NCT02533791

Brief Summary

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃. In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. The investigators intent to evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study. The investigators expect that the boosting immunization with a same vaccine for primary immunization is possible and could confer a longer-lived protection when needed. The phase I trial has been unblind 28 days after the primary vaccination, but all the subjects are still kept blind as well as the laboratory staffs. Therefore, this booster vaccination trial will be conduct in single blind.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 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

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

August 21, 2015

Last Update Submit

October 11, 2015

Conditions

Ebola Virus Disease

Keywords

SafetyimmunogenicityEbola vaccineboosting

Outcome Measures

Primary Outcomes (3)

  • Occurrence of adverse reactions after vaccination

    Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV)

    within 7 days after the boosting

  • Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV)

    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA

    28 days after the boosting

  • Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV)

    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV)

    28 days after the boosting

Secondary Outcomes (3)

  • Occurrence of adverse events after the vaccination

    within 28 days after the boosting

  • Occurrence of serious adverse events after the vaccination

    within 28 days after the boosting

  • Serum neutralizing antibody against the Ad5-vector

    28 days after the boosting

Study Arms (3)

low dose group

EXPERIMENTAL

4×10\^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)

Biological: 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)

high dose group

EXPERIMENTAL

1.6×10\^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)

Biological: 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)

placebo group

PLACEBO COMPARATOR

placebo

Biological: placebo

Interventions

4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)BIOLOGICAL

one dose, 4×10\^10vp/1ml per dose

low dose group
1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)BIOLOGICAL

two doses, 0.8×10\^11vp/1ml per dose, with one dose to each arm at the same time

high dose group
placeboBIOLOGICAL
placebo group

Eligibility Criteria

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

You may qualify if:

  • Participants who enrolled in the initial study, and completed the primary vaccination.
  • Able to understand the content of the additional informed consent and willing to sign the additional informed consent for the boosting study
  • Able and willing to complete a one-month follow-up.
  • HIV negative
  • Axillary temperature ≤37.0°C on the day of enrollment
  • General good health as established by medical history and physical examination.

You may not qualify if:

  • New occurrence of any of the following situation after the primary vaccination:
  • Subject 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 vaccine, such as mannitol
  • Woman who become pregnant after the primary vaccination or is positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment for the boosting study
  • Any acute fever disease or infections in last 7 days
  • Not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
  • Hereditary angioneurotic edema or acquired angioneurotic edema
  • Urticaria in last 6 months
  • 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)

Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention

Taizhou, Jiangsu, China

Location

Related Publications (1)

  • Li JX, Hou LH, Meng FY, Wu SP, Hu YM, Liang Q, Chu K, Zhang Z, Xu JJ, Tang R, Wang WJ, Liu P, Hu JL, Luo L, Jiang R, Zhu FC, Chen W. Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Glob Health. 2017 Mar;5(3):e324-e334. doi: 10.1016/S2214-109X(16)30367-9. Epub 2016 Dec 23.

    PMID: 28017642DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Feng-Cai Zhu

    Jiangsu Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 27, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

CN(1)