Ebola Virus DiseasePhase 1NCT02401373
A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.
A Phase 1 study testing Ad5-EBOV in people with Ebola Virus Disease, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China. 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?
- Ad5-EBOV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 60 years.
- African in China.
- 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 1 month).
- A body mass index (BMI) 18.5-35.0 kg/m2
- Hemoglobin ≥110g/L for female, and ≥120g/L for male.
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- 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
- Active partial thromboplastin time (APTT) 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
- Participant 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, 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
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China
This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.
Read the detailed description
This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV.
The whole follow-up period for each participant will be 28 days.
- Conditions
- Ebola Virus Disease
- Being tested
- Ad5-EBOV
- Keywords
- Vaccines, Ebola Virus Disease
- 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.
Ad5-EBOVBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| low dose | Experimental | 30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV). Receives: Biological: Ad5-EBOV |
| High dose | Experimental | After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV). Receives: Biological: Ad5-EBOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.
Measured: From March to July, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Institute of Bioengineering, Academy of Military Medical Sciences, Tianjin Cansino Biotechnology Inc
- Responsible party
- Principal investigator, Lanjuan Li, First Affiliated Hospital of Zhejiang University
- Investigators
- Lanjuan Li, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401373
- Sponsor's protocol ID
- GR2015VCT001
- Status last verified
- Jul 2015
- First submitted
- 24 Mar 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu L, Zhang Z, Gao H, Li Y, Hou L, Yao H, Wu S, Liu J, Wang L, Zhai Y, Ou H, Lin M, Wu X, Liu J, Lang G, Xin Q, Wu G, Luo L, Liu P, Shentu J, Wu N, Sheng J, Qiu Y, Chen W, Li L. Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Hum Vaccin Immunother. 2017 Sep 2;13(9):2078-2085. doi: 10.1080/21645515.2017.1342021. Epub 2017 Jul 14.
PubMed 28708962
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China
- ClinicalTrials.gov ID
- NCT02401373
- Acronym / sponsor ID
- GR2015VCT001
- Conditions
- Ebola Virus Disease
- Keywords
- Vaccines, Ebola Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Beijing Institute of Bioengineering, Academy of Military Medical Sciences, Tianjin Cansino Biotechnology Inc
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Mar 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.
This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.
Detailed description
This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV.
The whole follow-up period for each participant will be 28 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Biological: Ad5-EBOV30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV). |
| High dose | Experimental | Biological: Ad5-EBOVAfter the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Aged between 18 and 60 years.
- African in China.
- 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 1 month).
- A body mass index (BMI) 18.5-35.0 kg/m2
Key exclusion criteria (17 listed)
- Family history of seizure, epilepsy, brain or mental disease
- Participant 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, 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
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 |
|---|---|---|
| Ad5-EBOVintramuscular injection | Biological | High dose, low dose |
Primary outcome
A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China.
Time frame: From March to July, 2015
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 16 Jul 2015.
- Derived from this study: PubMed 28708962Wu L, Zhang Z, Gao H, Li Y, Hou L, Yao H, Wu S, Liu J, Wang L, Zhai Y, Ou H, Lin M, Wu X, Liu J, Lang G, Xin Q, Wu G, Luo L, Liu P, Shentu J, Wu N, Sheng J, Qiu Y, Chen W, Li L. Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Hum Vaccin Immunother. 2017 Sep 2;13(9):2078-2085. doi: 10.1080/21645515.2017.1342021. Epub 2017 Jul 14.
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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.
Lanjuan Li principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad5-EBOV in people with Ebola Virus Disease, run by First Affiliated Hospital of Zhejiang University 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 16 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 16 Jul 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. 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?
A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China. (time frame: From March to July, 2015). 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 NCT02401373, 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 16 Jul 2015.