Nelli Westercamp, Lawrence Osei-Tutu, Lode Schuerman, Simon K Kariuki, Anne Bollaerts, Cynthia K Lee, Aaron M Samuels, Christian Ockenhouse, Dennis K Bii, Samuel Adjei, Martina Oneko, Marc Lievens, Maame Anima Attobrah Sarfo, Cecilia Atieno, Ashura Bakari, Tony Sang, Maame Fremah Kotoh-Mortty, Kephas Otieno, François Roman, Patrick Boakye Yiadom Buabeng, Yaw Ntiamoah, Daniel Ansong, Tsiri Agbenyega, Opokua Ofori-Anyinam
{"title":"能否少而精？在衡量 RTS、S/AS01E 疟疾疫苗的影响时，考虑部分剂量方案和不同的疫苗剂量。","authors":"Nelli Westercamp, Lawrence Osei-Tutu, Lode Schuerman, Simon K Kariuki, Anne Bollaerts, Cynthia K Lee, Aaron M Samuels, Christian Ockenhouse, Dennis K Bii, Samuel Adjei, Martina Oneko, Marc Lievens, Maame Anima Attobrah Sarfo, Cecilia Atieno, Ashura Bakari, Tony Sang, Maame Fremah Kotoh-Mortty, Kephas Otieno, François Roman, Patrick Boakye Yiadom Buabeng, Yaw Ntiamoah, Daniel Ansong, Tsiri Agbenyega, Opokua Ofori-Anyinam","doi":"10.1093/infdis/jiae075","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The RTS,S/AS01E (RTS,S) malaria vaccine is recommended for children in malaria endemic areas. This phase 2b trial evaluates RTS,S fractional- and full-dose regimens in Ghana and Kenya.</p><p><strong>Methods: </strong>In total, 1500 children aged 5-17 months were randomized (1:1:1:1:1) to receive RTS,S or rabies control vaccine. RTS,S groups received 2 full RTS,S doses at months 0 and 1 and either full (groups R012-20, R012-14-26) or fractional doses (one-fifth; groups Fx012-14-26, Fx017-20-32).</p><p><strong>Results: </strong>At month 32 post-dose 1, vaccine efficacy against clinical malaria (all episodes) ranged from 38% (R012-20; 95% confidence interval [CI]: 24%-49%) to 53% (R012-14-26; 95% CI: 42%-62%). Vaccine impact (cumulative number of cases averted/1000 children vaccinated) was 1344 (R012-20), 2450 (R012-14-26), 2273 (Fx012-14-26), and 2112 (Fx017-20-32). To account for differences in vaccine volume (fractional vs full dose; post hoc analysis), we estimated cases averted/1000 RTS,S full-dose equivalents: 336 (R012-20), 490 (R012-14-26), 874 (Fx012-14-26), and 880 (Fx017-20-32).</p><p><strong>Conclusions: </strong>Vaccine efficacy was similar across RTS,S groups. Vaccine impact accounting for full-dose equivalence suggests that using fractional-dose regimens could be a viable dose-sparing strategy. If maintained through trial end, these observations underscore the means to reduce cost per regimen thus maximizing impact and optimizing supply.</p><p><strong>Clinical trials registration: </strong>NCT03276962 (ClinicalTrials.gov).</p>","PeriodicalId":50179,"journal":{"name":"Journal of Infectious Diseases","volume":null,"pages":null},"PeriodicalIF":5.0000,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11326831/pdf/","citationCount":"0","resultStr":"{\"title\":\"Could Less Be More? 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This phase 2b trial evaluates RTS,S fractional- and full-dose regimens in Ghana and Kenya.</p><p><strong>Methods: </strong>In total, 1500 children aged 5-17 months were randomized (1:1:1:1:1) to receive RTS,S or rabies control vaccine. RTS,S groups received 2 full RTS,S doses at months 0 and 1 and either full (groups R012-20, R012-14-26) or fractional doses (one-fifth; groups Fx012-14-26, Fx017-20-32).</p><p><strong>Results: </strong>At month 32 post-dose 1, vaccine efficacy against clinical malaria (all episodes) ranged from 38% (R012-20; 95% confidence interval [CI]: 24%-49%) to 53% (R012-14-26; 95% CI: 42%-62%). Vaccine impact (cumulative number of cases averted/1000 children vaccinated) was 1344 (R012-20), 2450 (R012-14-26), 2273 (Fx012-14-26), and 2112 (Fx017-20-32). To account for differences in vaccine volume (fractional vs full dose; post hoc analysis), we estimated cases averted/1000 RTS,S full-dose equivalents: 336 (R012-20), 490 (R012-14-26), 874 (Fx012-14-26), and 880 (Fx017-20-32).</p><p><strong>Conclusions: </strong>Vaccine efficacy was similar across RTS,S groups. Vaccine impact accounting for full-dose equivalence suggests that using fractional-dose regimens could be a viable dose-sparing strategy. 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Could Less Be More? Accounting for Fractional-Dose Regimens and Different Number of Vaccine Doses When Measuring the Impact of the RTS,S/AS01E Malaria Vaccine.
Background: The RTS,S/AS01E (RTS,S) malaria vaccine is recommended for children in malaria endemic areas. This phase 2b trial evaluates RTS,S fractional- and full-dose regimens in Ghana and Kenya.
Methods: In total, 1500 children aged 5-17 months were randomized (1:1:1:1:1) to receive RTS,S or rabies control vaccine. RTS,S groups received 2 full RTS,S doses at months 0 and 1 and either full (groups R012-20, R012-14-26) or fractional doses (one-fifth; groups Fx012-14-26, Fx017-20-32).
Results: At month 32 post-dose 1, vaccine efficacy against clinical malaria (all episodes) ranged from 38% (R012-20; 95% confidence interval [CI]: 24%-49%) to 53% (R012-14-26; 95% CI: 42%-62%). Vaccine impact (cumulative number of cases averted/1000 children vaccinated) was 1344 (R012-20), 2450 (R012-14-26), 2273 (Fx012-14-26), and 2112 (Fx017-20-32). To account for differences in vaccine volume (fractional vs full dose; post hoc analysis), we estimated cases averted/1000 RTS,S full-dose equivalents: 336 (R012-20), 490 (R012-14-26), 874 (Fx012-14-26), and 880 (Fx017-20-32).
Conclusions: Vaccine efficacy was similar across RTS,S groups. Vaccine impact accounting for full-dose equivalence suggests that using fractional-dose regimens could be a viable dose-sparing strategy. If maintained through trial end, these observations underscore the means to reduce cost per regimen thus maximizing impact and optimizing supply.
期刊介绍：
Published continuously since 1904, The Journal of Infectious Diseases (JID) is the premier global journal for original research on infectious diseases. The editors welcome Major Articles and Brief Reports describing research results on microbiology, immunology, epidemiology, and related disciplines, on the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on disorders of host immune responses. JID is an official publication of the Infectious Diseases Society of America.
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