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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
Awards & highlights
Study Summary
This trial will test a new Hendra virus vaccine in a small group of healthy adults to see if it is safe and causes 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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
Normal Saline Placebo
2023
Completed Phase 4
~1740
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Auro Vaccines LLCLead Sponsor
4 Previous Clinical Trials
211 Total Patients Enrolled
Coalition for Epidemic Preparedness InnovationsOTHER
35 Previous Clinical Trials
75,156 Total Patients Enrolled
Cincinnati Children's Hospital Medical Center (CCHMC)UNKNOWN
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