NCT02401373

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

March 24, 2015

Last Update Submit

July 15, 2015

Conditions

Ebola Virus Disease

Keywords

VaccinesEbola Virus Disease

Outcome Measures

Primary Outcomes (1)

  • A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.

    From March to July, 2015

Study Arms (2)

low dose

EXPERIMENTAL

30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

Biological: Ad5-EBOV

High dose

EXPERIMENTAL

After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV).

Biological: Ad5-EBOV

Interventions

Ad5-EBOVBIOLOGICAL

intramuscular injection

High doselow dose

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 60 years.
  • African in China.
  • Able to understand the content of informed consent and willing to sign the informed consent
  • Able and willing to complete all the secluded study process during the whole study follow-up period (about 1 month).
  • A body mass index (BMI) 18.5-35.0 kg/m2
  • Hemoglobin ≥110g/L for female, and ≥120g/L for male.
  • White blood cells (WBC) 4.0-10.0×109 cells/L
  • Total lymphocyte Count 0.8-4.5×109 cells/L
  • Platelets 100-300×109 cells/L
  • Alanine aminotransferase (ALT) 0-40U/L
  • Serum creatinine 44-106μmol/L
  • Active partial thromboplastin time (APTT) 20-40 seconds
  • Prothrombin time (PT) 10-14 seconds
  • Negative in HIV diagnostic blood test
  • Axillary temperature ≤37.0°C on the day of enrollment
  • +1 more criteria

You may not qualify if:

  • Family history of seizure, epilepsy, brain or mental disease
  • Participant that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol.
  • Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
  • Any acute fever disease or infections in last 7 days
  • Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
  • Hereditary angioneurotic edema or acquired angioneurotic edema
  • Urticaria in last one year
  • Asplenia or functional asplenia
  • Platelet disorder or other bleeding disorder may cause injection contraindication
  • Faint at the sight of blood or needles.
  • Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months
  • Prior administration of blood products in last 4 months
  • Prior administration of other research medicines in last 1 month
  • Prior administration of attenuated vaccine in last 1 month
  • Prior administration of inactivated vaccine in last 14 days
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

  • Wu L, Zhang Z, Gao H, Li Y, Hou L, Yao H, Wu S, Liu J, Wang L, Zhai Y, Ou H, Lin M, Wu X, Liu J, Lang G, Xin Q, Wu G, Luo L, Liu P, Shentu J, Wu N, Sheng J, Qiu Y, Chen W, Li L. Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Hum Vaccin Immunother. 2017 Sep 2;13(9):2078-2085. doi: 10.1080/21645515.2017.1342021. Epub 2017 Jul 14.

    PMID: 28708962DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Lanjuan Li

    First Affiliated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academy of Engineering

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

CN(1)