| Autor: |
Rampling, T., Ewer, K.J., Bowyer, G., Bliss, C.M., Edwards, N.J., Wright, D., Payne, R., Venkatraman, N., de Barra, E., Snudden, C.M., Poulton, I.D., De Graaf, H., Sukhtankar, P., Roberts, R., Ivinson, K., Weltzin, R., Rajkimar, B.-Y., Wille-Reece, U., Lee, C., Ockenhouse, C., Sinden, R.E., Gerry, S., Lawrie, A.M., Vekemans, J., Morelle, D., Lievens, M., Ballou, R.W., Cooke, G.S., Faust, S.N., Gilbert, S., Hill, A.V.S. |
| Jazyk: |
angličtina |
| Rok vydání: |
2016 |
| Předmět: |
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| Popis: |
BACKGROUND: The need for a highly efficacious vaccine against Plasmodium falciparum remains pressing. In this controlled human malaria infection (CHMI) study, we assessed the safety, efficacy and immunogenicity of a schedule combining two distinct vaccine types in a staggered immunization regimen: one inducing high-titer antibodies to CSP (RTS,S/AS01B) and the other inducing potent T-cell responses to TRAP using viral vectors. METHOD: 37 healthy malaria-naïve adults were vaccinated with either ChAd63-MVA expressing ME-TRAP and 3 doses of RTS,S/AS01B (Group 1, n=20) or 3 doses of RTS,S/AS01B alone (Group 2, n=17). CHMI was delivered by mosquito bites in 33 vaccinated subjects at week 12 after first vaccination, and 6 unvaccinated controls. RESULTS: No SUSAR or SAEs related to vaccination were reported. Protective vaccine efficacy was observed in 14/17 (82.4%) subjects in Group 1 and 12/16 (75%) subjects in Group 2. All control subjects were diagnosed with blood stage malaria. Both vaccination regimens were immunogenic. 14 protected subjects underwent repeat CHMI 6 months after initial CHMI; 7/8 (87.5%) Group 1 subjects and 5/6 (83.3%) Group 2 subjects remained protected. CONCLUSION: The high level of sterile efficacy observed in this trial is encouraging for further evaluation of combination approaches using these vaccine types.Clinicaltrials.gov Registration. NCT01883609. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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