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NCT Number: NCT02326194

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

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.

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Key information

Conditions

Ebola Virus Disease Filoviridae Infections Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral Infections Mononegavirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Taizhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Low dose Ebola Zaire vaccine (Ad5-EBOV)

Biological

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

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.

placebo (one dose)

Biological

placebo, one doses

placebo (two doses)

Biological

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

Primary outcomes

  1. Occurrence of adverse reactions after vaccination.

    Time frame: within 7 days after the vaccination

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

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

    Time frame: 28 days after the vaccination

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

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

    Time frame: 28 days after the vaccination

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

Secondary outcomes

  1. Occurrence of adverse events after the vaccination.

    Time frame: within 28 days after the vaccination

    Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).

  2. Changes of the laboratory examinations after vaccination.

    Time frame: day 0-28 after the vaccination

    Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28.

  3. Occurrence of serious adverse events after the vaccination.

    Time frame: within 6 months after the vaccination

    Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV).

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

    Time frame: 168 days after the vaccination

    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA.

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

    Time frame: 168 days after the vaccination

    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS).

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

    Time frame: 168 days after the vaccination

    Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168.

Other outcomes

  1. Changes of the laboratory examinations after vaccination.

    Time frame: day 168 after the vaccination

    Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) at day 168.

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

    Time frame: 3-112 days after the vaccination

    Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112 as measured by ELISA.

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

    Time frame: 3-56 days after the vaccination

    Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 3, 7, 14, 56 and 112.

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

    Time frame: day 7-112 after the vaccination

    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 7, 14, 56 and 112 as measured by intracellular cytokine staining assays (ICS).

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

    Time frame: day 0-168 after the vaccination

    Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 0, 28 and 168 as measured by ELISpot.

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Beijing Institute of Biotechnology
  • Tianjin Cansino Biotechnology Inc

Registry information

Official study title

A Phase 1 Double-blind, Dose-escalation, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults in China

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 25, 2014
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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