Ebola Virus DiseasePhase 1NCT02267109
Phase 1 Trial of Ebola Vaccine in Mali
A Phase 1 study testing Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z in people with Ebola Virus Disease and Hemorrhagic Fever, run by University of Maryland, Baltimore at 1 site in Mali.
Trial summary
Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease, Hemorrhagic Fever
- What is being tested?
- Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteMali
- Study dates
- Oct 2014to 20 Apr 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with his/her health care provider
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative urine pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Who cannot join
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, MVA vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
- Receipt of any live, attenuated vaccine within 28 days prior to enrolment
- Receipt of any subunit or killed vaccine within 14 days prior to enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
Show all 24Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including urticaria, respiratory difficulty or abdominal pain
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- Any history of anaphylaxis in reaction to vaccination
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- Poorly controlled asthma or thyroid disease
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
- Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
- Any known history of cardiac disease
- Any other serious chronic illness requiring hospital specialist supervision
- Current anti-tuberculosis prophylaxis or therapy
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Seropositive for hepatitis B surface antigen (HBsAg)
- Travel to an Ebola or Marburg endemic region during the study period or within the previous six months or history of recovery from Ebola or Marburg virus disease.
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Dose-escalating Safety and Immunogenicity Trial of the Novel Monovalent Ebola Zaire Candidate Vaccine, cAd3-EBO Z and the Heterologous Prime-boost Candidate Vaccine Regimen of cAD3-EBO Z Followed by MVA-BN® Filo in Malian Adults Aged 18-50 Years.
Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.
Read the detailed description
This is a Phase 1b (1b implies that the trial is occurring in a geographic region where cases of the disease against which the vaccine is directed, i.e. Ebola disease, may occur before, during or after the clinical trial), open label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola virus vaccine, cAD3-EB) Z, in Malian healthy adults. The vaccine is a recombinant chimpanzee adenovirus Type-3 vectored Ebola Zaire vaccine (cAd3-EBO Z) and consists of a recombinant replication-deficient adenovirus chimpanzee serotype 3 (cAd3) vector expressing wild-type (WT) Ebola glycoprotein (GP) from the Zaire strain.
A revision of the protocol on 14Dec2014 added a booster dose with MVA-BN® Filo or placebo in 56 subjects in groups 1 (except for first 5 vaccines), 2, 3A and 4. The multivalent vectored vaccine MVA-BN® Filo contains an insert for the Zaire Ebola virus glycoprotein, as well as the Sudan strain Ebola virus glycoprotein, the Musoke strain Marburg virus glycoprotein, and a nucleoprotein from the Tai-Forest Ebola virus.
Forty volunteers will be enrolled into two dosage groups. Another group of 40 volunteers (Groups 3A-C) with group 3A receiving 1.0x10(10)vp. All study participants will receive one dose of the study vaccine by intramuscular injection. Group 4 was added to include another 11 volunteers to receive 1.-X10(11)vp. A total of 91 volunteers have been included.
Group 1 will include 20 participants who will receive the lower dose of the vaccine at 2.5 x 10(10) vp
Group 2 will include 20 participants who will receive the higher does of vaccine at 5 x 10(10) vp.
Group 3A will include 10 participants to receive 1.0X10(10) vp
Group 3B will include 15 participants to receive 2.5X10(10) vp
Group 3C will include 15 participants to receive 5X10(10) vp (participants will be randomly allocated to Group 3B or 3C)
Group 4 will include 11 participants to receive1x10(11) vp. The goal of vaccinating this group is to see if there is any added benefit to the immunogenicity of this vaccine by using a higher dose. This dosage level of the monovalent vaccine has already been studied at VRC/NIH in September and at CVD in Baltimore this month in November. This dosage level was not studied in Oxford nor in Bamako. Having data on West African subjects given this dosage will be very helpful in designing the final formulation for the field trials in Q1 of 2015. The decision will be made based on three sets of data: clinical dose-response; immunologic dose-response (as a proxy for expected protection); and manufacturing yield and cost of goods considerations.
