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Virus Vaccine

Cohort 1, Group 1 for Nipah Virus

Phase 1

Waitlist Available

Led By Robert W. Frenck Jr., MD

Research Sponsored by Auro Vaccines LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 197

Summary

This trial tests a new vaccine for Nipah virus in healthy adults aged 18-49. The vaccine works by introducing a small part of the virus to train the immune system. The study aims to find out if the vaccine is safe and how well it triggers an immune response.

Eligible Conditions

Nipah Virus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 1 month after the last vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 1 month after the last vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 1 month after the last vaccination for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of clinically significant abnormalities in clinical safety laboratory test results reported as unsolicited AEs.

Incidence of medically attended adverse events and serious adverse events

Incidence of unsolicited adverse events

+1 more

Secondary study objectives

Determine number of doses and timing of doses required

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3, Group 8Experimental Treatment2 Interventions

Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) and placebo on Visit 2 (Day 8).

Group II: Cohort 3, Group 7Experimental Treatment2 Interventions

Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) and placebo on Visit 3 (Day 29).

Group III: Cohort 3, Group 6Experimental Treatment2 Interventions

Thirty subjects in the third cohort will receive a 100 mcg dosage of HeV-sG-V on Visit 1 (Day 1) and placebo on Visits 2 and 3 (Days 8 and 29).

Group IV: Cohort 2, Group 4Experimental Treatment2 Interventions

Thirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 3 (Days 1 and 29) with placebo on Visit 2 (Day 8)

Group V: Cohort 2, Group 3Experimental Treatment2 Interventions

Thirty subjects in the second cohort will receive a 30 mcg dosage of HeV-sG-V on Visits 1 and 2 (Days 1 and 8) with placebo on Visit 3 (Day 29).

Group VI: Cohort 1, Group 1Experimental Treatment1 Intervention

Ten subjects in the first cohort will receive a 10 mcg dose of HeV-sG-V on Visits 1 and 6.5 (Days 1 and 169\*). \*Second dose was administered at 6 months due to study pause from local COVID-19 shutdown.

Group VII: Cohort 1, Group 2Placebo Group1 Intervention

Two subjects in the first cohort will receive a dose of the placebo on Visits 1 and 6.5 (Days 1 and 169\*). \*Second dose was administered at 6 months due to study pause from local COVID-19 shutdown.

Group VIII: Cohort 2, Group 5Placebo Group1 Intervention

Twelve subjects in the second cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29).

Group IX: Cohort 3, Group 9Placebo Group1 Intervention

Eighteen subjects in the third cohort will receive a dose of the placebo on Visits 1, 2, and 3 (Days 1, 8 and 29).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HeV-sG-V

2020

Completed Phase 1

~200