Experimental infection and protection against ... - TI Pharma
Experimental infection and protection against ... - TI Pharma
Experimental infection and protection against ... - TI Pharma
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Introduction 11<br />
Preclinical Clinical<br />
Phase 1A Phase 1B Phase 2A Phase 2B Phase 3<br />
Aim Safety, dose, efficacy, long-term Safety & Safety & Efficacy & Efficacy & Adverse<br />
effects<br />
dose dose side effects side effects reactions<br />
<strong>and</strong> longterm<br />
Population Rodent <strong>and</strong>/or simian Non- Endemic Non- Endemic Endemic<br />
endemicendemic<br />
Duration 3-6 years 3-12 3-12 3-24 3-24 3 years<br />
months months months months<br />
Typical size of<br />
~10 ~10 ~10 100-300 10,000test<br />
group<br />
RTS,S/AS01E<br />
AdCh63/MVA ME-TRAP<br />
PfSPZ: metabolically active, nonreplicating<br />
malaria sporozoite vaccine<br />
Adenovirus (Ad35) vectored CS<br />
polyepitope DNA EP1300<br />
CSVAC<br />
Pf CelTOS FMP012<br />
Ad35.CS.01/Ad26.CS.01<br />
(Heterologous adenovirus primeboost<br />
strategy)<br />
Two-component paediatric malaria<br />
vaccine (CS)<br />
Pf GAP p52-/p32- (Genetically<br />
Attenuated Sporozoites)<br />
RTS,S/AS02A<br />
DNA/MVA prime-boost Multi-Epitope<br />
(ME) string + TRAP<br />
FP9 MVA prime-boost ME-TRAP<br />
FP9 CSP + LSA-1 epitope/ MVA-CSP +<br />
LSA-1 epitope<br />
MuStDO5 (Multi-Stage DNA vaccine<br />
Operation, 5 antigens)<br />
NMRC-MV-Ad-PfC<br />
CSP long synthetic peptide<br />
LSA-3 (inactive)<br />
FMP011/AS01B (LSA-1 E. coliexpressed<br />
in AS01B adjuvant)<br />
FMP011/AS02A (LSA-1 E. coliexpressed<br />
in AS02A adjuvant)<br />
DNA/MVA CSP<br />
HepB Core-Ag CSP VLP<br />
RTS,S/AS02 <strong>and</strong> SSP2/TRAP<br />
RTS,S/AS02 <strong>and</strong> MVA CSP<br />
RTS,S/AS02 <strong>and</strong> DNA CSP<br />
CSP DNA immunization<br />
50,000<br />
Pre-erythrocytic vaccine c<strong>and</strong>idates<br />
Figure 2: Malaria vaccines in (pre-)clinical development. Vaccines in lighter shades have<br />
stopped or halted in development. [16]<br />
[7]. Current efforts should thus be supplemented with a structured research<br />
agenda taking a multidisciplinary global approach [9]. An effective malaria<br />
vaccine is a key tool of critical research that is needed to support malaria control<br />
<strong>and</strong> eradication [9]. Ambitious goals in this regard have been set by the Malaria<br />
Vaccine Technology Roadmap, which aims to develop <strong>and</strong> license a malaria<br />
vaccine with more than 80% protective efficacy <strong>against</strong> clinical disease that lasts<br />
longer than four years, by the year 2025 [10]. However, despite extensive
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