle Disease VirusrNDVCOVID-19SARS-Cov-2 VaccineCOVID-19 Vaccine

Outcome Measures

Primary Outcomes (18)

  • Safety: adverse events

    Incidence of adverse events

    Day 2

  • Safety: adverse events

    Incidence of adverse events

    Day 3

  • Safety: adverse events

    Incidence of adverse events

    Day 4

  • Safety: adverse events

    Incidence of adverse events

    Day 5

  • Safety: adverse events

    Incidence of adverse events

    Day 6

  • Safety: adverse events

    Incidence of adverse events

    Day 7

  • Safety: adverse events

    Incidence of adverse events

    Day 14

  • Safety: adverse events

    Incidence of adverse events

    Day 21

  • Safety: adverse events

    Incidence of adverse events

    Day 28

  • Safety: adverse events

    Incidence of adverse events

    Day 35

  • Safety: adverse events

    Incidence of adverse events

    Day 42

  • Safety: adverse events

    Incidence of adverse events

    Day 90

  • Safety: adverse events

    Incidence of adverse events

    Day 180

  • Safety: adverse events

    Incidence of adverse events

    Day 365

  • Safety: Pregnancy test

    Blood hCG (mUI/mL)

    Day 1

  • Safety: Pregnancy test

    Blood hCG

    Day 14

  • Safety: Urinalysis

    Qualitative and by sediment examination

    Day 14

  • Safety: Oxygen saturation

    Pulse oximetry (%)

    Day 14

Secondary Outcomes (36)

  • Titers of circulating anti-SARS-CoV2 antibodies

    Day 14

  • Titers of circulating anti-SARS-CoV2 antibodies

    Day 21

  • Titers of circulating anti-SARS-CoV2 antibodies

    Day 28

  • Titers of circulating anti-SARS-CoV2 antibodies

    Day 35

  • Titers of circulating anti-SARS-CoV2 antibodies

    Day 42

  • +31 more secondary outcomes

Other Outcomes (3)

  • Safety: adverse events [Exploratory Outcomes]

    365 + 14 days after application

  • Safety: adverse events [Exploratory Outcomes]

    365 + 42 days after application

  • Safety: adverse events [Exploratory Outcomes]

    365 + 90 days after application

Study Arms (10)

Low Dose, IM-IM

EXPERIMENTAL

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

Intermediate dose, IM-IM

EXPERIMENTAL

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

High dose, IM-IM

EXPERIMENTAL

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

Low dose, IN-IN

EXPERIMENTAL

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

Intermediate dose, IN-IN

EXPERIMENTAL

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

High dose, IN-IN

EXPERIMENTAL

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

Low dose, IN-IM

EXPERIMENTAL

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

Intermediate dose, IN-IM

EXPERIMENTAL

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

High dose, IN-IM

EXPERIMENTAL

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

High dose, IM

EXPERIMENTAL

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

Biological: Recombinant NDV Vectored Vaccine for SARS-CoV-2

Interventions

Recombinant NDV Vectored Vaccine for SARS-CoV-2BIOLOGICAL

Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2

High dose, IMHigh dose, IM-IMHigh dose, IN-IMHigh dose, IN-INIntermediate dose, IM-IMIntermediate dose, IN-IMIntermediate dose, IN-INLow Dose, IM-IMLow dose, IN-IMLow dose, IN-IN

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Medica Sur

Mexico City, Mexico City, Mexico

Location

Related Publications (8)

  • Honda K, Sakaguchi S, Nakajima C, Watanabe A, Yanai H, Matsumoto M, Ohteki T, Kaisho T, Takaoka A, Akira S, Seya T, Taniguchi T. Selective contribution of IFN-alpha/beta signaling to the maturation of dendritic cells induced by double-stranded RNA or viral infection. Proc Natl Acad Sci U S A. 2003 Sep 16;100(19):10872-7. doi: 10.1073/pnas.1934678100. Epub 2003 Sep 5.

    PMID: 12960379BACKGROUND

  • Czegledi A, Ujvari D, Somogyi E, Wehmann E, Werner O, Lomniczi B. Third genome size category of avian paramyxovirus serotype 1 (Newcastle disease virus) and evolutionary implications. Virus Res. 2006 Sep;120(1-2):36-48. doi: 10.1016/j.virusres.2005.11.009.

