Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored

Status Suspended

Clinical Trial Summary

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of two doses of the HPIV3/ΔHNF/EbovZ GP vaccine candidate when administered intranasally in healthy adults.

Clinical Trial Description

This study will evaluate the safety, infectivity, and immunogenicity of two doses of the HPIV3/ΔHNF/EbovZ GP vaccine candidate when administered intranasally in healthy adults. Participants will be enrolled sequentially in two cohorts. Participants in Cohort 1 will be randomly assigned to receive two doses of either 10^6.0 PFU/mL of HPIV3/ΔHNF/EbovZ-GP vaccine or placebo. The first dose will be given on Day 0 and the second dose will be given 4-8 weeks later. Participants in Cohort 2 will be randomly assigned to receive two doses of either 10^7.0 PFU/mL of HPIV3/ΔHNF/EbovZ-GP vaccine or placebo on Days 0 and 28. Participants will be admitted to the inpatient unit 2 days prior to receiving their first dose of the vaccine or placebo. While in the inpatient unit, study procedures will include physical examinations, nasal washes, and blood collection. Participants will be discharged from the inpatient unit on Day 8 or thereafter once two consecutive rRT-PCR assay results are below the pre-determined threshold. An additional study visit will occur on Day 14. On Day 26 (+28), participants will be readmitted to the inpatient unit, and will receive their second dose of the vaccine or placebo on Day 28 (+28). Participants will undergo the same study procedures that occurred during the first inpatient stay, and will be discharged 7 days after the second dose, or once the subject is without respiratory symptoms and rRT-PCR assay is below the pre-determined threshold (around Day 35). Additional study visits will occur on Days 42 ± 3, 56 ± 5, 84 ± 5, 112 ± 7, 180 ± 14, 270 ± 14, and 360 ± 30. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03462004
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Suspended
Phase	Phase 1
Start date	March 5, 2018
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00374309` - Experimental Vaccine for Prevention of Ebola Virus Infection	Phase 1
Completed	`NCT03098862` - PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response
Completed	`NCT02509494` - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo	Phase 3
Recruiting	`NCT06093646` - Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda	N/A
Completed	`NCT02495246` - A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV	Phase 1
Completed	`NCT04906629` - INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees	Phase 1
Completed	`NCT05064956` - Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)	Phase 2
Withdrawn	`NCT04268966` - An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola	Phase 2
Completed	`NCT02267109` - Phase 1 Trial of Ebola Vaccine in Mali	Phase 1
Not yet recruiting	`NCT04822376` - Prophylaxis Vaccine Antibodies Ebola	Phase 2
Recruiting	`NCT02333578` - Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment	N/A
Completed	`NCT02662855` - Efficacy of Favipiravir Against Severe Ebola Virus Disease	Phase 2
Active, not recruiting	`NCT04152486` - Effectiveness and Safety of a Heterologous, Two-dose Ebola Vaccine in the DRC	Phase 3
Terminated	`NCT04250168` - Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
Completed	`NCT03161366` - Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine	Phase 3
Completed	`NCT03140774` - Persistence of the Immune Response After Immunisation With Ebola Virus Vaccines
Active, not recruiting	`NCT02876328` - Partnership for Research on Ebola VACcinations	Phase 2
Not yet recruiting	`NCT06126822` - Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination With the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC	Phase 3
Not yet recruiting	`NCT05202288` - Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers	Phase 2
Completed	`NCT02658331` - Evaluation of the FilmArray BioThreat-E Test	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms