Ebola Virus DiseasePhase 1NCT02485912
Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination
A Phase 1 study testing ChAd3-EBO Z and MVA-EBO Z in people with Ebola Virus Disease, run by University of Oxford at 1 site in Senegal.
Trial summary
This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen. 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
- What is being tested?
- ChAd3-EBO Z and MVA-EBO Z
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSenegal
- Study dates
- Jul 2015to Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative 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 participation during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, an MVA 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 23Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, (e.g. egg products) 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 current or previous psychiatric illness.
- 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 venepuncture
- Any other serious chronic illness
- 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)
- History of contact with suspected, probable or confirmed cases of Ebola in the previous 21 days
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A \& B)
- 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 Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years.
This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.
All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8 pfu.
Read more
All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7 days later.
The site of administration of the MVA-EBO Z vaccine differs between the two groups:
Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.
Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.
Read the detailed description
The CHUD study team will hold sensitisation meetings, in specific areas targeting specific populations, to explain the study to potential volunteers. During these meetings the investigators will explain the following: the need for a vaccine (including a simple picture of the burden of the Ebola disease and how it affects the community); the current status of vaccine development (including the fact that this is likely to be a prolonged process that probably will not influence the course of the current epidemic); the study screening and informed consent procedure; risks of vaccination and the unproven benefits of this vaccination. It will be stressed that this is an experimental vaccine and there is no current evidence that it will provide protection, and that it will therefore still be necessary to take preventive measures and to seek treatment if ill for any reason after vaccination.
After these sensitisation meetings, the CT team will actively identify. The study will be further explained to eligible participants on individual basis. Potential volunteers will be invited to the CHUD CT site for further discussion. Potential volunteers will be informed that they are free to withdraw from the CT at any time without giving any reason. Individuals who feel that the trial is appropriate for them will be invited to attend a formal screening visit.
Detailed information about the study will be provided in a Participant Information Sheet (PIS) at least 24 hours prior to the consent being undertaken. The informed consent process will start before the screening visit. The volunteer will be given the opportunity to ask about details of the trial, and will then have time to consider whether or not to participate. The investigators will ensure that the volunteers are briefed on the contents of the PIS in the language they understand. The investigators will also ensure that all volunteers fully understand the risks. Any volunteer who appears to have less than complete understanding will not be enrolled.
All volunteers will sign and date the informed consent form before any study specific procedures (including screening visit) are performed. If the volunteer is illiterate, s/he will sign the informed consent form; in the latter case a literate adult impartial witness will be present throughout the whole consenting process, write subject's name and date of signature and will sign and date the consent form. Volunteers will sign and date two copies of the consent form, one for them to take away and keep, and one to be stored in the subject's medical records.
Vaccinations in Group 1 can commence 7 days after vaccination after interim safety review of the first 5 volunteers receiving the same dose in the UK CT. The first 5 volunteers will be vaccinated in a staggered fashion.
The first volunteer to receive the ChAd63-EBO Z vaccine dose in Group 1 will be vaccinated alone and we will wait 24 hours before vaccinating subsequent volunteers in this group. Two further Group 1 volunteers will be vaccinated 24 hours after the first, and then at least another 24 hours gap will pass before vaccinating further subjects receiving the ChAd63-EBO Z vaccine in Groups 1 \& 2.
The same staggered vaccine administration procedure will be adopted for vaccinations with the MVA-EBO Z vaccine. A total of 20 volunteers will be enrolled in this group.
In Group 2, vaccination can commence after 5 volunteers in Groups 1 have received the ChAd63-EBO Z vaccine dose. The same staggered vaccine administration procedure as for Group 1 will be adopted for vaccinations with the MVA-EBO Z vaccine. A total of 20 volunteers will be enrolled in this group.
Volunteers will be visited daily at home by a study field worker or nurse to record adverse events (solicited and unsolicited for six consecutive days after vaccination). Additional scheduled visits at the CHUD clinic will be at day 7, 14, 28, 35, 56, 90, 180 post-first vaccination during which interim history will be collected, physical examination and blood tests performed at the time-points indicated in the schedule of attendances. Blood will also be taken for exploratory immunology analysis.
All volunteers will be followed up for 6 months beginning from the day of the first vaccination.
- Conditions
- Ebola Virus Disease
- Being tested
- ChAd3-EBO Z, MVA-EBO Z
- Keywords
- Ebola, vaccine, safety, immunogenicity
- 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.
ChAd3-EBO ZBiological
This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein
MVA-EBO ZBiological
This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm. Receives: Biological: ChAd3-EBO Z; Biological: MVA-EBO Z |
| Group 2 | Active comparator | ChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. Receives: Biological: ChAd3-EBO Z; Biological: MVA-EBO Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events.
