A Booster Dose of Ad5-EBOV in Healthy Adults After Primary Immunization

Ebola Virus Disease Clinical Trial

Official title:

Safety and Immunogenicity of a Booster Dose of the Recombinant Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults After Primary Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533791
• Other study ID #: JSVCT020-2
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2015
• Last updated: October 11, 2015
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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 ß-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

• Current anti-tuberculosis prophylaxis or therapy

• Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Biological:
• 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
one dose, 4×10^10vp/1ml per dose
• 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time
• placebo

Locations

Country	Name	City	State
China	Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention	Taizhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Secondary	Occurrence of adverse events after the vaccination	Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV)	within 28 days after the boosting	Yes
Secondary	Occurrence of serious adverse events after the vaccination	Occurrence of serious adverse events within 28 days after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV)	within 28 days after the boosting	Yes
Secondary	Serum neutralizing antibody against the Ad5-vector	Serum neutralizing antibody against the Ad5-vector 28 days after the boosting	28 days after the boosting	No