Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults

Caroline Ogwang; Muhammed Afolabi; Domtila Kimani; Ya Jankey Jagne; Susanne H. Sheehy; Carly M. Bliss; Christopher J.A. Duncan; Katharine A. Collins; Miguel A. Garcia Knight; Eva Kimani; Nicholas A. Anagnostou; Eleanor Berrie; Sarah Moyle; Sarah C. Gilbert; Alexandra J. Spencer; Peninah Soipei; Jenny Mueller; Joseph Okebe; Stefano Colloca; Riccardo Cortese; Nicola K. Viebig; Rachel Roberts; Katherine Gantlett; Alison M. Lawrie; Alfredo Nicosia; Egeruan B. Imoukhuede; Philip Bejon; Britta C. Urban; Katie L. Flanagan; Katie J. Ewer; Roma Chilengi; Adrian V.S. Hill; Kalifa Bojang

doi:10.1371/journal.pone.0057726

Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults

Caroline Ogwang, Muhammed Afolabi, Domtila Kimani, Ya Jankey Jagne, Susanne H. Sheehy, Carly M. Bliss, Christopher J.A. Duncan, Katharine A. Collins, Miguel A. Garcia Knight, Eva Kimani, Nicholas A. Anagnostou, Eleanor Berrie, Sarah Moyle, Sarah C. Gilbert, Alexandra J. Spencer, Peninah Soipei, Jenny Mueller, Joseph Okebe, Stefano Colloca, Riccardo CorteseNicola K. Viebig, Rachel Roberts, Katherine Gantlett, Alison M. Lawrie, Alfredo Nicosia, Egeruan B. Imoukhuede, Philip Bejon, Britta C. Urban, Katie L. Flanagan, Katie J. Ewer, Roma Chilengi, Adrian V.S. Hill, Kalifa Bojang

Research output: Contribution to journal › Article › peer-review

62 Scopus citations

Abstract

Background: Heterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified vaccinia Virus Ankara (MVA) vectored vaccines is a strategy recently shown to be capable of inducing strong cell mediated responses against several antigens from the malaria parasite. ChAd63-MVA expressing the Plasmodium falciparum pre-erythrocytic antigen ME-TRAP (multiple epitope string with thrombospondin-related adhesion protein) is a leading malaria vaccine candidate, capable of inducing sterile protection in malaria naïve adults following controlled human malaria infection (CHMI). Methodology: We conducted two Phase Ib dose escalation clinical trials assessing the safety and immunogenicity of ChAd63-MVA ME-TRAP in 46 healthy malaria exposed adults in two African countries with similar malaria transmission patterns. Results: ChAd63-MVA ME-TRAP was shown to be safe and immunogenic, inducing high-level T cell responses (median >1300 SFU/million PBMC). Conclusions: ChAd63-MVA ME-TRAP is a safe and highly immunogenic vaccine regimen in adults with prior exposure to malaria. Further clinical trials to assess safety and immunogenicity in children and infants and protective efficacy in the field are now warranted. Trial Registration: Pactr.org PACTR2010020001771828 Pactr.org PACTR201008000221638 ClinicalTrials.gov NCT01373879 ClinicalTrials.gov NCT01379430.

Original language	English
Article number	e57726
Journal	PLoS ONE
Volume	8
Issue number	3
DOIs	https://doi.org/10.1371/journal.pone.0057726
State	Published - 19 Mar 2013
Externally published	Yes

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Ogwang, C., Afolabi, M., Kimani, D., Jagne, Y. J., Sheehy, S. H., Bliss, C. M., Duncan, C. J. A., Collins, K. A., Garcia Knight, M. A., Kimani, E., Anagnostou, N. A., Berrie, E., Moyle, S., Gilbert, S. C., Spencer, A. J., Soipei, P., Mueller, J., Okebe, J., Colloca, S., ... Bojang, K. (2013). Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults. PLoS ONE, 8(3), Article e57726. https://doi.org/10.1371/journal.pone.0057726