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
The following parameters will be assessed for both groups:
- Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination
- Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination
- Occurrence of unsolicited adverse events for 28 days following the vaccination
- Change from baseline for safety laboratory measures
- Occurrence of serious adverse events during the whole study duration
Measured: 26 weeks
Secondary outcomes (1)
To Assess the Immunogenicity Generated by Heterologous Prime-boost Immunisation With Monovalent ChAd3-EBO Z (2.5 x 1010 vp - 3.7 x 1010vp) and MVA-EBO Z (1.0 x 108 Pfu) in Healthy Senegalese Volunteers Aged 18-50 Years
Ebolavirus specific immunogenicity will be assessed by a variety of immunological assays. The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses.
Exploratory outcome measures will include ex-vivo ELISPOT, plasma blast assays and flow cytometry performed with research samples collected at different study timepoints as well as other immunogenicity assays throughout the study. An evaluation of genetic factors associated with immune responses may be performed as exploratory evaluation. Vaccine-induced mRNA expression profiles during 1 week after vaccination may also be performed as an exploratory evaluation.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (47)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 OxfordThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
- Responsible party
- Sponsor
- Investigators
- Souleymane Mboup, MD; PhD, Principal investigator, Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485912
- Sponsor's protocol ID
- EBL06
- Status last verified
- Feb 2016
- First submitted
- 25 Jun 2015
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dixon MG, Schafer IJ; Centers for Disease Control and Prevention (CDC). Ebola viral disease outbreak--West Africa, 2014. MMWR Morb Mortal Wkly Rep. 2014 Jun 27;63(25):548-51.
PubMed 24964881Kuhn JH, Bao Y, Bavari S, Becker S, Bradfute S, Brister JR, Bukreyev AA, Chandran K, Davey RA, Dolnik O, Dye JM, Enterlein S, Hensley LE, Honko AN, Jahrling PB, Johnson KM, Kobinger G, Leroy EM, Lever MS, Muhlberger E, Netesov SV, Olinger GG, Palacios G, Patterson JL, Paweska JT, Pitt L, Radoshitzky SR, Saphire EO, Smither SJ, Swanepoel R, Towner JS, van der Groen G, Volchkov VE, Wahl-Jensen V, Warren TK, Weidmann M, Nichol ST. Virus nomenclature below the species level: a standardized nomenclature for natural variants of viruses assigned to the family Filoviridae. Arch Virol. 2013 Jan;158(1):301-11. doi: 10.1007/s00705-012-1454-0. Epub 2012 Sep 23.
PubMed 23001720Sanchez A, Kiley MP, Holloway BP, Auperin DD. Sequence analysis of the Ebola virus genome: organization, genetic elements, and comparison with the genome of Marburg virus. Virus Res. 1993 Sep;29(3):215-40. doi: 10.1016/0168-1702(93)90063-s.
PubMed 8237108Sanchez A, Kiley MP, Klenk HD, Feldmann H. Sequence analysis of the Marburg virus nucleoprotein gene: comparison to Ebola virus and other non-segmented negative-strand RNA viruses. J Gen Virol. 1992 Feb;73 ( Pt 2):347-57. doi: 10.1099/0022-1317-73-2-347.
PubMed 1538192Hart MK. Vaccine research efforts for filoviruses. Int J Parasitol. 2003 May;33(5-6):583-95. doi: 10.1016/s0020-7519(03)00064-x.
PubMed 12782057Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.
PubMed 15577929Meslin FX. Global aspects of emerging and potential zoonoses: a WHO perspective. Emerg Infect Dis. 1997 Apr-Jun;3(2):223-8. doi: 10.3201/eid0302.970220.
PubMed 9204308Okware SI, Omaswa FG, Zaramba S, Opio A, Lutwama JJ, Kamugisha J, Rwaguma EB, Kagwa P, Lamunu M. An outbreak of Ebola in Uganda. Trop Med Int Health. 2002 Dec;7(12):1068-75. doi: 10.1046/j.1365-3156.2002.00944.x.
PubMed 12460399Hensley LE, Jones SM, Feldmann H, Jahrling PB, Geisbert TW. Ebola and Marburg viruses: pathogenesis and development of countermeasures. Curr Mol Med. 2005 Dec;5(8):761-72. doi: 10.2174/156652405774962344.
PubMed 16375711Sullivan N, Yang ZY, Nabel GJ. Ebola virus pathogenesis: implications for vaccines and therapies. J Virol. 2003 Sep;77(18):9733-7. doi: 10.1128/jvi.77.18.9733-9737.2003. No abstract available.
