A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

Status Completed

Clinical Trial Summary

This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.

Clinical Trial Description

This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV.

The whole follow-up period for each participant will be 28 days. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02401373
Study type	Interventional
Source	First Affiliated Hospital of Zhejiang University
Contact
Status	Completed
Phase	Phase 1
Start date	March 2015
Completion date	July 2015

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
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
Completed	`NCT02267109` - Phase 1 Trial of Ebola Vaccine in Mali	Phase 1
Withdrawn	`NCT04268966` - An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola	Phase 2
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
Suspended	`NCT03462004` - Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein	Phase 1
Active, not recruiting	`NCT02876328` - Partnership for Research on Ebola VACcinations	Phase 2
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