AzTrials
AzTrials

Ebola Virus DiseasePhase 1NCT02533791

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

A Phase 1 study testing 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV) and 1.6×10^11vp/2ml 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
Search all trials

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 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Virus Disease
What is being tested?
4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV) and 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteChina
Study dates
Jul 2015to Oct 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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

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

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.

Being tested
4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV), 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV), placebo
Keywords
Safety, immunogenicity, Ebola vaccine, boosting
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.

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

    one dose, 4×10^10vp/1ml per dose

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

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

  • placeboBiological

Study groups in NCT02533791
Study groupRoleWhat they receive
low dose groupExperimental4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
Receives: Biological: 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)
high dose groupExperimental1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
Receives: Biological: 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)
placebo groupPlacebo comparatorplacebo
Receives: Biological: placebo

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 boosting

  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 boosting

  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)

    Measured: 28 days after the boosting

Secondary outcomes (3)

  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 boosting

  2. 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)

    Measured: within 28 days after the boosting

  3. Serum neutralizing antibody against the Ad5-vector

    Serum neutralizing antibody against the Ad5-vector 28 days after the boosting

    Measured: 28 days after the boosting

Timeline

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

  1. First posted27 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2015
  4. Study completionOct 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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02533791
Sponsor's protocol ID
JSVCT020-2
Status last verified
Oct 2015
First submitted
21 Aug 2015
Last updated
14 Oct 2015
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV) and 1.6×10^11vp/2ml 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 6 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 14 Oct 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 boosting). 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 NCT02533791, which also lists 1 linked publication.

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 14 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in