Malaria vaccines under different phases of clinical trial

on

 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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