@article{1646f7c92f8e4379baf82d35871f5b2f,

title = "Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults",

abstract = "Background: Heterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified vaccinia Virus Ankara (MVA) vectored vaccines is a strategy recently shown to be capable of inducing strong cell mediated responses against several antigens from the malaria parasite. ChAd63-MVA expressing the Plasmodium falciparum pre-erythrocytic antigen ME-TRAP (multiple epitope string with thrombospondin-related adhesion protein) is a leading malaria vaccine candidate, capable of inducing sterile protection in malaria na{\"i}ve adults following controlled human malaria infection (CHMI). Methodology: We conducted two Phase Ib dose escalation clinical trials assessing the safety and immunogenicity of ChAd63-MVA ME-TRAP in 46 healthy malaria exposed adults in two African countries with similar malaria transmission patterns. Results: ChAd63-MVA ME-TRAP was shown to be safe and immunogenic, inducing high-level T cell responses (median >1300 SFU/million PBMC). Conclusions: ChAd63-MVA ME-TRAP is a safe and highly immunogenic vaccine regimen in adults with prior exposure to malaria. Further clinical trials to assess safety and immunogenicity in children and infants and protective efficacy in the field are now warranted. Trial Registration: Pactr.org PACTR2010020001771828 Pactr.org PACTR201008000221638 ClinicalTrials.gov NCT01373879 ClinicalTrials.gov NCT01379430.",

author = "Caroline Ogwang and Muhammed Afolabi and Domtila Kimani and Jagne, {Ya Jankey} and Sheehy, {Susanne H.} and Bliss, {Carly M.} and Duncan, {Christopher J.A.} and Collins, {Katharine A.} and {Garcia Knight}, {Miguel A.} and Eva Kimani and Anagnostou, {Nicholas A.} and Eleanor Berrie and Sarah Moyle and Gilbert, {Sarah C.} and Spencer, {Alexandra J.} and Peninah Soipei and Jenny Mueller and Joseph Okebe and Stefano Colloca and Riccardo Cortese and Viebig, {Nicola K.} and Rachel Roberts and Katherine Gantlett and Lawrie, {Alison M.} and Alfredo Nicosia and Imoukhuede, {Egeruan B.} and Philip Bejon and Urban, {Britta C.} and Flanagan, {Katie L.} and Ewer, {Katie J.} and Roma Chilengi and Hill, {Adrian V.S.} and Kalifa Bojang",

year = "2013",

month = mar,

day = "19",

doi = "10.1371/journal.pone.0057726",

language = "English",

volume = "8",

journal = "PLoS ONE",

issn = "1932-6203",

publisher = "Public Library of Science",

number = "3",

}

Ogwang, C, Afolabi, M, Kimani, D, Jagne, YJ, Sheehy, SH, Bliss, CM, Duncan, CJA, Collins, KA, Garcia Knight, MA, Kimani, E, Anagnostou, NA, Berrie, E, Moyle, S, Gilbert, SC, Spencer, AJ, Soipei, P, Mueller, J, Okebe, J, Colloca, S, Cortese, R, Viebig, NK, Roberts, R, Gantlett, K, Lawrie, AM, Nicosia, A, Imoukhuede, EB, Bejon, P, Urban, BC, Flanagan, KL, Ewer, KJ, Chilengi, R, Hill, AVS & Bojang, K 2013, 'Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults', PLoS ONE, vol. 8, no. 3, e57726. https://doi.org/10.1371/journal.pone.0057726

Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults. / Ogwang, Caroline; Afolabi, Muhammed; Kimani, Domtila et al.
In: PLoS ONE, Vol. 8, No. 3, e57726, 19.03.2013.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults

AU - Ogwang, Caroline

AU - Afolabi, Muhammed

AU - Kimani, Domtila

AU - Jagne, Ya Jankey

AU - Sheehy, Susanne H.

AU - Bliss, Carly M.

AU - Duncan, Christopher J.A.

AU - Collins, Katharine A.

AU - Garcia Knight, Miguel A.

