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• W4366596212 abstract "Abstract Background RH5 is the leading blood-stage candidate antigen for inclusion in a Plasmodium falciparum malaria vaccine, however, its safety profile and ability to induce functional immune responses in a malaria-endemic population are unknown. Characterising safety and immunogenicity is key to refine and progress next-generation RH5-based blood-stage malaria vaccines to field efficacy assessment. Methods A Phase 1b, single-center, dose-escalation, age de-escalation, double-blind, randomized, controlled trial was conducted in Bagamoyo, Tanzania. Healthy adults (18-35 years), young children (1-6 years) and infants (6-11 months) were recruited to receive a priming dose of viral-vectored ChAd63 RH5 (or rabies control vaccine) followed by a booster dose of MVA RH5 (or rabies control vaccine) 8 weeks later. The primary outcomes were the number of solicited and unsolicited adverse events following vaccination and the number of serious adverse events over the whole study period. Secondary outcomes included quantitative and qualitative measures of the anti-RH5 immune response. All participants receiving at least one dose of vaccine were included in the primary analyses. Findings Between 12 th April and 25 th October 2018 a total of 63 adults, children and infants were recruited and primed and 60 of these were boosted, all completing six months of follow-up post-priming vaccination. Vaccinations were well-tolerated with participants reporting predominantly mild reactogenicity, with profiles comparable between ChAd63 RH5, MVA RH5 and rabies vaccine groups, and across the age groups. No serious adverse events were reported during the study period. RH5-specific T cell, B cell and serum antibody responses were induced by vaccination. Higher anti-RH5 serum IgG responses were observed post-boost in the 1-6 year old children (median 93 µg/mL; range: 31-508 µg/mL) and infants (median 149 µg/mL; range: 29-352 µg/mL) as compared to adults (median 14 µg/mL; range: 9-15 µg/mL). These contracted over time post-boost, but the same hierarchy of responses across the age groups was maintained to end of follow-up at 16 weeks post-boost (day 168). Vaccine-induced anti-RH5 antibodies were functional showing growth inhibition activity (GIA) in vitro against P. falciparum blood-stage parasites. The highest levels were observed in the 6-11 month old infants, with 6/11 showing >60% GIA following dilution of total IgG to 2.5 mg/mL (median 61%; range: 41-78%). Interpretation The ChAd63-MVA RH5 vaccine regimen shows an acceptable safety and reactogenicity profile and encouraging immunogenicity in children and infants residing in a malaria-endemic area. The levels of functional GIA observed in the RH5 vaccinated 6-11 month old infants are the highest levels reported to-date following human vaccination. These data support onward clinical development of RH5-based blood-stage vaccines that aim to protect against clinical malaria in young African infants. Funding Medical Research Council, London, United Kingdom. Trial Registration ISRCTN registry: 47448832 and ClinicalTrials.gov: NCT03435874 ." @default.
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• W4366596212 date "2023-04-20" @default.
• W4366596212 modified "2023-09-27" @default.
• W4366596212 title "Superior antibody immunogenicity of a RH5 blood-stage malaria vaccine in Tanzanian infants as compared to adults" @default.
• W4366596212 cites W1967869186 @default.
• W4366596212 cites W1969689914 @default.
• W4366596212 cites W1971747284 @default.
• W4366596212 cites W1973228533 @default.
• W4366596212 cites W1986157072 @default.
• W4366596212 cites W1986169276 @default.
• W4366596212 cites W1987907586 @default.
• W4366596212 cites W1991572419 @default.
• W4366596212 cites W1992532969 @default.
• W4366596212 cites W1996313125 @default.
• W4366596212 cites W2002833434 @default.
• W4366596212 cites W2010146342 @default.
• W4366596212 cites W2012717122 @default.
• W4366596212 cites W2021540724 @default.
• W4366596212 cites W2028362346 @default.
• W4366596212 cites W2030388818 @default.
• W4366596212 cites W2033299041 @default.
• W4366596212 cites W2034926863 @default.
• W4366596212 cites W2039735909 @default.
• W4366596212 cites W2053384778 @default.
• W4366596212 cites W2054347139 @default.
• W4366596212 cites W2055398899 @default.
• W4366596212 cites W2065417495 @default.
• W4366596212 cites W2090211342 @default.
• W4366596212 cites W2126082637 @default.
• W4366596212 cites W2129316783 @default.
• W4366596212 cites W2130629422 @default.
• W4366596212 cites W2147803077 @default.
• W4366596212 cites W2165066248 @default.
• W4366596212 cites W2270629588 @default.
• W4366596212 cites W2314625902 @default.
• W4366596212 cites W2343475147 @default.
• W4366596212 cites W2492777583 @default.
• W4366596212 cites W2561522913 @default.
• W4366596212 cites W2577477566 @default.
• W4366596212 cites W2626760342 @default.
• W4366596212 cites W2765332961 @default.
• W4366596212 cites W2791950689 @default.
• W4366596212 cites W2810551456 @default.
• W4366596212 cites W2825109425 @default.
• W4366596212 cites W2941988565 @default.
• W4366596212 cites W2980333031 @default.
• W4366596212 cites W2981221108 @default.
• W4366596212 cites W2983844272 @default.
• W4366596212 cites W3022853859 @default.
• W4366596212 cites W3026498324 @default.
• W4366596212 cites W3111128314 @default.
• W4366596212 cites W3112115390 @default.
• W4366596212 cites W3123726719 @default.
• W4366596212 cites W3128936389 @default.
• W4366596212 cites W3140226555 @default.
• W4366596212 cites W3156568793 @default.
• W4366596212 cites W3158165973 @default.
• W4366596212 cites W3177637593 @default.
• W4366596212 cites W4200290759 @default.
• W4366596212 cites W4254848468 @default.
• W4366596212 cites W4281664746 @default.
• W4366596212 cites W4288058399 @default.
• W4366596212 cites W4309513060 @default.
• W4366596212 cites W4317761608 @default.
• W4366596212 cites W65828984 @default.

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