We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05181709
Recruitment Status : Recruiting
First Posted : January 6, 2022
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Sean Liu, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 4, 2022
First Posted Date  ICMJE January 6, 2022
Last Update Posted Date July 5, 2022
Actual Study Start Date  ICMJE February 1, 2022
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2022)
Number of local and systemic reactions [ Time Frame: 14 days ]
The safety and tolerability profile assessed by the number of local and systemic reactions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2022)
  • Number of adverse events (AEs) [ Time Frame: 365 days ]
    The safety and tolerability profile assessed by the number of serious adverse events.
  • Number of serious adverse events (SAEs) [ Time Frame: 365 days ]
    The safety and tolerability profile assessed by the number of serious adverse events.
  • Number of medically-attended adverse events (MAAEs) [ Time Frame: 365 days ]
    The safety and tolerability profile assessed by the number of medically-attended adverse events (MAAEs).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.
Official Title  ICMJE A Phase-1, Open-Label, Placebo-Controlled Evaluation of a Live, Recombinant Newcastle Disease Virus Expressing the Spike Protein of SARS-CoV-2 (NDV-HXP-S), an Investigational Product for Intranasal (IN) and/or Intramuscular (IM) Vaccination in Healthy Adults Previously Immunized Against COVID-19.
Brief Summary This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in healthy adults previously immunized against COVID-19. The IN and IM live virus vaccinations will be identical in composition and only differ in route of administration.
Detailed Description

Primary Study Objective: To evaluate the safety and tolerability profile of two dose levels of the NDV-HXP-S vaccine as an IN, IM, or a combined administration IN+IM to healthy, previously immunized adults up to 14 days after administration.

Secondary Study Objective: To evaluate the safety and tolerability profile of two dose levels of the NDV-HXP-S vaccine as an IN, IM, or a combined administration IN+IM to healthy, previously immunized adults up to 365 days after administration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Random and Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Drug: Sodium Chloride
    Administered intranasal (IN) and intramuscular (IM) in combination
    Other Name: Placebo
  • Biological: NDV-HXP-S IN low dose

    Allantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride.

    Strength: 3.3x108^8 EID50.

  • Biological: NDV-HXP-S IM low dose

    Allantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride.

    Strength: 3.3x10^8 EID50.

  • Biological: NDV-HXP-S IN high dose
    Allantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10^9 EID50.
  • Biological: NDV-HXP-S IM high dose
    Allantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10^9 EID50.
Study Arms  ICMJE
  • Placebo Comparator: Cohort 1: Placebo / Sodium Chloride
    Participants in Cohort 1 will receive placebo given IN+IM in combination. Placebo administration will be given in an ambulatory setting. IN administration will be immediately followed by IM administration. Participants will be monitored by the research staff for 1-hour after administration. Participants will be permitted to receive any additional federally authorized or approved vaccines 56 days after receiving placebo.
    Intervention: Drug: Sodium Chloride
  • Active Comparator: Cohort 2: NDV-HXP-S low dose IN
    Participants in Cohort 2 (low, IN) will receive a single administration of a low dose of NDV-HXP-S at 3.3x108 Egg-Infectious Dose50 (EID50). Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
    Intervention: Biological: NDV-HXP-S IN low dose
  • Active Comparator: Cohort 3: NDV-HXP-S low dose IM
    Participants in Cohort 3 (low, IM) will receive a single administration of a low dose of NDV-HXP-S at 3.3x108 Egg-Infectious Dose50 (EID50). Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
    Intervention: Biological: NDV-HXP-S IM low dose
  • Active Comparator: Cohort 4: NDV-HXP-S low dose IN+IM in combination
    Participants in Cohort 4 (low, IN+IM) will receive low doses of NDV-HXP-S at 3.3x108 EID50. Participants will be given NDV-HXP-S in an ambulatory setting where IN and IM doses will be given in succession. Participants will be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
    Interventions:
    • Biological: NDV-HXP-S IN low dose
    • Biological: NDV-HXP-S IM low dose
  • Active Comparator: Cohort 5: NDV-HXP-S high dose IN
    Participants in Cohort 5 (high, IN) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will ONLY enroll into Cohort 5 if Cohort 2 (low dose IN) did not have any SAEs that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
    Intervention: Biological: NDV-HXP-S IN high dose
  • Active Comparator: Cohort 6: NDV-HXP-S high dose IM
    Participants in Cohort 6 (high, IM) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will ONLY enroll into Cohort 6 if Cohort 3 (low dose IM) did not have any SAEs that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
    Intervention: Biological: NDV-HXP-S IM high dose
  • Active Comparator: Cohort 7: NDV-HXP-S high dose IN+IM in combination
    Participants in Cohort 7 (high, IN+IM) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will only enroll into Cohort 7 if Cohort 4 did not have an SAE that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collection and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
    Interventions:
    • Biological: NDV-HXP-S IN high dose
    • Biological: NDV-HXP-S IM high dose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2022)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing and able to provide written informed consent prior to performing study procedures.
  • Males and non-pregnant females who are between 18 to 59 years of age.
  • Asymptomatic, RT-PCR negative (at screening) AND without a known prior history of COVID-19 infection (requiring a negative SARS-CoV-2 nucleocapsid antibody test result at screening).
  • Provides documentation showing completion of a FDA authorized or approved COVID-19 vaccination regimen, where the last administration was ≥ 6 months (180 days) from the study enrollment date.
  • IF FEMALE PARTICIPANT: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:

