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Virus Therapy

NDV-HXP-S Vaccine for COVID-19

Phase 1
Waitlist Available
Led By Sean Liu, MD, PhD
Research Sponsored by Sean Liu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participant is eligible if she is not pregnant or breastfeeding, and meets specific contraceptive requirements
Males and non-pregnant females who are between 18 to 59 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights

Study Summary

This trial will test a new vaccine for COVID-19 that is given either in the nose or in the arm. The vaccine is made from a live virus that has been modified to express the spike protein of SARS-CoV-2. The trial will compare two different doses of the vaccine and will also test a placebo vaccine.

Who is the study for?
Adults aged 18-59 who've completed an FDA-approved COVID-19 vaccine series at least 6 months ago, not pregnant/breastfeeding, agree to contraception and no other clinical trials for a year. Excludes those with certain diseases (HIV, hepatitis), severe vaccine reactions, or immunocompromising conditions.Check my eligibility
What is being tested?
The trial is testing two dosages of NDV-HXP-S, a live recombinant Newcastle disease virus-based COVID-19 vaccine given by intramuscular (IM) injection or nasal spray (IN). Participants will be compared to those receiving saline placebo.See study design
What are the potential side effects?
Potential side effects may include typical vaccination responses such as soreness at the injection site, headache, fever, fatigue. Since it's a live virus vaccine delivered nasally or via injection, there might also be respiratory symptoms like sneezing or coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.
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I am between 18 and 59 years old and not pregnant.
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I have not had COVID-19, tested negative, and have no symptoms.
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I have completed my COVID-19 vaccination over 6 months ago.
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I agree to follow specific rules during and for 90 days after getting the NDV-HXP-S vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of local and systemic reactions
Secondary outcome measures
Number of adverse events (AEs)
Number of medically-attended adverse events (MAAEs)
Number of serious adverse events (SAEs)

Trial Design

7Treatment groups
Active Control
Placebo Group
Group I: Cohort 6: NDV-HXP-S high dose IMActive Control1 Intervention
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.
Group II: Cohort 4: NDV-HXP-S low dose IN+IM in combinationActive Control2 Interventions
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.
Group III: Cohort 7: NDV-HXP-S high dose IN+IM in combinationActive Control2 Interventions
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.
Group IV: Cohort 5: NDV-HXP-S high dose INActive Control1 Intervention
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.
Group V: Cohort 2: NDV-HXP-S low dose INActive Control1 Intervention
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.
Group VI: Cohort 3: NDV-HXP-S low dose IMActive Control1 Intervention
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.
Group VII: Cohort 1: Placebo / Sodium ChloridePlacebo Group1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sean LiuLead Sponsor
Sean Liu, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

NDV-HXP-S (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05181709 — Phase 1
COVID-19 Research Study Groups: Cohort 6: NDV-HXP-S high dose IM, Cohort 4: NDV-HXP-S low dose IN+IM in combination, Cohort 7: NDV-HXP-S high dose IN+IM in combination, Cohort 5: NDV-HXP-S high dose IN, Cohort 1: Placebo / Sodium Chloride, Cohort 2: NDV-HXP-S low dose IN, Cohort 3: NDV-HXP-S low dose IM
COVID-19 Clinical Trial 2023: NDV-HXP-S Highlights & Side Effects. Trial Name: NCT05181709 — Phase 1
NDV-HXP-S (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181709 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are partaking in this clinical trial?

"Confirmed. The information hosted on clinicaltrials.gov reveals that recruitment for this medical trial is still underway, having been initiated February 1st 2022 and most recently updated June 30th 2022. 35 participants are needed at a single site to complete the study."

Answered by AI

Is the research team recruiting patients for participation in this trial?

"According to clinicaltrials.gov, this investigation is still recruiting participants for their trial which was posted on February 1st 2022 and last amended on June 30th of the same year."

Answered by AI

How perilous is the administration of high doses of NDV-HXP-S via intramuscular injection for individuals?

"Power's safety assessment of Cohort 6: NDV-HXP-S high dose IM is a 1, due to limited clinical evidence regarding its efficacy and security."

Answered by AI

Who has the capability to participate in this experiment?

"This experimental trial is searching for 35 individuals diagnosed with Newcastle Disease between the ages of 19 and 59. Before enrolment, applicants must meet a variety of criteria such as providing written consent, being neither pregnant nor trying to conceive, testing negative on an RT-PCR test and SARS-CoV-2 nucleocapsid antibody test at screening, agreeing not to participate in another clinical study related to COVID until day 365 post intervention and granting permission for medical records release. In addition, male participants are asked to use condoms during sexual activity where ejaculate can be passed onto others while WOCBP partners may take advantage of additional highly"

Answered by AI

Are individuals of a younger age bracket eligible to partake in this research?

"The ages of the patients selected for this medical trial must be between 19 and 59 years old."

Answered by AI

What is the traditional function of Cohort 6: NDV-HXP-S high dose IM?

"Cohort 6: NDV-HXP-S high dose IM is a popular remedy for diarrhea, as well as inflammation of the nasal mucosa and corneal edema. It can be used in general surgery applications too."

Answered by AI

Does the research literature contain any other studies related to Cohort 6: NDV-HXP-S high dose IM?

"Currently, there are 100 live experiments researching Cohort 6: NDV-HXP-S high dose IM with 25 trials in the Phase 3 stage. The concentration of these studies is predominantly found in Philadelphia, Pennsylvania; however 385 medical centres across the globe have conducted research on Cohort 6: NDV-HXP-S high dose IM."

Answered by AI
~0 spots leftby Apr 2024