PubMed 12941881Martin JE, Sullivan NJ, Enama ME, Gordon IJ, Roederer M, Koup RA, Bailer RT, Chakrabarti BK, Bailey MA, Gomez PL, Andrews CA, Moodie Z, Gu L, Stein JA, Nabel GJ, Graham BS. A DNA vaccine for Ebola virus is safe and immunogenic in a phase I clinical trial. Clin Vaccine Immunol. 2006 Nov;13(11):1267-77. doi: 10.1128/CVI.00162-06. Epub 2006 Sep 20.
PubMed 16988008Ledgerwood JE, Costner P, Desai N, Holman L, Enama ME, Yamshchikov G, Mulangu S, Hu Z, Andrews CA, Sheets RA, Koup RA, Roederer M, Bailer R, Mascola JR, Pau MG, Sullivan NJ, Goudsmit J, Nabel GJ, Graham BS; VRC 205 Study Team. A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults. Vaccine. 2010 Dec 16;29(2):304-13. doi: 10.1016/j.vaccine.2010.10.037. Epub 2010 Oct 27.
PubMed 21034824Yang ZY, Duckers HJ, Sullivan NJ, Sanchez A, Nabel EG, Nabel GJ. Identification of the Ebola virus glycoprotein as the main viral determinant of vascular cell cytotoxicity and injury. Nat Med. 2000 Aug;6(8):886-9. doi: 10.1038/78645.
PubMed 10932225Sullivan NJ, Geisbert TW, Geisbert JB, Shedlock DJ, Xu L, Lamoreaux L, Custers JH, Popernack PM, Yang ZY, Pau MG, Roederer M, Koup RA, Goudsmit J, Jahrling PB, Nabel GJ. Immune protection of nonhuman primates against Ebola virus with single low-dose adenovirus vectors encoding modified GPs. PLoS Med. 2006 Jun;3(6):e177. doi: 10.1371/journal.pmed.0030177. Epub 2006 May 16.
PubMed 16683867Bett AJ, Haddara W, Prevec L, Graham FL. An efficient and flexible system for construction of adenovirus vectors with insertions or deletions in early regions 1 and 3. Proc Natl Acad Sci U S A. 1994 Sep 13;91(19):8802-6. doi: 10.1073/pnas.91.19.8802.
PubMed 8090727
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Safety and Immunogenicity Clinical Trial of Heterologous Prime-boost Immunisation With ChAd3-EBO Z and MVA-EBO Z in Healthy Senegalese Adult Volunteers Aged 18-50 Years.
- ClinicalTrials.gov ID
- NCT02485912
- Acronym / sponsor ID
- EBL06
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola, vaccine, safety, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 6 Feb 2019
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 clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.
All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8 pfu.
All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7 days later.
The site of administration of the MVA-EBO Z vaccine differs between the two groups:
Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.
Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.
Detailed description
The CHUD study team will hold sensitisation meetings, in specific areas targeting specific populations, to explain the study to potential volunteers. During these meetings the investigators will explain the following: the need for a vaccine (including a simple picture of the burden of the Ebola disease and how it affects the community); the current status of vaccine development (including the fact that this is likely to be a prolonged process that probably will not influence the course of the current epidemic); the study screening and informed consent procedure; risks of vaccination and the unproven benefits of this vaccination. It will be stressed that this is an experimental vaccine and there is no current evidence that it will provide protection, and that it will therefore still be necessary to take preventive measures and to seek treatment if ill for any reason after vaccination.
After these sensitisation meetings, the CT team will actively identify. The study will be further explained to eligible participants on individual basis. Potential volunteers will be invited to the CHUD CT site for further discussion. Potential volunteers will be informed that they are free to withdraw from the CT at any time without giving any reason. Individuals who feel that the trial is appropriate for them will be invited to attend a formal screening visit.
Detailed information about the study will be provided in a Participant Information Sheet (PIS) at least 24 hours prior to the consent being undertaken. The informed consent process will start before the screening visit. The volunteer will be given the opportunity to ask about details of the trial, and will then have time to consider whether or not to participate. The investigators will ensure that the volunteers are briefed on the contents of the PIS in the language they understand. The investigators will also ensure that all volunteers fully understand the risks. Any volunteer who appears to have less than complete understanding will not be enrolled.
All volunteers will sign and date the informed consent form before any study specific procedures (including screening visit) are performed. If the volunteer is illiterate, s/he will sign the informed consent form; in the latter case a literate adult impartial witness will be present throughout the whole consenting process, write subject's name and date of signature and will sign and date the consent form. Volunteers will sign and date two copies of the consent form, one for them to take away and keep, and one to be stored in the subject's medical records.
Vaccinations in Group 1 can commence 7 days after vaccination after interim safety review of the first 5 volunteers receiving the same dose in the UK CT. The first 5 volunteers will be vaccinated in a staggered fashion.