    • Is not a woman of child-bearing potential (WOCBP); OR
    • Is a WOCBP and using an acceptable contraceptive method during the intervention period (for a minimum of 90 days after NDV-HXP-S vaccination). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Only highly effective methods of contraception that have a low user dependency or a combination of highly effective methods that are user dependent may be used.
  • IF MALE PARTICIPANT: Agrees to the following requirements during the intervention period and for at least 90 days after NDV-HXP-S vaccination, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s):

    • Refrain from donating sperm AND be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR
    • Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. In addition to male condom use, a highly effective method of contraception may be considered in WOCBP partners of male participants.
  • Participant understands and agrees to comply with planned study procedures.
  • Participant agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 through Day 365.
  • Participant agrees to not receive any other vaccination (including COVID-19 vaccine) through Day 56.

    • Provides consent for release of information for hospitalization records and other medically attended visits during the study.

Exclusion Criteria:

  • Clinical and/or laboratory evidence indicative of COVID-19 infection.
  • Demonstrates a STRONG COVID-19 positive antibody serology (>12500 AU/ml per chemiluminescent microparticle immunoassay (including AdviseDx SARS-CoV-2 IgG II)) or a NEGATIVE COVID-19 serology on screening against SARS-CoV-2 spike protein.
  • History of hypersensitivity to egg products.
  • History of severe reactions to vaccinations.
  • Potential for prior NDV exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with NDV).
  • History of an immunocompromising medical condition (such as primary immunodeficiencies, AIDS, or neutropenia).
  • Current or recent use of immunosuppressive medications (i.e. any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator.
  • Any history of HIV, hepatitis C, hepatitis B (by laboratory testing and/or history), Guillain-Barré syndrome, and/or recent receipt of immunoglobulins and/or blood products.
  • Pregnancy or actively breastfeeding.
  • Other medical condition which may place subject at increased risk for harm due to participation in the study as determined by the investigator.
  • In the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of SARS-CoV-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle SARS-CoV-2.
  • Participants at higher risk of severe COVID-19, as defined by CDC guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. This guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people.
  • Participants with fever or signs of acute infection, including symptoms that could indicate SARS-CoV-2 infection.
  • Participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration.
  • Participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger.
  • Participants who have close or household high-risk contacts including but not limited to:

    • Persons more than or equal to 65 years of age
    • Children less than or equal to 5 years of age.
    • Residents of nursing homes.
    • Persons of any age with significant chronic medical conditions as well as immunosuppression or cancer.
    • Women who are pregnant, trying to become pregnant, or breastfeeding.
  • Participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Geneva Ortiz (212) 824-7714 CovidTrialsInfo@mountsinai.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05181709
Other Study ID Numbers  ICMJE STUDY-21-01589
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after de-identification.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Immediately following publication. No end date.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. To achieve aims in the approved proposal.
Current Responsible Party Sean Liu, Icahn School of Medicine at Mount Sinai
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sean Liu
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean Liu, MD, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP