| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Zika Chikungunya | Biological: ChAdOx1 Zika Biological: ChAdOx1 Zika, ChAdOx1 Chik | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Zika Virus (ZIKV) Vaccine ChAdOx1 Zika in Healthy Adult Volunteers Given as a Standalone Vaccine or Co-administered With the Chikungunya Virus (CHIKV) Candidate Vaccine ChAdOx1 Chik |
| Actual Study Start Date : | October 21, 2019 |
| Estimated Primary Completion Date : | March 2022 |
| Estimated Study Completion Date : | March 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Group 1
Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^9 vp vaccination intramuscularly.
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Biological: ChAdOx1 Zika
Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
|
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Experimental: Group 2
Volunteers will receive standalone dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination intramuscularly.
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Biological: ChAdOx1 Zika
Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
|
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Experimental: Group 3
Volunteers will receive standalone dose of ChAdOx1 Zika 5 x 10^10 vp vaccination intramuscularly.
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Biological: ChAdOx1 Zika
Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
|
|
Experimental: Group 4
Volunteers will receive co-administration dose of ChAdOx1 Zika 5 x 10^9 vp vaccination and ChAdOx1 Chik 5 x 10^9 vp intramuscularly.
|
Biological: ChAdOx1 Zika, ChAdOx1 Chik
Co-administration of ChAdOx1 Zika and ChAdOx1 Chik at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
|
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Experimental: Group 5
Volunteers will receive co-administration dose of ChAdOx1 Zika 2.5 x 10^10 vp vaccination and ChAdOx1 Chik 2.5 x 10^10 vp intramuscularly.
|
Biological: ChAdOx1 Zika, ChAdOx1 Chik
Co-administration of ChAdOx1 Zika and ChAdOx1 Chik at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
|
|
Experimental: Group 6
Volunteers will receive co-administration dose of ChAdOx1 Zika 5 x 10^10 vp vaccination and ChAdOx1 Chik 5 x 10^10 vp intramuscularly.
|
Biological: ChAdOx1 Zika, ChAdOx1 Chik
Co-administration of ChAdOx1 Zika and ChAdOx1 Chik at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
|
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Participants also Receiving ChAdOx1 Chik (Groups 4-6)
| Contact: Volunteer Recruitment Co-ordinator Volunteer Recruitment Co-ordinator | 01865 611424 | vaccinetrials@ndm.ox.ac.uk | |
| Contact: Adrian V Hill, DPhill FRCP |
| United Kingdom | |
| CCVTM, University of Oxford, Churchill Hospital | Recruiting |
| Oxford, United Kingdom, OX3 7LE | |
| Contact: Volunteer Recruitment Coordinator 01865 611424 vaccinetrials@ndm.ox.ac.uk | |
| Principal Investigator: | Adrian V Hill, DPhill FRCP | Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United Kingdom |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | June 4, 2019 | ||||||||
| First Posted Date ICMJE | July 11, 2019 | ||||||||
| Last Update Posted Date | April 14, 2021 | ||||||||
| Actual Study Start Date ICMJE | October 21, 2019 | ||||||||
| Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Immunogenicity of a Candidate ZIKV Vaccine (ZIKA001) | ||||||||
| Official Title ICMJE | A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Zika Virus (ZIKV) Vaccine ChAdOx1 Zika in Healthy Adult Volunteers Given as a Standalone Vaccine or Co-administered With the Chikungunya Virus (CHIKV) Candidate Vaccine ChAdOx1 Chik | ||||||||
| Brief Summary | This is a FIH, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 Zika vaccine in healthy volunteers given as a standalone vaccine or in coadministration with ChAdOx1 Chik. Both vaccines will be administered intramuscularly. | ||||||||
| Detailed Description | Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 6 study groups and a total of 48 volunteers will be enrolled. Groups 1-3 will receive ChAdOx1 Zika alone. Groups 4-6 will receive a co-administration of ChAdOx1 Zika and ChAdOx1 Chik administered contralaterally. Staggered enrolment will apply for the first three volunteers within each group. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
48 | ||||||||
| Original Estimated Enrollment ICMJE |
57 | ||||||||
| Estimated Study Completion Date ICMJE | March 2022 | ||||||||
| Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Participants also Receiving ChAdOx1 Chik (Groups 4-6)
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04015648 | ||||||||
| Other Study ID Numbers ICMJE | ZIKA001 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University of Oxford | ||||||||
| Study Sponsor ICMJE | University of Oxford | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Oxford | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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