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Ebola Virus DiseasePhase 1NCT02326194

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

A Phase 1 study testing Low dose Ebola Zaire vaccine (Ad5-EBOV) and High dose Ebola Zaire vaccine (Ad5-EBOV) in people with Ebola Virus Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Ebola Virus Disease
What is being tested?
Low dose Ebola Zaire vaccine (Ad5-EBOV) and High dose Ebola Zaire vaccine (Ad5-EBOV)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
Dec 2014to Jul 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Taizhou, Jiangsu

Other trials in China

About this study

Official 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

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.

Being tested
Low dose Ebola Zaire vaccine (Ad5-EBOV), High dose Ebola Zaire vaccine (Ad5-EBOV), placebo (one dose), placebo (two doses)
Keywords
Safety,immunogenicity,Ebola
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02326194
Study groupRoleWhat they receive
Placebo group (one shot)Placebo comparatorone dose
Receives: Biological: placebo (one dose)
Placebo group (two shots)Placebo comparatortwo doses, with one dose to each arm at a same time.
Receives: Biological: placebo (two doses)
Low dose vaccine groupExperimentalone dose, low dose Ebola Zaire vaccine (Ad5-EBOV)
Receives: Biological: Low dose Ebola Zaire vaccine (Ad5-EBOV)
High dose vaccine groupExperimentaltwo doses, high dose, with one dose to each arm at a same time
Receives: Biological: High dose Ebola Zaire vaccine (Ad5-EBOV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of adverse reactions after vaccination.

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

    Measured: within 7 days after the vaccination

  2. 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.

    Measured: 28 days after the vaccination

  3. 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)

    Measured: 28 days after the vaccination

Secondary outcomes (6)

  1. Occurrence of adverse events after the vaccination.

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

    Measured: within 28 days after the vaccination

  2. Changes of the laboratory examinations after vaccination.

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

    Measured: day 0-28 after the vaccination

  3. Occurrence of serious adverse events after the vaccination.

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

    Measured: within 6 months after the vaccination

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

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

    Measured: 168 days after the vaccination

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

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

    Measured: 168 days after the vaccination

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

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

    Measured: 168 days after the vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionFeb 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326194
Sponsor's protocol ID
JSVCT020
Status last verified
Aug 2015
First submitted
22 Dec 2014
Last updated
28 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28017642

  • 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.

    PubMed 25817373

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose Ebola Zaire vaccine (Ad5-EBOV) and High dose Ebola Zaire vaccine (Ad5-EBOV) in people with Ebola Virus Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of adverse reactions after vaccination. (time frame: within 7 days after the vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02326194, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2015.

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