    PMID: 16766077BACKGROUND

  • DiNapoli JM, Kotelkin A, Yang L, Elankumaran S, Murphy BR, Samal SK, Collins PL, Bukreyev A. Newcastle disease virus, a host range-restricted virus, as a vaccine vector for intranasal immunization against emerging pathogens. Proc Natl Acad Sci U S A. 2007 Jun 5;104(23):9788-93. doi: 10.1073/pnas.0703584104. Epub 2007 May 29.

    PMID: 17535926BACKGROUND

  • Buijs PR, van Amerongen G, van Nieuwkoop S, Bestebroer TM, van Run PR, Kuiken T, Fouchier RA, van Eijck CH, van den Hoogen BG. Intravenously injected Newcastle disease virus in non-human primates is safe to use for oncolytic virotherapy. Cancer Gene Ther. 2014 Nov;21(11):463-71. doi: 10.1038/cgt.2014.51. Epub 2014 Sep 26.

    PMID: 25257305BACKGROUND

  • Sun W, Leist SR, McCroskery S, Liu Y, Slamanig S, Oliva J, Amanat F, Schafer A, Dinnon KH 3rd, Garcia-Sastre A, Krammer F, Baric RS, Palese P. Newcastle disease virus (NDV) expressing the spike protein of SARS-CoV-2 as a live virus vaccine candidate. EBioMedicine. 2020 Dec;62:103132. doi: 10.1016/j.ebiom.2020.103132. Epub 2020 Nov 21.

    PMID: 33232870BACKGROUND

  • Sun W, McCroskery S, Liu WC, Leist SR, Liu Y, Albrecht RA, Slamanig S, Oliva J, Amanat F, Schafer A, Dinnon KH 3rd, Innis BL, Garcia-Sastre A, Krammer F, Baric RS, Palese P. A Newcastle Disease Virus (NDV) Expressing a Membrane-Anchored Spike as a Cost-Effective Inactivated SARS-CoV-2 Vaccine. Vaccines (Basel). 2020 Dec 17;8(4):771. doi: 10.3390/vaccines8040771.

    PMID: 33348607BACKGROUND

  • Ponce-de-Leon S, Torres M, Soto-Ramirez LE, Calva JJ, Santillan-Doherty P, Carranza-Salazar DE, Carreno JM, Carranza C, Juarez E, Carreto-Binaghi LE, Ramirez-Martinez L, Paz De la Rosa G, Vigueras-Moreno R, Ortiz-Stern A, Lopez-Vidal Y, Macias AE, Torres-Flores J, Rojas-Martinez O, Suarez-Martinez A, Peralta-Sanchez G, Kawabata H, Gonzalez-Dominguez I, Martinez-Guevara JL, Sun W, Sarfati-Mizrahi D, Soto-Priante E, Chagoya-Cortes HE, Lopez-Macias C, Castro-Peralta F, Palese P, Garcia-Sastre A, Krammer F, Lozano-Dubernard B. Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico. NPJ Vaccines. 2023 May 10;8(1):67. doi: 10.1038/s41541-023-00662-6.

    PMID: 37164959DERIVED

  • Ponce-de-Leon S, Torres M, Soto-Ramirez LE, Calva JJ, Santillan-Doherty P, Carranza-Salazar DE, Carreno JM, Carranza C, Juarez E, Carreto-Binaghi LE, Ramirez-Martinez L, Paz-De la Rosa G, Vigueras-Moreno R, Ortiz-Stern A, Lopez-Vidal Y, Macias AE, Torres-Flores J, Rojas-Martinez O, Suarez-Martinez A, Peralta-Sanchez G, Kawabata H, Gonzalez-Dominguez I, Martinez-Guevara JL, Sun W, Sarfati-Mizrahi D, Soto-Priante E, Chagoya-Cortes HE, Lopez-Macias C, Castro-Peralta F, Palese P, Garcia-Sastre A, Krammer F, Lozano-Dubernard B. Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico. medRxiv [Preprint]. 2022 Feb 9:2022.02.08.22270676. doi: 10.1101/2022.02.08.22270676.

    PMID: 35169806DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Samuel Ponce de Leon, MD

    Universidad Nacional Autonoma de Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Patients will be assigned in the order they enter the study into nine treatment groups according to dose and route of administration.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

May 4, 2021

Study Start

May 20, 2021

Primary Completion

August 21, 2022

Study Completion

September 30, 2022

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)