For safety reasons, the first Malian volunteer to receive a vaccine dose in Group 1 will be vaccinated alone and we will wait 24 hours before vaccinating subsequent volunteers in this dose group. Two further Group 1 volunteers may be vaccinated 24 hours after the first, and then at least another 24 hours gap will be left before vaccinating further subjects receiving that dose of vaccine. After 5 volunteers in Group 1 have been vaccinated and followed up for 7 days, an interim safety review (ISR1) will be performed by the DSMB. Enrollment of the rest of this group may proceed only if the DSMB assesses the data and indicates that it is safe to do so.
Group 2 volunteers will be vaccinated without the stepwise procedure. This decision was made by the DSMB after review of safety data for 5X10(10) from the UK trial and approval by the Institutional Review Boards.
Group 3A, who will receive a lower dosage level than Groups 1 or 2, can be vaccinated as soon as logistically possible after all subjects in Group 2 have been vaccinated. Groups 3B and Group 3C will be similarly vaccinated over a period of three days at the rate of 10 subjects per day.
Group 4 will vaccinate and additional 11 participants with 1X10(11) and will be vaccinated over 2 days (5 subjects one day followed by another 6 subjects the next day.
Heterologous boosting dose of MVA-BN® Filo or placebo in 56 subjects in groups 1 (except for first 5 vaccinees), 2, 3A and 4 will commence in January 2015 with random allocation to either vaccine or placebo.
- Conditions
- Ebola Virus Disease, Hemorrhagic Fever
- Being tested
- Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z, Booster-MVA-BN® Filo or saline placebo
- Medical subject headings
- Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO ZBiological
Also called cAd3-EBO Z:
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
Booster-MVA-BN® Filo or saline placeboBiological
IM injection of Booster-MVA-BN® Filo or saline placebo
| Study group | Role | What they receive |
|---|---|---|
| 2.5 x 10(10) vp | Experimental | Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 2.5 x 10(10): Receives: Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z; Biological: Booster-MVA-BN® Filo or saline placebo |
| 5 x 10(10) vp | Experimental | Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 5 x 10(10): Receives: Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z; Biological: Booster-MVA-BN® Filo or saline placebo |
| 1.0 x 10(10) vp | Experimental | Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(10): Receives: Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z; Biological: Booster-MVA-BN® Filo or saline placebo |
| 1.0 x 10(11) vp | Experimental | Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(11): Receives: Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z; Biological: Booster-MVA-BN® Filo or saline placebo |
| Booster-MVA-BN® Filo or saline placebo | Experimental | MVA-BN® Filo or saline placebo Receives: Biological: Booster-MVA-BN® Filo or saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and systemic reactogenicity signs and symptoms
Measured: Daily for 7 days following each vaccination.
Occurrence of unsolicited adverse events
Measured: 28 days following the vaccination
Change from baseline for safety laboratory measures
Measured: 6 months for each volunteer
Occurrence of serious adverse events and incident chronic medical conditions
Measured: 6 months for each volunteer
Secondary outcomes (2)
Antibody responses as measured by ELISA and neutralization assays
Measured: Day 1, 7, 14, 28, 90 and 180 after vaccination
T cell immune responses as measured by intracellular cytokine staining assay
Measured: Day 1, 7 and 14 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion20 Apr 2016
- Study completion20 Apr 2016
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 University of Maryland, BaltimoreThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute of Allergy and Infectious Diseases (NIAID), Leidos Biomedical Research, Inc.
- Responsible party
- Principal investigator, Milagritos Tapia, University of Maryland, Baltimore
- Investigators
- Myron M Levine, MD, DTPH, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267109
- Sponsor's protocol ID
- HP-00061513
- Status last verified
- Sep 2019
- First submitted
- 3 Oct 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tapia MD, Sow SO, Lyke KE, Haidara FC, Diallo F, Doumbia M, Traore A, Coulibaly F, Kodio M, Onwuchekwa U, Sztein MB, Wahid R, Campbell JD, Kieny MP, Moorthy V, Imoukhuede EB, Rampling T, Roman F, De Ryck I, Bellamy AR, Dally L, Mbaya OT, Ploquin A, Zhou Y, Stanley DA, Bailer R, Koup RA, Roederer M, Ledgerwood J, Hill AVS, Ballou WR, Sullivan N, Graham B, Levine MM. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2016 Jan;16(1):31-42. doi: 10.1016/S1473-3099(15)00362-X. Epub 2015 Nov 4.
