A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.

NCT02326194 | Completed Phase 1 DMC

• 1 other identifier: JSVCT020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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℃. This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.

Conditions

Ebola Virus Disease

Keywords

Safety,immunogenicity,Ebola

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 vaccination

• 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 vaccination

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

  Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS)

  28 days after the vaccination

Secondary Outcomes (6)

• Occurrence of adverse events after the vaccination.

  within 28 days after the vaccination

• Changes of the laboratory examinations after vaccination.

  day 0-28 after the vaccination

• Occurrence of serious adverse events after the vaccination.

  within 6 months after the vaccination

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

  168 days after the vaccination

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

  168 days after the vaccination

Other Outcomes (5)

• Changes of the laboratory examinations after vaccination.

  day 168 after the vaccination

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

  3-112 days after the vaccination

• Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).

  3-56 days after the vaccination

Study Arms (4)

Placebo group (one shot)

PLACEBO COMPARATOR

one dose

Biological: placebo (one dose)

Placebo group (two shots)

PLACEBO COMPARATOR

two doses, with one dose to each arm at a same time.

Biological: placebo (two doses)

Low dose vaccine group

EXPERIMENTAL

one dose, low dose Ebola Zaire vaccine (Ad5-EBOV)

Biological: Low dose Ebola Zaire vaccine (Ad5-EBOV)

High dose vaccine group

EXPERIMENTAL

two doses, high dose, with one dose to each arm at a same time

Biological: High dose Ebola Zaire vaccine (Ad5-EBOV)

Interventions

Low dose Ebola Zaire vaccine (Ad5-EBOV) BIOLOGICAL

one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)

Low dose vaccine group

High dose Ebola Zaire vaccine (Ad5-EBOV) BIOLOGICAL

two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.

High dose vaccine group

placebo (one dose) BIOLOGICAL

placebo, one doses

Placebo group (one shot)

placebo (two doses) BIOLOGICAL

placebo, two doses, with one dose to each arm at a same time.

Placebo group (two shots)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60 years.
• 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 6 months).
• A body mass index (BMI) \<35
• Hemoglobin 110-150g/L for female, and 120-160g/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
• Partial thromboplastin time (PTT) 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
• General good health as established by medical history and physical examination.

You may not qualify if:

• Family history of seizure, epilepsy, brain or mental disease
• 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 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Beijing Institute of Biotechnology: collaborator
• Tianjin Cansino Biotechnology Inc: collaborator

Study Sites (1)

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

Taizhou, Jiangsu, China

Location

Related Publications (2)

• 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: 28017642 DERIVED

• Zhu FC, Hou LH, Li JX, Wu SP, Liu P, Zhang GR, Hu YM, Meng FY, Xu JJ, Tang R, Zhang JL, Wang WJ, Duan L, Chu K, Liang Q, Hu JL, Luo L, Zhu T, Wang JZ, Chen W. Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet. 2015 Jun 6;385(9984):2272-9. doi: 10.1016/S0140-6736(15)60553-0. Epub 2015 Mar 25.

  PMID: 25817373 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jiangsu Province Centers for Disease Control and Prevention

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

CN (1)