A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.
BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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2012
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| _version_ | 1826285153717059584 |
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| author | Agnandji, S Lell, B Fernandes, J Abossolo, B Methogo, BG Kabwende, A Adegnika, A Mordmüller, B Issifou, S Kremsner, P Sacarlal, J Aide, P Lanaspa, M Aponte, J Machevo, S Acacio, S Bulo, H Sigauque, B Macete, E Alonso, P Abdulla, S Salim, N Minja, R Mpina, M Ahmed, S |
| author_facet | Agnandji, S Lell, B Fernandes, J Abossolo, B Methogo, BG Kabwende, A Adegnika, A Mordmüller, B Issifou, S Kremsner, P Sacarlal, J Aide, P Lanaspa, M Aponte, J Machevo, S Acacio, S Bulo, H Sigauque, B Macete, E Alonso, P Abdulla, S Salim, N Minja, R Mpina, M Ahmed, S |
| author_sort | Agnandji, S |
| collection | OXFORD |
| description | BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed. RESULTS: The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.). |
| first_indexed | 2024-03-07T01:24:35Z |
| format | Journal article |
| id | oxford-uuid:91882ef5-c5cc-4b7c-bf09-935007464502 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T01:24:35Z |
| publishDate | 2012 |
| record_format | dspace |
| spelling | oxford-uuid:91882ef5-c5cc-4b7c-bf09-9350074645022022-03-26T23:19:23ZA phase 3 trial of RTS,S/AS01 malaria vaccine in African infants.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:91882ef5-c5cc-4b7c-bf09-935007464502EnglishSymplectic Elements at Oxford2012Agnandji, SLell, BFernandes, JAbossolo, BMethogo, BGKabwende, AAdegnika, AMordmüller, BIssifou, SKremsner, PSacarlal, JAide, PLanaspa, MAponte, JMachevo, SAcacio, SBulo, HSigauque, BMacete, EAlonso, PAbdulla, SSalim, NMinja, RMpina, MAhmed, SBACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed. RESULTS: The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.). |
| spellingShingle | Agnandji, S Lell, B Fernandes, J Abossolo, B Methogo, BG Kabwende, A Adegnika, A Mordmüller, B Issifou, S Kremsner, P Sacarlal, J Aide, P Lanaspa, M Aponte, J Machevo, S Acacio, S Bulo, H Sigauque, B Macete, E Alonso, P Abdulla, S Salim, N Minja, R Mpina, M Ahmed, S A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. |
| title | A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. |
| title_full | A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. |
| title_fullStr | A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. |
| title_full_unstemmed | A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. |
| title_short | A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. |
| title_sort | phase 3 trial of rts s as01 malaria vaccine in african infants |
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