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Vaccine Detail
ChAd63-MVA ME-TRAP |
Vaccine Information |
- Vaccine Name: ChAd63-MVA ME-TRAP
- Target Pathogen: Plasmodium spp.
- Target Disease: Malaria
- Type: Recombinant vector vaccine
- Status: Clinical trial
- Host Species for Licensed Use: Human
- Antigen: ME-TRAP: multiple epitope thrombospondin-related adhesion protein of the pre-erythrocyte stage P.falciparum (Mensah et al., 2016)
- TRAP from P. falciparum
gene engineering:
- Type: Recombinant vector construction
- Description:
- Detailed Gene Information: Click Here.
- Immunization Route: Intramuscular injection (i.m.)
- Description: Prime-boosting vaccine that use different vectors: ChAd63 ME-TRAP is the prime vaccination and MVA ME-TRAP is the booster.
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Host Response |
Human Response
- Host Strain: Healthy men aged 18–50 years old in the peri-urban area of Dakar in Senegal, West Africa.
- Vaccination Protocol: Random, controlled, single-blinded phase IIb efficacy trial.
Participants radomly receive either 1) ChAd63 ME-TRAP (5x105 vp) as prime vaccination and MVA ME-TRAP (2x108 pfu) as booster eight weeks later or 2) two doses of anti-rabies vaccine (0.5ml) at the same interval. (Mensah et al., 2016)
- Immune Response: Increases in anti-TRAP IgG responses.
Cellular immunogenicity: TRAP-specific T cells induced 14 days after prime vaccination: 261 SFC per million PBMC (95% CI 165–412) compared with 48 SFC (95% CI 30–79 SFC) in control group. 7 days after booster: 932 SFC (95% CI 754–1152) compared with 57 SFC per million (95% CI 44–72) in control group. Humoral: TRAP peptide pools 1, 2, 3 and 6 frequently recognized: 66–93% positive response to these pools at the peak time point after MVA in TRAP group, comparing with 19% positive response to pool 3 and 10% positive response to pool 1 in control group. Positive correlation between humoral and cellular immunogenicity. Neutralising antibodies to the ChAd63 vector detected: LGMT of 216 (95% CI 188–247), 56% responses above the clinically relevant threshold of 200.(Mensah et al., 2016)
- Side Effects: ChAd63: Solicited local AEs: Mild or moderate pain, itching, redness, swelling, and warmth. Systematic AEs: fever, myalgia, discomfort, headache, arthralgia, and nausea.
MVA: more reactogenic than ChAd63, but still tolerable for the majority. Solicited local AEs: swelling, pain, itching, and warmth (last between a few hours to 2 days). Systematic AEs: arthralgia, fever, headache, myalgia, nausea, and discomfort (Mensah et al., 2016)
- Efficacy: PCR positive cases:12 of 57 in TRAP group, 13 of 58 in controls: 8% efficacy, but not statistically significant.
Malaria cases: 11 in TRAP group, 12 in control group: unadjusted efficacy of 9%, non-significant. *protocol-specified metaanalysis after pooling the data of the Kenyan and Senegalese trials showed significant protective efficacy of 50% (95% CI 17%-70%). (Mensah et al., 2016)
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References |
Mensah et al., 2016: Mensah VA, Gueye A, Ndiaye M, Edwards NJ, Wright D, Anagnostou NA, Syll M, Ndaw A, Abiola A, Bliss C, Gomis JF, Petersen I, Ogwang C, Dieye T, Viebig NK, Lawrie AM, Roberts R, Nicosia A, Faye B, Gaye O, Leroy O, Imoukhuede EB, Ewer KJ, Bejon P, Hill AV, Cisse B. Safety, Immunogenicity and Efficacy of Prime-Boost Vaccination with ChAd63 and MVA Encoding ME-TRAP against Plasmodium falciparum Infection in Adults in Senegal. PloS one. 2016; 11(12); e0167951. [PubMed: 27978537].
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