Table 2: Lists of vaccines under pre-clinical and clinical trials
|
Phases |
Characteristics /Criteria |
Examples of Vaccines |
|
|
|
|
|
Preclinical phase |
·
Animal models ·
Choice of relevant animals ·
Selection of Adjuvants ·
Immunogenicity studies ·
Animal Safety studies ·
Potency assay |
·
All the vaccines in the clinical trials
must be succeed through the preclinical trails |
|
|
||
|
Clinical Phases |
||
|
Phase Ia |
·
to provide a preliminary evaluation on safety and
immunogenicity of the vaccine candidate ·
To demonstrate local and systemic reactions
(reactogenicity) |
·
ChAd63/MVA ME-TRAP + ·
PfXelTOS FMP012 ·
PfPEBS ·
ChAd63/MVA PVDBP ·
Pfs25-VLP ·
Polyepitope DNA EP 1300 |
|
Phase Ib |
·
To gather information on safety and to observe the
immune response after vaccine candidate administration. |
·
Pfs25-EPA ·
AMA1-DiCo ·
P27A ·
EBA 175.R2 ·
MSP3-LSP ·
BK-SE36 ·
PAMVAC ·
PRIMVAC ·
PfPEBS |
|
|
||
|
Phase IIa |
·
Optimize the vaccine dose ·
The number of vaccine doses needed to elicit a proper
immune ·
response (antibodies active with regard to clinical
endpoints), ·
The need for an adjuvant and choice of the adjuvant. ·
The need for booster doses ·
The administration route: injectable
(intramuscular/subcutaneous/ intradermal) or mucosal (oral, intranasal). ·
The induction of an immune memory and the reactivation
kinetics of memory-B cells. |
·
RTS,S-AS01 ChAd63/MVA ME-TRAP ·
RTS,S-AS01 fractional dose ·
GMZ2 ·
MSP3 [181-276] ·
Ad35.CS/Ad26.CS ·
ChAd63/MVA (CS, TRAP, AMA) |
|
|
||
|
Phase IIb |
·
to evaluate the preliminary efficacy of the vaccine
candidate before the initiation of a pivotal phase 3 trial ·
Adverse effects |
·
ChAd63/MVA ME-TRAP ·
PfSPZ ·
R21/ME-TRAP |
|
|
||
|
Phase III |
·
To determine the efficacy and safety in
target population |
·
RTS,S-AS01 |
|
|
||
|
Pilot Study |
·
Quality, safety and efficacy ·
Cost effectivity ·
Marketing |
·
RTS,S-AS01 |
(Source: WHO, Background paper on the
RTS,S/AS01 malaria vaccine-2015, Frimpong
et al., 2018, Salamanca et al., 2019, Artaud et al., 2019)
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