The first volunteer to receive the ChAd63-EBO Z vaccine dose in Group 1 will be vaccinated alone and we will wait 24 hours before vaccinating subsequent volunteers in this group. Two further Group 1 volunteers will be vaccinated 24 hours after the first, and then at least another 24 hours gap will pass before vaccinating further subjects receiving the ChAd63-EBO Z vaccine in Groups 1 \& 2.
The same staggered vaccine administration procedure will be adopted for vaccinations with the MVA-EBO Z vaccine. A total of 20 volunteers will be enrolled in this group.
In Group 2, vaccination can commence after 5 volunteers in Groups 1 have received the ChAd63-EBO Z vaccine dose. The same staggered vaccine administration procedure as for Group 1 will be adopted for vaccinations with the MVA-EBO Z vaccine. A total of 20 volunteers will be enrolled in this group.
Volunteers will be visited daily at home by a study field worker or nurse to record adverse events (solicited and unsolicited for six consecutive days after vaccination). Additional scheduled visits at the CHUD clinic will be at day 7, 14, 28, 35, 56, 90, 180 post-first vaccination during which interim history will be collected, physical examination and blood tests performed at the time-points indicated in the schedule of attendances. Blood will also be taken for exploratory immunology analysis.
All volunteers will be followed up for 6 months beginning from the day of the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: ChAd3-EBO Z, Biological: MVA-EBO ZChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. Both vaccinations are administered in the same arm. |
| Group 2 | Active comparator | Biological: ChAd3-EBO Z, Biological: MVA-EBO ZChAd3-EBO Z (2.5 - 3.7 x 10^10 vp) and MVA-EBO Z (1.0 x 10^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative 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
Key exclusion criteria (23 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned participation during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, an MVA 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 |
|---|---|---|
| ChAd3-EBO ZThis is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein | Biological | Group 1, Group 2 |
| MVA-EBO ZThis is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein | Biological | Group 1, Group 2 |
Primary outcome
Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events.
Time frame: 26 weeks
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed for both groups: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety laboratory measures * Occurrence of serious adverse events during the whole study duration
1 secondary outcome
To Assess the Immunogenicity Generated by Heterologous Prime-boost Immunisation With Monovalent ChAd3-EBO Z (2.5 x 1010 vp - 3.7 x 1010vp) and MVA-EBO Z (1.0 x 108 Pfu) in Healthy Senegalese Volunteers Aged 18-50 Years
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24964881Dixon MG, Schafer IJ; Centers for Disease Control and Prevention (CDC). Ebola viral disease outbreak--West Africa, 2014. MMWR Morb Mortal Wkly Rep. 2014 Jun 27;63(25):548-51.
- Background: PubMed 23001720Kuhn JH, Bao Y, Bavari S, Becker S, Bradfute S, Brister JR, Bukreyev AA, Chandran K, Davey RA, Dolnik O, Dye JM, Enterlein S, Hensley LE, Honko AN, Jahrling PB, Johnson KM, Kobinger G, Leroy EM, Lever MS, Muhlberger E, Netesov SV, Olinger GG, Palacios G, Patterson JL, Paweska JT, Pitt L, Radoshitzky SR, Saphire EO, Smither SJ, Swanepoel R, Towner JS, van der Groen G, Volchkov VE, Wahl-Jensen V, Warren TK, Weidmann M, Nichol ST. Virus nomenclature below the species level: a standardized nomenclature for natural variants of viruses assigned to the family Filoviridae. Arch Virol. 2013 Jan;158(1):301-11. doi: 10.1007/s00705-012-1454-0. Epub 2012 Sep 23.
- Background: PubMed 8237108Sanchez A, Kiley MP, Holloway BP, Auperin DD. Sequence analysis of the Ebola virus genome: organization, genetic elements, and comparison with the genome of Marburg virus. Virus Res. 1993 Sep;29(3):215-40. doi: 10.1016/0168-1702(93)90063-s.
- Background: PubMed 1538192Sanchez A, Kiley MP, Klenk HD, Feldmann H. Sequence analysis of the Marburg virus nucleoprotein gene: comparison to Ebola virus and other non-segmented negative-strand RNA viruses. J Gen Virol. 1992 Feb;73 ( Pt 2):347-57. doi: 10.1099/0022-1317-73-2-347.
- Background: PubMed 12782057Hart MK. Vaccine research efforts for filoviruses. Int J Parasitol. 2003 May;33(5-6):583-95. doi: 10.1016/s0020-7519(03)00064-x.
- Background: PubMed 15577929Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.
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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.
Souleymane Mboup, MD; PhD principal investigator
Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal
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 ChAd3-EBO Z and MVA-EBO Z in people with Ebola Virus Disease, run by University of Oxford at 1 site in Senegal.
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 5 inclusion and 23 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 6 Feb 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 Senegal. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events. (time frame: 26 weeks). 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 NCT02485912, which also lists 47 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 6 Feb 2019.