NDV-HXP-S Vaccine for COVID-19

Overseen By Geneva Ortiz

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sean Liu

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: COVID-19, Immunocompromised, Pregnancy, others

Compensation: Varies

Number of Visits: 1

Duration: 14 days

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sean Liu, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

I am not pregnant or breastfeeding and follow the required contraceptive guidelines.

Willing and able to provide written informed consent prior to performing study procedures

I have not had COVID-19, tested negative, and have no symptoms.

Exclusion Criteria

You have a high level of COVID-19 antibodies or tested negative for COVID-19 antibodies.

I am currently taking or have recently taken drugs that weaken my immune system.

You have been exposed to Newcastle Disease Virus (NDV) through handling birds, working on a poultry farm, or doing research with the virus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NDV-HXP-S vaccine or placebo in an ambulatory setting, followed by home isolation with daily at-home sample collection and online symptom reporting

14 days

1 visit (in-person), daily monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of adverse events

365 days

Treatment Details

Interventions

• NDV-HXP-S

Trial Overview 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.

Participant Groups

Group I: Cohort 7: NDV-HXP-S high dose IN+IM in combination Active Control 2 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 II: Cohort 5: NDV-HXP-S high dose IN Active Control 1 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 III: Cohort 6: NDV-HXP-S high dose IM Active Control 1 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 IV: Cohort 4: NDV-HXP-S low dose IN+IM in combination Active Control 2 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 V: Cohort 2: NDV-HXP-S low dose IN Active Control 1 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 IM Active Control 1 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 Chloride Placebo Group 1 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.

Who Is Running the Clinical Trial?

Sean Liu

Lead Sponsor

Trials

1

Recruited

40+