PubMed 26546548
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Dose-escalating Safety and Immunogenicity Trial of the Novel Monovalent Ebola Zaire Candidate Vaccine, cAd3-EBO Z and the Heterologous Prime-boost Candidate Vaccine Regimen of cAD3-EBO Z Followed by MVA-BN® Filo in Malian Adults Aged 18-50 Years.
- ClinicalTrials.gov ID
- NCT02267109
- Acronym / sponsor ID
- HP-00061513
- Conditions
- Ebola Virus Disease, Hemorrhagic Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute of Allergy and Infectious Diseases (NIAID), Leidos Biomedical Research, Inc.
- Study start
- Oct 2014 (actual)
- Primary completion
- 20 Apr 2016 (actual)
- Study completion
- 20 Apr 2016 (actual)
- First posted
- 17 Oct 2014 (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.
Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.
Detailed description
This is a Phase 1b (1b implies that the trial is occurring in a geographic region where cases of the disease against which the vaccine is directed, i.e. Ebola disease, may occur before, during or after the clinical trial), open label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola virus vaccine, cAD3-EB) Z, in Malian healthy adults. The vaccine is a recombinant chimpanzee adenovirus Type-3 vectored Ebola Zaire vaccine (cAd3-EBO Z) and consists of a recombinant replication-deficient adenovirus chimpanzee serotype 3 (cAd3) vector expressing wild-type (WT) Ebola glycoprotein (GP) from the Zaire strain.
A revision of the protocol on 14Dec2014 added a booster dose with MVA-BN® Filo or placebo in 56 subjects in groups 1 (except for first 5 vaccines), 2, 3A and 4. The multivalent vectored vaccine MVA-BN® Filo contains an insert for the Zaire Ebola virus glycoprotein, as well as the Sudan strain Ebola virus glycoprotein, the Musoke strain Marburg virus glycoprotein, and a nucleoprotein from the Tai-Forest Ebola virus.
Forty volunteers will be enrolled into two dosage groups. Another group of 40 volunteers (Groups 3A-C) with group 3A receiving 1.0x10(10)vp. All study participants will receive one dose of the study vaccine by intramuscular injection. Group 4 was added to include another 11 volunteers to receive 1.-X10(11)vp. A total of 91 volunteers have been included.
Group 1 will include 20 participants who will receive the lower dose of the vaccine at 2.5 x 10(10) vp
Group 2 will include 20 participants who will receive the higher does of vaccine at 5 x 10(10) vp.
Group 3A will include 10 participants to receive 1.0X10(10) vp
Group 3B will include 15 participants to receive 2.5X10(10) vp
Group 3C will include 15 participants to receive 5X10(10) vp (participants will be randomly allocated to Group 3B or 3C)
Group 4 will include 11 participants to receive1x10(11) vp. The goal of vaccinating this group is to see if there is any added benefit to the immunogenicity of this vaccine by using a higher dose. This dosage level of the monovalent vaccine has already been studied at VRC/NIH in September and at CVD in Baltimore this month in November. This dosage level was not studied in Oxford nor in Bamako. Having data on West African subjects given this dosage will be very helpful in designing the final formulation for the field trials in Q1 of 2015. The decision will be made based on three sets of data: clinical dose-response; immunologic dose-response (as a proxy for expected protection); and manufacturing yield and cost of goods considerations.
For safety reasons, the first Malian volunteer to receive a vaccine dose in Group 1 will be vaccinated alone and we will wait 24 hours before vaccinating subsequent volunteers in this dose group. Two further Group 1 volunteers may be vaccinated 24 hours after the first, and then at least another 24 hours gap will be left before vaccinating further subjects receiving that dose of vaccine. After 5 volunteers in Group 1 have been vaccinated and followed up for 7 days, an interim safety review (ISR1) will be performed by the DSMB. Enrollment of the rest of this group may proceed only if the DSMB assesses the data and indicates that it is safe to do so.
Group 2 volunteers will be vaccinated without the stepwise procedure. This decision was made by the DSMB after review of safety data for 5X10(10) from the UK trial and approval by the Institutional Review Boards.
