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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

Must not have

Current or recent use of immunosuppressive medications

Participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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

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I currently have a fever or signs of an infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of local and systemic reactions

Secondary study objectives

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 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.

0 / 9Eligibility criteria met