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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02564575
Other study ID # CIR 305
Secondary ID
Status Completed
Phase Phase 1
First received September 29, 2015
Last updated January 31, 2017
Start date August 2015
Est. completion date November 2016

Study information

Verified date January 2017
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
HPIV3-EbovZ GP Vaccine
Administered intranasally by a VaxINator device

Locations

Country Name City State
United States Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHBSPH) Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of vaccine-related reactogenicity events Measured through Day 56
Primary Number of vaccinees infected with HPIV3-EbovZ GP vaccine virus when given at 10^6.0 or 10^7.0 PFU Infection is defined as the recovery of vaccine virus from nasal wash, and/or the detection of virus in nasal wash by rRT-PCR, and/or a =4-fold rise in serum antibody titer to ebolavirus GP or HPIV3. Measured through Day 360
Primary The titer of vaccine virus recovered from nasal wash specimens obtained from each recipient Measured through Day 360
Primary Number of days vaccine virus was shed, measured by plaque titration and rRT-PCR Measured through Day 360
Secondary Development of serum antibody to the EbovZ-GP Measured through Day 360
See also
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Completed NCT02283099 - Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP) Phase 1
Terminated NCT02661464 - Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo Phase 3
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Available NCT05067166 - Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP