Trials Sponsors Conditions Drugs Pricing

Conditions

Nipah Virus Infection

Keywords

Nipah, Vaccine, Henipah

Outcome Measures

Primary Outcomes (4)

Rate of local and systemic solicited adverse events
e.g., headache, fatigue, fever, etc.that are specifically asked about by the doctor
for 1 week after each innoculation
Incidence of clinically significant abnormalities in clinical safety laboratory test results reported as unsolicited AEs.
e.g. hemoglobin, white blood cell count, neutrophil count, creatinine, etc.
for 1 week after each innoculation
Incidence of unsolicited adverse events
Adverse events that are reported to the doctor beyond what is asked about by the doctor. An adverse event is any undesirable experience associated with the use of a medical product in a patient.
for 1 month after the last vaccination
Incidence of medically attended adverse events and serious adverse events
A reaction to the vaccine that require medical attention. Serious adverse events can include death, hospitalization, disability, and death.
through Day 197

Secondary Outcomes (2)

Determine number of doses and timing of doses required
through day 57
Determine number of doses and timing of doses required
through day 57

Study Arms (9)

Cohort 1, Group 1

EXPERIMENTAL

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.

Biological: HeV-sG-V

Cohort 1, Group 2

PLACEBO COMPARATOR

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.

Biological: Normal Saline Placebo

Cohort 2, Group 3

EXPERIMENTAL

Interventions

HeV-sG-VBiological

A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.

Also known as: Nipah Vaccine, HenipaVaxTM

Cohort 1, Group 1Cohort 2, Group 3Cohort 2, Group 4Cohort 3, Group 6Cohort 3, Group 7Cohort 3, Group 8

Normal Saline Placebo

Eligibility Criteria

Age18 Years - 49 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or non-pregnant female 18 through 49 years of age at the time of consenting and IP administration.
Provides written informed consent prior to performance of any study-specific procedure.

Sponsors & Collaborators

Children's Hospital Medical Center, Cincinnati
Othercollaborator
Auro Vaccines LLC
Industrylead
Coalition for Epidemic Preparedness Innovations

Study Sites (1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

MeSH Terms

Conditions

Henipavirus Infections

Condition Hierarchy (Ancestors)

Paramyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

Robert W. Frenck Jr., MD
Children's Hospital Medical Center, Cincinnati
PRINCIPAL INVESTIGATOR

Enrollment

192 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 13, 2019

Study Start

February 18, 2020

Actual (reported)

You may not qualify if:

Previous immunization with an investigational Nipah or Hendra virus vaccine.
History of disease known to be caused by Nipah or Hendra virus.
Travel to Kerala state, India within the previous three years or planned travel to Kerala sate or Bangladesh during the study period.
Known hypersensitivity to any component of the IPs.
Known hypersensitivity to citrate or ethylene oxide.
History of hypersensitivity to any vaccine.
Administration of any vaccine other than the IP within 28 days prior to IP administration or planned administration through completion of plasmapheresis or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
Administration of any investigational or non-registered drug within 90 days prior to IP administration or planned administration during the study period.
Administration of immunoglobulin or any blood product within 90 days prior to IP administration or planned administration during the study period.
Acute illness or fever (body temperature measured orally ≥ 38°C or 100.4°F) at the time of IP administration (once acute illness/fever is resolved, if appropriate, as per investigator assessment, subject may be screened again).
History of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to immunodeficiency, autoimmunity, bleeding or psychiatric disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease).
Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
History of chronic alcohol consumption or drug abuse that in the opinion of the investigator might compromise adherence to protocol procedures or interfere with planned safety and immunogenicity assessments.
Blood donation or planned blood donation within 28 days prior to IP administration through 28 days after completion of the plasmapheresis session or Visit 5 (Day 57) for subjects not selected for plasmapheresis.
Pregnant.
+5 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (9)

Cohort 1, Group 1

Cohort 1, Group 2

Cohort 2, Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 2, Group 4

Cohort 2, Group 5

Cohort 3, Group 6

Cohort 3, Group 7

Cohort 3, Group 8

Cohort 3, Group 9

You may not qualify if:

Data Sharing

Source record

Locations