Group 3A, who will receive a lower dosage level than Groups 1 or 2, can be vaccinated as soon as logistically possible after all subjects in Group 2 have been vaccinated. Groups 3B and Group 3C will be similarly vaccinated over a period of three days at the rate of 10 subjects per day.
Group 4 will vaccinate and additional 11 participants with 1X10(11) and will be vaccinated over 2 days (5 subjects one day followed by another 6 subjects the next day.
Heterologous boosting dose of MVA-BN® Filo or placebo in 56 subjects in groups 1 (except for first 5 vaccinees), 2, 3A and 4 will commence in January 2015 with random allocation to either vaccine or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2.5 x 10(10) vp | Experimental | Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z, Biological: Booster-MVA-BN® Filo or saline placeboEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 2.5 x 10(10): |
| 5 x 10(10) vp | Experimental | Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z, Biological: Booster-MVA-BN® Filo or saline placeboEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 5 x 10(10): |
| 1.0 x 10(10) vp | Experimental | Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z, Biological: Booster-MVA-BN® Filo or saline placeboEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(10): |
| 1.0 x 10(11) vp | Experimental | Biological: Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z, Biological: Booster-MVA-BN® Filo or saline placeboEbola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z) 1.0 x 10(11): |
| Booster-MVA-BN® Filo or saline placebo | Experimental | Biological: Booster-MVA-BN® Filo or saline placeboMVA-BN® Filo or saline placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with his/her health care provider
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative urine pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (24 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, MVA vectored vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
- Receipt of any live, attenuated vaccine within 28 days prior to enrolment
- Receipt of any subunit or killed vaccine within 14 days prior to enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
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 Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO ZAlso: cAd3-EBO Z:IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z): | Biological | 1.0 x 10(10) vp, 1.0 x 10(11) vp, 2.5 x 10(10) vp, 5 x 10(10) vp |
| Booster-MVA-BN® Filo or saline placeboIM injection of Booster-MVA-BN® Filo or saline placebo | Biological | 1.0 x 10(10) vp, 1.0 x 10(11) vp, 2.5 x 10(10) vp, 5 x 10(10) vp, Booster-MVA-BN® Filo or saline placebo |
Primary outcome
Occurrence of solicited local and systemic reactogenicity signs and symptoms
Time frame: Daily for 7 days following each vaccination.
Occurrence of unsolicited adverse events
Time frame: 28 days following the vaccination
Change from baseline for safety laboratory measures
Time frame: 6 months for each volunteer
Occurrence of serious adverse events and incident chronic medical conditions
Time frame: 6 months for each volunteer
2 secondary outcomes
Antibody responses as measured by ELISA and neutralization assays
Time frame: Day 1, 7, 14, 28, 90 and 180 after vaccination
T cell immune responses as measured by intracellular cytokine staining assay
Time frame: Day 1, 7 and 14 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 26 Sep 2019.
- Derived from this study: PubMed 26546548Tapia MD, Sow SO, Lyke KE, Haidara FC, Diallo F, Doumbia M, Traore A, Coulibaly F, Kodio M, Onwuchekwa U, Sztein MB, Wahid R, Campbell JD, Kieny MP, Moorthy V, Imoukhuede EB, Rampling T, Roman F, De Ryck I, Bellamy AR, Dally L, Mbaya OT, Ploquin A, Zhou Y, Stanley DA, Bailer R, Koup RA, Roederer M, Ledgerwood J, Hill AVS, Ballou WR, Sullivan N, Graham B, Levine MM. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2016 Jan;16(1):31-42. doi: 10.1016/S1473-3099(15)00362-X. Epub 2015 Nov 4.
- Individual participant dataSharing planned: No
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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.
Myron M Levine, MD, DTPH study director
University of Maryland, Baltimore
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 Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z in people with Ebola Virus Disease and Hemorrhagic Fever, run by University of Maryland, Baltimore at 1 site in Mali.
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 24 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 26 Sep 2019. 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 Mali. 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?
Occurrence of solicited local and systemic reactogenicity signs and symptoms (time frame: Daily for 7 days following each 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?
On the ClinicalTrials.gov record for NCT02267109, 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 26 Sep 2019.