Data for: A Phase 1b, open-label, age de-escalation, dose-escalation study to evaluate the safety and immunogenicity of different doses of a candidate malaria vaccine; adjuvanted R21(R21/MM) in adults, young children and infants in Kilifi, Kenya

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Sang, Samuel; Datoo, Mehreen; Otieno, Edward; Muiruri, Charles; Gathuri, Emmaloise; Ngoto,Omar; Musembi, Janet; Bellamy, Duncan; Provstgaard-Morys, Samuel; Stockdale, Lisa; Aboagye, Jeremy; Woods, Daniel; Lawrie, Alison; Roberts, Rachel; Keter, Kelvias; Kimani, Domtila; Ndungu, Francis; Kapulu, Melissa; Njau, Irene; Orindi, Benedict; Ewer, Katie; Hill, Adrian V. S.; Bejon, Philip; Hamaluba, Mainga, 2023, "Data for: A Phase 1b, open-label, age de-escalation, dose-escalation study to evaluate the safety and immunogenicity of different doses of a candidate malaria vaccine; adjuvanted R21(R21/MM) in adults, young children and infants in Kilifi, Kenya", https://doi.org/10.7910/DVN/IRGZ35, Harvard Dataverse, V5, UNF:6:8VbuHGi8Xr05EETTLqzF9g== [fileUNF]

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Description	In the era of anti-malaria drug resistance and resistance to insecticide treated bed nets, there is an urgent need for a highly efficacious vaccine. We evaluated a candidate malaria vaccine incorporating the antigen R21 (part of the P. falciparum circumsporozoite malaria antigen co-expressed with hepatitis B antigen plus an adjuvant to boost the immune responses (Matrix-M). R21c/Matrix-M showed promising safety and immunogenicity data in preclinical and early phase trials in Oxford. We conducted an open label, age de-escalation, dose escalation study in 20 healthy adults (18-45 years), 20 young children aged 1-5 years and 51 infants aged 5- <12 months. Each participant was screened to ensure they were in good health based on clinical assessment and laboratory results. Participants had a blood test to ensure suitability prior to vaccination. For each participant, there was a total of 31 visits to the clinic and at home, 15 of which were associated with blood sampling (38 visits for those in the booster phase). Participants recieved 3 vaccinations 4 weeks apart. Blood tests and clinical assessments were conducted to screen out participants with health conditions that may have impacted participants or study outcomes. Bloods were taken at screening and a day prior to enrolment. Blood were also taken prior to each vaccination and on days 2 and 7 post vaccination at the clinic for the primary series ( 3 doses). Home visits were conducted on days 1, 3, 4, 5, and 6 to identify solicited adverse events. Bloods for immunology were taken prior to vaccination, and throughout the study to assess the immune response to R21/Matrix-M. In addition, we invited participants to receive a booster vaccine at 9-25 months after receipt of the 3rd vaccine of R21/Matrix-M and took bloods in clinic 28 days after boosting with field workers supporting participants or their parents/guardians to do this over the phone. During the booster vaccination visit (4th dose_, the participants/Parents/guardians were guided through the measurement of body temperature, assessment of the vaccination site (for redness, swelling and erythema) and documentation of the results on the diary card. They were then issued with a thermometer, vaccination ruler, a copy of the diary card and a pen to facilitate the completion of the remote safety assessments.
Subject	Medicine, Health and Life Sciences
Keyword	R21, Matrix-M™, Adults, children, infants, Kenya, falciparum, age de-escalation, dose escalation, safety, immunogenicity, CSP
License/Data Use Agreement	CC BY 4.0

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	childaes_anon.tab Tabular Data - 607.6 KB Published Jul 25, 2023 2 Downloads 26 Variables, 2208 Observations UNF:6:/CiyIZa9zxcIZb+d7qjM/A== Children and Infants Solicited Adverse events(local+systemic). Datacsv	Access File File Access Restricted Request Access Download Metadata Data File Citation Download EndNote XML Download RIS Download BibTeX
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	immunologydata.tab Tabular Data - 34.3 KB Published Jul 25, 2023 2 Downloads 5 Variables, 981 Observations UNF:6:BF467KZ6CTpbOps+CnX7pQ== Immunology data at all immunological study timepoints. Datacsv	Access File File Access Restricted Request Access Download Metadata Data File Citation Download EndNote XML Download RIS Download BibTeX
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Citation Metadata

