Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE, United Kingdom
NCT Number: NCT01816113
This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Agreement to refrain from blood donation during the course of the study.
-Provide written informed consent.
Exclusion criteria
1 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly
1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly
1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly
1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly
Time frame: Up to 20 weeks post first vaccination
To assess the safety of ChAd63 PvDBP when administered alone and in heterologous prime-boost with MVA PvDBP. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study as well as abnormalities in Hematology and Biochemistry lab tests.
Time frame: U to 20 weeks post first vaccination.
PvDBP_RII-specific immunogenicity will be assessed by a variety of immunological assays. These may include ex vivo ELISpot assays for interferon gamma and flow cytometry assays, as well as antibody ELISAs. Other exploratory immunological assays including cytokine analysis, antibody assays, anti-adenovirus antibodies, DNA analysis of genetic polymorphisms potentially relevant to vaccine immunogenicity and gene expression studies amongst others may be performed at the discretion of the investigators.
Other exploratory immunology may be carried out in collaboration with other specialist labs, including labs outside of Europe. This would involve transfer of serum/plasma, but samples will be anonymised. Volunteers will be consented beforehand.
University of Oxford
Other
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Vivax Malaria Vaccine Candidates ChAd63 PvDBP Alone and With MVA PvDBP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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