Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with chimpanzee adenovirus 63 and modified vaccinia ankara vectored vaccines expressing ME-TRAP
| Autor: | Rampling, T., Ewer, K.J., Bowyer, G., Bliss, C.M., Edwards, N.J., Wright, D., Payne, R.O., Venkatraman, N., de Barra, E., Snudden, C.M., Poulton, I.D., de Graaf, H., Sukhtankar, P., Roberts, R., Ivinson, K., Weltzin, R., Rajkumar, B.-Y., Wille-Reece, U., Lee, C.K., Ockenhouse, C.F., 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. |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Adolescent Drug-Related Side Effects and Adverse Reactions Protozoan Proteins malaria Vaccinia virus ChAd63 P. falciparum Adenoviridae Young Adult Major Articles and Brief Reports vaccine Malaria Vaccines RTS S parasitic diseases Animals Humans Parasites Vaccines Combined Malaria Falciparum Immunization Schedule Drug Carriers Vaccines Synthetic ME-TRAP Middle Aged Healthy Volunteers Treatment Outcome Female |
| Zdroj: | The Journal of Infectious Diseases |
| ISSN: | 0022-1899 |
| Popis: | Background. The need for a highly efficacious vaccine against Plasmodium falciparum remains pressing. In this controlled\ud human malaria infection (CHMI) study, we assessed the safety, efficacy and immunogenicity of a schedule combining 2 distinct\ud vaccine types in a staggered immunization regimen: one inducing high-titer antibodies to circumsporozoite protein (RTS,S/\ud AS01B) and the other inducing potent T-cell responses to thrombospondin-related adhesion protein (TRAP) by using a viral vector.\ud Method. Thirty-seven healthy malaria-naive adults were vaccinated with either a chimpanzee adenovirus 63 and modified vaccinia\ud virus Ankara–vectored vaccine expressing a multiepitope string fused to TRAP and 3 doses of RTS,S/AS01B (group 1; n = 20) or\ud 3 doses of RTS,S/AS01B alone (group 2; n = 17). CHMI was delivered by mosquito bites to 33 vaccinated subjects at week 12 after the\ud first vaccination and to 6 unvaccinated controls.\ud Results. No suspected unexpected serious adverse reactions or severe adverse events related to vaccination were reported.\ud Protective vaccine efficacy was observed in 14 of 17 subjects (82.4%) in group 1 and 12 of 16 subjects (75%) in group 2. All control\ud subjects received a diagnosis of blood-stage malaria parasite infection. Both vaccination regimens were immunogenic. Fourteen\ud protected subjects underwent repeat CHMI 6 months after initial CHMI; 7 of 8 (87.5%) in group 1 and 5 of 6 (83.3%) in group\ud 2 remained protected.\ud Conclusions. The high level of sterile efficacy observed in this trial is encouraging for further evaluation of combination\ud approaches using these vaccine types. |
| Databáze: | OpenAIRE |
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