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

NCT ID: NCT02533791

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Ebola Virus Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

low dose group

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

one dose, 4×10\^10vp/1ml per dose

high dose group

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

placebo group

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Interventions

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

one dose, 4×10\^10vp/1ml per dose

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 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
• Current anti-tuberculosis prophylaxis or therapy
• Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Institute of Biotechnology

OTHER

Sponsor Role: collaborator

Tianjin Cansino Biotechnology Inc

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng-Cai Zhu

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

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

Taizhou, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28017642 (View on PubMed)

Other Identifiers

JSVCT020-2

Identifier Type: -

Identifier Source: org_study_id