Persistent Identifier	doi:10.7910/DVN/IRGZ35
Publication Date	2023-07-25
Title	Data for: A Phase 1b, open-label, age de-escalation, dose-escalation study to evaluate the safety and immunogenicity of different doses of a candidate malaria vaccine; adjuvanted R21(R21/MM) in adults, young children and infants in Kilifi, Kenya
Author	Sang, SamuelKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Datoo, MehreenCentre for Clinical Vaccinology and Tropical Medicine (CCVTM), The Jenner Institute, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, OX3 7LA, UK Otieno, EdwardKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Muiruri, CharlesKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Gathuri, EmmaloiseKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Ngoto,OmarKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Musembi, JanetKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Bellamy, DuncanThe Jenner Institute Laboratories, University of Oxford, UK Provstgaard-Morys, SamuelCentre for Clinical Vaccinology and Tropical Medicine (CCVTM), The Jenner Institute, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, OX3 7LA, UK Stockdale, LisaThe Jenner Institute Laboratories, University of Oxford, UK Aboagye, JeremyThe Jenner Institute Laboratories, University of Oxford, UK Woods, DanielThe Jenner Institute Laboratories, University of Oxford, UK Lawrie, AlisonCentre for Clinical Vaccinology and Tropical Medicine (CCVTM), The Jenner Institute, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, OX3 7LA, UK Roberts, RachelCentre for Clinical Vaccinology and Tropical Medicine (CCVTM), The Jenner Institute, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, OX3 7LA, UK Keter, KelviasKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Kimani, DomtilaKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Ndungu, FrancisKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Kapulu, MelissaKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Njau, IreneKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Orindi, BenedictKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Ewer, KatieThe Jenner Institute Laboratories, University of Oxford, UK Hill, Adrian V. S.Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), The Jenner Institute, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, OX3 7LA, UK Bejon, PhilipKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Hamaluba, MaingaKEMRI-Wellcome Trust Research Programme, Kilifi, Kenya
Point of Contact	Use email button above to contact. Hamaluba, Mainga (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) The Data Governance Committee (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)
Description	In the era of anti-malaria drug resistance and resistance to insecticide treated bed nets, there is an urgent need for a highly efficacious vaccine. We evaluated a candidate malaria vaccine incorporating the antigen R21 (part of the P. falciparum circumsporozoite malaria antigen co-expressed with hepatitis B antigen plus an adjuvant to boost the immune responses (Matrix-M). R21c/Matrix-M showed promising safety and immunogenicity data in preclinical and early phase trials in Oxford. We conducted an open label, age de-escalation, dose escalation study in 20 healthy adults (18-45 years), 20 young children aged 1-5 years and 51 infants aged 5- <12 months. Each participant was screened to ensure they were in good health based on clinical assessment and laboratory results. Participants had a blood test to ensure suitability prior to vaccination. For each participant, there was a total of 31 visits to the clinic and at home, 15 of which were associated with blood sampling (38 visits for those in the booster phase). Participants recieved 3 vaccinations 4 weeks apart. Blood tests and clinical assessments were conducted to screen out participants with health conditions that may have impacted participants or study outcomes. Bloods were taken at screening and a day prior to enrolment. Blood were also taken prior to each vaccination and on days 2 and 7 post vaccination at the clinic for the primary series ( 3 doses). Home visits were conducted on days 1, 3, 4, 5, and 6 to identify solicited adverse events. Bloods for immunology were taken prior to vaccination, and throughout the study to assess the immune response to R21/Matrix-M. In addition, we invited participants to receive a booster vaccine at 9-25 months after receipt of the 3rd vaccine of R21/Matrix-M and took bloods in clinic 28 days after boosting with field workers supporting participants or their parents/guardians to do this over the phone. During the booster vaccination visit (4th dose_, the participants/Parents/guardians were guided through the measurement of body temperature, assessment of the vaccination site (for redness, swelling and erythema) and documentation of the results on the diary card. They were then issued with a thermometer, vaccination ruler, a copy of the diary card and a pen to facilitate the completion of the remote safety assessments.
Subject	Medicine, Health and Life Sciences
Keyword	R21 Matrix-M™ Adults children infants Kenya falciparum age de-escalation dose escalation safety immunogenicity CSP
Depositor	Hamaluba, Mainga
Deposit Date	2023-07-24
Data Type	Clinical Trial

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