Booster Vaccine for Yellow Fever

Summary

This is a phase III trial on Children. The investigators will enroll a total of 750 participants in Fajikunda Health Center (Gambia) The aims of the study are * To describe the safety and immunogenicity of a booster dose of a licensed yellow fever vaccine administered to 3 different age cohorts of children, following a documented primary dose of a yellow fever vaccine administered at nine-months of age. * To characterise the rate of yellow-fever PRNT sero-reversion (seropositive to seronegative) over a period of 9 months to 8 years following a single primary dose of yellow fever vaccine administered to Gambian infants at nine months age. * To profile the immune response to the booster dose of YF vaccine in order to explore underlying mechanisms for longevity of vaccine-induced antibody.

Timeline

Start

2022-05-16

Primary completion

2023-06

Completion

2023-09

Publications

• Background Rezende IM, Sacchetto L, Munhoz de Mello E, Alves PA, Iani FCM, Adelino TER, Duarte MM, Cury ALF, Bernardes AFL, Santos TA, Pereira LS, Dutra MRT, Ramalho DB, de Thoisy B, Kroon EG, Trindade GS, Drumond BP. Persistence of Yellow fever virus outside the Amazon Basin, causing epidemics in Southeast Brazil, from 2016 to 2018. PLoS Negl Trop Dis. 2018 Jun 4;12(6):e0006538. doi: 10.1371/journal.pntd.0006538. eCollection 2018 Jun.
• Background Domingo C, Fraissinet J, Ansah PO, Kelly C, Bhat N, Sow SO, Mejia JE. Long-term immunity against yellow fever in children vaccinated during infancy: a longitudinal cohort study. Lancet Infect Dis. 2019 Dec;19(12):1363-1370. doi: 10.1016/S1473-3099(19)30323-8. Epub 2019 Sep 19.
• Background Idoko OT, Domingo C, Tapia MD, Sow SO, Geldmacher C, Saathoff E, Kampmann B. Serological Protection 5-6 Years Post Vaccination Against Yellow Fever in African Infants Vaccinated in Routine Programmes. Front Immunol. 2020 Oct 8;11:577751. doi: 10.3389/fimmu.2020.577751. eCollection 2020.
• Background Campi-Azevedo AC, Reis LR, Peruhype-Magalhaes V, Coelho-Dos-Reis JG, Antonelli LR, Fonseca CT, Costa-Pereira C, Souza-Fagundes EM, da Costa-Rocha IA, Mambrini JVM, Lemos JAC, Ribeiro JGL, Caldas IR, Camacho LAB, Maia MLS, de Noronha TG, de Lima SMB, Simoes M, Freire MDS, Martins RM, Homma A, Tauil PL, Vasconcelos PFC, Romano APM, Domingues CM, Teixeira-Carvalho A, Martins-Filho OA. Short-Lived Immunity After 17DD Yellow Fever Single Dose Indicates That Booster Vaccination May Be Required to Guarantee Protective Immunity in Children. Front Immunol. 2019 Sep 26;10:2192. doi: 10.3389/fimmu.2019.02192. eCollection 2019.
• Background de Noronha TG, de Lourdes de Sousa Maia M, Geraldo Leite Ribeiro J, Campos Lemos JA, Maria Barbosa de Lima S, Martins-Filho OA, Campi-Azevedo AC, da Silva Freire M, de Menezes Martins R, Bastos Camacho LA; Collaborative Group for Studies of Yellow Fever Vaccine. Duration of post-vaccination humoral immunity against yellow fever in children. Vaccine. 2019 Nov 15;37(48):7147-7154. doi: 10.1016/j.vaccine.2019.09.051. Epub 2019 Oct 4.
• Background Vaccines and vaccination against yellow fever. WHO position paper -- June 2013. Wkly Epidemiol Rec. 2013 Jul 5;88(27):269-83. No abstract available. English, French.
• Background Staples JE, Barrett ADT, Wilder-Smith A, Hombach J. Review of data and knowledge gaps regarding yellow fever vaccine-induced immunity and duration of protection. NPJ Vaccines. 2020 Jul 6;5(1):54. doi: 10.1038/s41541-020-0205-6. eCollection 2020.
• Background Grobusch MP, Goorhuis A, Wieten RW, Verberk JD, Jonker EF, van Genderen PJ, Visser LG. Yellow fever revaccination guidelines change - a decision too feverish? Clin Microbiol Infect. 2013 Oct;19(10):885-6. doi: 10.1111/1469-0691.12332. Epub 2013 Aug 8. No abstract available.
• Background Bovay A, Nassiri S, Maby-El Hajjami H, Marcos Mondejar P, Akondy RS, Ahmed R, Lawson B, Speiser DE, Fuertes Marraco SA. Minimal immune response to booster vaccination against Yellow Fever associated with pre-existing antibodies. Vaccine. 2020 Feb 24;38(9):2172-2182. doi: 10.1016/j.vaccine.2020.01.045. Epub 2020 Jan 31.
• Background Kongsgaard M, Bassi MR, Rasmussen M, Skjodt K, Thybo S, Gabriel M, Hansen MB, Christensen JP, Thomsen AR, Buus S, Stryhn A. Adaptive immune responses to booster vaccination against yellow fever virus are much reduced compared to those after primary vaccination. Sci Rep. 2017 Apr 6;7(1):662. doi: 10.1038/s41598-017-00798-1.
• Background Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.
• Background Querec TD, Akondy RS, Lee EK, Cao W, Nakaya HI, Teuwen D, Pirani A, Gernert K, Deng J, Marzolf B, Kennedy K, Wu H, Bennouna S, Oluoch H, Miller J, Vencio RZ, Mulligan M, Aderem A, Ahmed R, Pulendran B. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol. 2009 Jan;10(1):116-125. doi: 10.1038/ni.1688. Epub 2008 Nov 23.
• Background Co MD, Terajima M, Cruz J, Ennis FA, Rothman AL. Human cytotoxic T lymphocyte responses to live attenuated 17D yellow fever vaccine: identification of HLA-B35-restricted CTL epitopes on nonstructural proteins NS1, NS2b, NS3, and the structural protein E. Virology. 2002 Feb 1;293(1):151-63. doi: 10.1006/viro.2001.1255.
• Pley C, Jeffries DJ, Kanteh E, Strandmark J, Baldeh AK, Leigh MN, Ndow P, Clarke E, Kampmann B. Yellow fever vaccination in healthy Gambian children of different ages to establish safety and immunogenicity of a booster dose: a open-label, non-randomised, single-site, phase 3 vaccine trial. Lancet Infect Dis. 2026 Jun 11:S1473-3099(26)00193-3. doi: 10.1016/S1473-3099(26)00193-3. Online ahead of print.
• Kampmann B, Pley C, Strandmark J, Leigh MN, Ndow P, Clarke E, Roberts E, Faal A, Jeffries D, Kanteh E. Booster Vaccination against Yellow Fever in Gambian children-(BoVY) -a Phase 3 clinical trial to establish safety and immunogenicity of repeated YF vaccination in healthy Gambian children of different ages. Wellcome Open Res. 2024 Dec 24;9:733. doi: 10.12688/wellcomeopenres.23138.1. eCollection 2024.

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