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Superior antibody immunogenicity of a viral-vectored RH5 blood-stage malaria vaccine in Tanzanian infants as compared to adults.
Silk, Sarah E; Kalinga, Wilmina F; Mtaka, Ivanny M; Lilolime, Nasoro S; Mpina, Maximillian; Milando, Florence; Ahmed, Saumu; Diouf, Ababacar; Mkwepu, Fatuma; Simon, Beatus; Athumani, Thabit; Rashid, Mohammed; Mohammed, Latipha; Lweno, Omary; Ali, Ali M; Nyaulingo, Gloria; Mwalimu, Bakari; Mswata, Sarah; Mwamlima, Tunu G; Barrett, Jordan R; Wang, Lawrence T; Themistocleous, Yrene; King, Lloyd D W; Hodgson, Susanne H; Payne, Ruth O; Nielsen, Carolyn M; Lawrie, Alison M; Nugent, Fay L; Cho, Jee-Sun; Long, Carole A; Miura, Kazutoyo; Draper, Simon J; Minassian, Angela M; Olotu, Ally I.
Afiliação
  • Silk SE; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Kalinga WF; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Mtaka IM; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Lilolime NS; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Mpina M; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Milando F; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Ahmed S; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Diouf A; Laboratory of Malaria and Vector Research, NIAID/NIH, Rockville, MD 20852, USA.
  • Mkwepu F; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Simon B; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Athumani T; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Rashid M; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Mohammed L; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Lweno O; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Ali AM; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Nyaulingo G; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Mwalimu B; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Mswata S; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Mwamlima TG; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
  • Barrett JR; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Wang LT; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Kavli Institute for Nanoscience Discovery, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK.
  • Themistocleous Y; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK.
  • King LDW; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Hodgson SH; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Payne RO; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK.
  • Nielsen CM; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Lawrie AM; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK.
  • Nugent FL; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK.
  • Cho JS; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Long CA; Laboratory of Malaria and Vector Research, NIAID/NIH, Rockville, MD 20852, USA.
  • Miura K; Laboratory of Malaria and Vector Research, NIAID/NIH, Rockville, MD 20852, USA.
  • Draper SJ; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Minassian AM; Department of Biochemistry, University of Oxford, Dorothy Crowfoot Hodgkin Building, Oxford OX1 3QU, UK; Centre for Clinical Vaccinology and Tropical Medicine, Jenner Institute, University of Oxford, Old Road Campus, Oxford OX3 7LE, UK; Kavli Institute for Nanoscience Discovery, University of Oxford
  • Olotu AI; Interventions and Clinical Trials Department, Ifakara Health Institute, P.O. Box 74, Bagamoyo, Tanzania.
Med ; 4(10): 668-686.e7, 2023 Oct 13.
Article em En | MEDLINE | ID: mdl-37572659
ABSTRACT

BACKGROUND:

RH5 is a leading blood-stage candidate antigen for a Plasmodium falciparum vaccine; however, its safety and immunogenicity in malaria-endemic populations are unknown.

METHODS:

A phase 1b, single-center, dose-escalation, age-de-escalation, double-blind, randomized, controlled trial was conducted in Bagamoyo, Tanzania (NCT03435874). Between 12th April and 25th October 2018, 63 healthy adults (18-35 years), young children (1-6 years), and infants (6-11 months) received a priming dose of viral-vectored ChAd63 RH5 or rabies control vaccine. Sixty participants were boosted with modified vaccinia virus Ankara (MVA) RH5 or rabies control vaccine 8 weeks later and completed 6 months of follow-up post priming. Primary outcomes were the number of solicited and unsolicited adverse events post vaccination and the number of serious adverse events over the study period. Secondary outcomes included measures of the anti-RH5 immune response.

FINDINGS:

Vaccinations were well tolerated, with profiles comparable across groups. No serious adverse events were reported. Vaccination induced RH5-specific cellular and humoral responses. Higher anti-RH5 serum immunoglobulin G (IgG) responses were observed post boost in young children and infants compared to adults. Vaccine-induced antibodies showed growth inhibition activity (GIA) in vitro against P. falciparum blood-stage parasites; their highest levels were observed in infants.

CONCLUSIONS:

The ChAd63-MVA RH5 vaccine shows acceptable safety and reactogenicity and encouraging immunogenicity in children and infants residing in a malaria-endemic area. The levels of functional GIA observed in RH5-vaccinated infants are the highest reported to date following human vaccination. These data support onward clinical development of RH5-based blood-stage vaccines to protect against clinical malaria in young African infants.

FUNDING:

Medical Research Council, London, UK.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 1_ASSA2030 / 2_ODS3 / 3_ND Problema de saúde: 1_doencas_transmissiveis / 2_enfermedades_transmissibles / 3_malaria / 3_neglected_diseases / 3_zoonosis Assunto principal: Malária Falciparum / Vacinas Antimaláricas Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Child / Child, preschool / Humans / Infant País/Região como assunto: Africa Idioma: En Revista: Med Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Adicionar na Minha BVS
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 1_ASSA2030 / 2_ODS3 / 3_ND Problema de saúde: 1_doencas_transmissiveis / 2_enfermedades_transmissibles / 3_malaria / 3_neglected_diseases / 3_zoonosis Assunto principal: Malária Falciparum / Vacinas Antimaláricas Tipo de estudo: Clinical_trials Limite: Adolescent / Adult / Child / Child, preschool / Humans / Infant País/Região como assunto: Africa Idioma: En Revista: Med Ano de publicação: 2023 Tipo de documento: Article