Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP
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: o...
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Oxford University Press
2016
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| _version_ | 1826260174134837248 |
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| author | Rampling, T Ewer, K Bowyer, G Bliss, C Edwards, N Wright, D Payne, R Venkatraman, N Snudden, C Poulton, I Roberts, R Sinden, R Gerry, S Lawrie, A Gilbert, S Hill, A |
| author_facet | Rampling, T Ewer, K Bowyer, G Bliss, C Edwards, N Wright, D Payne, R Venkatraman, N Snudden, C Poulton, I Roberts, R Sinden, R Gerry, S Lawrie, A Gilbert, S Hill, A |
| author_sort | Rampling, T |
| collection | OXFORD |
| description | 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. <br/> 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. <br/> 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. <br/> Conclusion: The high level of sterile efficacy observed in this trial is encouraging for further evaluation of combination approaches using these vaccine types. |
| first_indexed | 2024-03-06T19:01:27Z |
| format | Journal article |
| id | oxford-uuid:13aac41a-a5f6-4047-9e90-11fdf4ad5a8a |
| institution | University of Oxford |
| last_indexed | 2024-03-06T19:01:27Z |
| publishDate | 2016 |
| publisher | Oxford University Press |
| record_format | dspace |
| spelling | oxford-uuid:13aac41a-a5f6-4047-9e90-11fdf4ad5a8a2022-03-26T10:15:11ZSafety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAPJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:13aac41a-a5f6-4047-9e90-11fdf4ad5a8aSymplectic Elements at OxfordOxford University Press2016Rampling, TEwer, KBowyer, GBliss, CEdwards, NWright, DPayne, RVenkatraman, NSnudden, CPoulton, IRoberts, RSinden, RGerry, SLawrie, AGilbert, SHill, ABackground: 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. <br/> 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. <br/> 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. <br/> Conclusion: The high level of sterile efficacy observed in this trial is encouraging for further evaluation of combination approaches using these vaccine types. |
| spellingShingle | Rampling, T Ewer, K Bowyer, G Bliss, C Edwards, N Wright, D Payne, R Venkatraman, N Snudden, C Poulton, I Roberts, R Sinden, R Gerry, S Lawrie, A Gilbert, S Hill, A Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP |
| title | Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP |
| title_full | Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP |
| title_fullStr | Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP |
| title_full_unstemmed | Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP |
| title_short | Safety and high level efficacy of the combination malaria vaccine regimen of RTS,S/AS01B with ChAd-MVA vectored vaccines expressing ME-TRAP |
| title_sort | safety and high level efficacy of the combination malaria vaccine regimen of rts s as01b with chad mva vectored vaccines expressing me trap |
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