NDV-HXP-S Vaccine for COVID-19

Recruiting in Palo Alto (17 mi)

Overseen BySean Liu, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sean Liu

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.

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.

I am between 18 and 59 years old and not pregnant.

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

Exclusion Criteria

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

I work in food preparation or childcare with kids under 5.

I have a history of HIV, hepatitis, Guillain-Barré syndrome, or recently received blood products.

I have a history of heart inflammation or abnormal heart tests.

I currently have a fever or signs of an infection.

I have signs or tests suggesting I have COVID-19.

Participant Groups

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.

7Treatment groups

Active Control

Placebo Group

Group I: 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 II: 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 III: 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 IV: 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 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.