AU - Kimani, Eva

AU - Anagnostou, Nicholas A.

AU - Berrie, Eleanor

AU - Moyle, Sarah

AU - Gilbert, Sarah C.

AU - Spencer, Alexandra J.

AU - Soipei, Peninah

AU - Mueller, Jenny

AU - Okebe, Joseph

AU - Colloca, Stefano

AU - Cortese, Riccardo

AU - Viebig, Nicola K.

AU - Roberts, Rachel

AU - Gantlett, Katherine

AU - Lawrie, Alison M.

AU - Nicosia, Alfredo

AU - Imoukhuede, Egeruan B.

AU - Bejon, Philip

AU - Urban, Britta C.

AU - Flanagan, Katie L.

AU - Ewer, Katie J.

AU - Chilengi, Roma

AU - Hill, Adrian V.S.

AU - Bojang, Kalifa

PY - 2013/3/19

Y1 - 2013/3/19

N2 - Background: Heterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified vaccinia Virus Ankara (MVA) vectored vaccines is a strategy recently shown to be capable of inducing strong cell mediated responses against several antigens from the malaria parasite. ChAd63-MVA expressing the Plasmodium falciparum pre-erythrocytic antigen ME-TRAP (multiple epitope string with thrombospondin-related adhesion protein) is a leading malaria vaccine candidate, capable of inducing sterile protection in malaria naïve adults following controlled human malaria infection (CHMI). Methodology: We conducted two Phase Ib dose escalation clinical trials assessing the safety and immunogenicity of ChAd63-MVA ME-TRAP in 46 healthy malaria exposed adults in two African countries with similar malaria transmission patterns. Results: ChAd63-MVA ME-TRAP was shown to be safe and immunogenic, inducing high-level T cell responses (median >1300 SFU/million PBMC). Conclusions: ChAd63-MVA ME-TRAP is a safe and highly immunogenic vaccine regimen in adults with prior exposure to malaria. Further clinical trials to assess safety and immunogenicity in children and infants and protective efficacy in the field are now warranted. Trial Registration: Pactr.org PACTR2010020001771828 Pactr.org PACTR201008000221638 ClinicalTrials.gov NCT01373879 ClinicalTrials.gov NCT01379430.

AB - Background: Heterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified vaccinia Virus Ankara (MVA) vectored vaccines is a strategy recently shown to be capable of inducing strong cell mediated responses against several antigens from the malaria parasite. ChAd63-MVA expressing the Plasmodium falciparum pre-erythrocytic antigen ME-TRAP (multiple epitope string with thrombospondin-related adhesion protein) is a leading malaria vaccine candidate, capable of inducing sterile protection in malaria naïve adults following controlled human malaria infection (CHMI). Methodology: We conducted two Phase Ib dose escalation clinical trials assessing the safety and immunogenicity of ChAd63-MVA ME-TRAP in 46 healthy malaria exposed adults in two African countries with similar malaria transmission patterns. Results: ChAd63-MVA ME-TRAP was shown to be safe and immunogenic, inducing high-level T cell responses (median >1300 SFU/million PBMC). Conclusions: ChAd63-MVA ME-TRAP is a safe and highly immunogenic vaccine regimen in adults with prior exposure to malaria. Further clinical trials to assess safety and immunogenicity in children and infants and protective efficacy in the field are now warranted. Trial Registration: Pactr.org PACTR2010020001771828 Pactr.org PACTR201008000221638 ClinicalTrials.gov NCT01373879 ClinicalTrials.gov NCT01379430.

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U2 - 10.1371/journal.pone.0057726

DO - 10.1371/journal.pone.0057726

M3 - Article

C2 - 23526949

AN - SCOPUS:84875111833

SN - 1932-6203

VL - 8

JO - PLoS ONE

JF - PLoS ONE

IS - 3

M1 - e57726

ER -

Safety and Immunogenicity of Heterologous Prime-Boost Immunisation with Plasmodium falciparum Malaria Candidate Vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in Healthy Gambian and Kenyan Adults

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