Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS
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ClinicalTrials.gov Identifier: NCT01450280 |
Recruitment Status :
Completed
First Posted : October 12, 2011
Last Update Posted : November 29, 2012
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Sponsor:
University of Oxford
Information provided by (Responsible Party):
University of Oxford
Tracking Information | ||||
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First Submitted Date ICMJE | October 3, 2011 | |||
First Posted Date ICMJE | October 12, 2011 | |||
Last Update Posted Date | November 29, 2012 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety assessment of new candidate malaria vaccines ChAd63 CS [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ] To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.
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Original Primary Outcome Measures ICMJE |
Safety assessment of new candidate malaria vaccines ChAd63 CS [ Time Frame: Participants will be followed for the duration of the study, an expected average of 18 months ] To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Assessment of immune response induced by vaccination [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ] To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert.
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Original Secondary Outcome Measures ICMJE |
Assessment of immune response induced by vaccination [ Time Frame: Participants will be followed for the duration of the study, an expected average of 18 months ] To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert.
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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 New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS | |||
Official Title ICMJE | A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and With MVA CS | |||
Brief Summary | This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination. | |||
Detailed Description | Not Provided | |||
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: Prevention |
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Condition ICMJE | Malaria | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
24 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
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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 | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Ireland | |||
Removed Location Countries | United Kingdom | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01450280 | |||
Other Study ID Numbers ICMJE | VAC038 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University of Oxford | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University of Oxford | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of Oxford | |||
Verification Date | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |