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Safety and Immunogenicity of a Nipah Virus Vaccine

NCT04199169 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2022-11-17

No results posted yet for this study

Summary

A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.

Conditions

  • Nipah Virus Infection

Interventions

BIOLOGICAL

HeV-sG-V

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

BIOLOGICAL

Normal Saline Placebo

0.9% Saline

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Cincinnati Children's Hospital Medical Center (CCHMC)

    collaborator UNKNOWN

  • Auro Vaccines LLC

    lead INDUSTRY

Principal Investigators

  • Robert W. Frenck Jr., MD · Cincinnati Children's Hospital Medical Center (CCHMC)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2022-05-06
Completion
2022-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199169 on ClinicalTrials.gov