Ebola DiseasePhase 2NCT02575456
A Clinical Trial to Evaluate the Recombinant Human Type5 Adenovirus Vector Based Ebola Virus Disease Vaccine
A Phase 2 study testing Ebola Vaccine in people with Ebola Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in Sierra Leone.
Trial summary
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone. Read more about this study
- Who is it for?
- Ages 8 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Disease
- What is being tested?
- Ebola Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteSierra Leone
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 2
- 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 8 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged between 18 and 50 years
- Able to understand the content of informed consent and signed the informed consent
- Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
- Negative in HIV diagnostic blood test on day of enrollment
- Axillary temperature ≤37.0°C on the day of enrollment
- Non-pregnant females with a negative result in the urine pregnancy test on day of enrollment
- General good health as established by medical history and physical examination.
Who cannot join
- Infected by Ebola virus (inquiry)
- Vaccination with other Ebola vaccine (inquiry)
- HIV infection or other serious immunodeficiency disease (inquiry)
- Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
- Family history of brain or mental disease
- Woman who is pregnant or breast-feeding
Show all 16Show fewer
- Any acute fever disease or infections in last 7 days
- Major congenital defects or not well-controlled chronic illness
- Asplenia or functional asplenia
- Platelet disorder or other bleeding disorder
- 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 other research medicines in last 1 month
- Prior administration of attenuated vaccine(s) in the last one month
- Prior administration of inactivated vaccine(s) in the last 14 days
- Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
- Conditions
- Ebola Disease
- Being tested
- Ebola Vaccine, Placebo
- 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.
Ebola VaccineBiological
PlaceboBiological
control
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | (4×10^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10^10 vp/vial), one shot in each arm, total dose of 1.6×10^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection Receives: Biological: Ebola Vaccine |
| Group B | Experimental | (4×10^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10^10vp/vial), total dose of 8×10^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection Receives: Biological: Ebola Vaccine |
| Group C | Placebo comparator | (0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse reactions after vaccination
Measured: 7 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Measured: 14 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Measured: 28 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Measured: 168 days after vaccination
Secondary outcomes (6)
Occurrence of unsolicited adverse reactions after vaccination
Measured: 28 days after vaccination
Occurrence of serious adverse reaction during the whole follow-up period
Measured: 6 months
Post-vaccination Rate of infected with HIV
Measured: 6 months
Neutralizing antibody titers response to human Ad5
Measured: 14 days after vaccination
Neutralizing antibody titers response to human Ad5
Measured: 28 days after vaccination
Neutralizing antibody titers response to human Ad5
Measured: 168 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc
- Responsible party
- Sponsor
- Investigators
- Alie H Wurie, Principal investigator, Ministry of Health & Sanitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575456
- Sponsor's protocol ID
- JSVCT024
- Status last verified
- Dec 2015
- First submitted
- 11 Oct 2015
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults in Sierra Leone
- ClinicalTrials.gov ID
- NCT02575456
- Acronym / sponsor ID
- JSVCT024
- Conditions
- Ebola Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Beijing Institute of Biotechnology, Tianjin Cansino Biotechnology Inc
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Ebola Vaccine(4×10^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10^10 vp/vial), one shot in each arm, total dose of 1.6×10^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection |
| Group B | Experimental | Biological: Ebola Vaccine(4×10^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10^10vp/vial), total dose of 8×10^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection |
| Group C | Placebo comparator | Biological: Placebo(0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged between 18 and 50 years
- Able to understand the content of informed consent and signed the informed consent
- Able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months).
- Negative in HIV diagnostic blood test on day of enrollment
- Axillary temperature ≤37.0°C on the day of enrollment
Key exclusion criteria (16 listed)
- Infected by Ebola virus (inquiry)
- Vaccination with other Ebola vaccine (inquiry)
- HIV infection or other serious immunodeficiency disease (inquiry)
- Allergic history of any vaccination or drugs, or allergic to any ingredient of the Ad5-EBOV, such as mannitol
- Family history of brain or mental disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ebola Vaccine | Biological | Group A, Group B |
| Placebocontrol | Biological | Group C |
Primary outcome
Occurrence of solicited adverse reactions after vaccination
Time frame: 7 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Time frame: 14 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Time frame: 28 days after vaccination
ELISA antigen-specific assays for antibody to GP responses
Time frame: 168 days after vaccination
6 secondary outcomes
Occurrence of unsolicited adverse reactions after vaccination
Time frame: 28 days after vaccination
Occurrence of serious adverse reaction during the whole follow-up period
Time frame: 6 months
Post-vaccination Rate of infected with HIV
Time frame: 6 months
Neutralizing antibody titers response to human Ad5
Time frame: 14 days after vaccination
Neutralizing antibody titers response to human Ad5
Time frame: 28 days after vaccination
Neutralizing antibody titers response to human Ad5
Time frame: 168 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alie H Wurie principal investigator
Ministry of Health & Sanitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ebola Vaccine in people with Ebola Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in Sierra Leone.
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 7 inclusion and 16 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 1 Sep 2016. 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 Sierra Leone. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 solicited adverse reactions after vaccination (time frame: 7 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2016.