A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

Issaka Sagara; Alassane Dicko; Ruth D. Ellis; Michael P. Fay; Sory I. Diawara; Mahamadoun H. Assadou; Mahamadou S. Sissoko; Mamady Kone; Abdoulbaki I. Diallo; Renion Saye; Merepen A. Guindo; Ousmane Kante; Mohamed B. Niambele; Kazutoyo Miura; Gregory E. D. Mullen; Mark Pierce; Laura B. Martin; Amagana Dolo; Dapa A. Diallo; Ogobara K. Doumbo; Louis H. Miller; Allan Saul

doi:10.1016/j.vaccine.2009.03.014

A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

Issaka Sagara, Alassane Dicko, Ruth D. Ellis, Michael P. Fay, Sory I. Diawara, Mahamadoun H. Assadou, Mahamadou S. Sissoko, Mamady Kone, Abdoulbaki I. Diallo, Renion Saye, Merepen A. Guindo, Ousmane Kante, Mohamed B. Niambele, Kazutoyo Miura, Gregory E. D. Mullen, Mark Pierce, Laura B. Martin, Amagana Dolo, Dapa A. Diallo, Ogobara K. DoumboLouis H. Miller, Allan Saul

Imaging Chemistry & Biology

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

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Abstract

A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin

Original language	English
Pages (from-to)	3090 - 3098
Number of pages	9
Journal	Vaccine
Volume	27
Issue number	23
DOIs	https://doi.org/10.1016/j.vaccine.2009.03.014
Publication status	Published - 18 May 2009

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10.1016/j.vaccine.2009.03.014

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Sagara, I., Dicko, A., Ellis, R. D., Fay, M. P., Diawara, S. I., Assadou, M. H., Sissoko, M. S., Kone, M., Diallo, A. I., Saye, R., Guindo, M. A., Kante, O., Niambele, M. B., Miura, K., Mullen, G. E. D., Pierce, M., Martin, L. B., Dolo, A., Diallo, D. A., ... Saul, A. (2009). A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali. Vaccine, 27(23), 3090 - 3098. https://doi.org/10.1016/j.vaccine.2009.03.014

@article{726933809b1c406fa9af65544f8313c9,

title = "A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali",

abstract = "A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin ",

author = "Issaka Sagara and Alassane Dicko and Ellis, {Ruth D.} and Fay, {Michael P.} and Diawara, {Sory I.} and Assadou, {Mahamadoun H.} and Sissoko, {Mahamadou S.} and Mamady Kone and Diallo, {Abdoulbaki I.} and Renion Saye and Guindo, {Merepen A.} and Ousmane Kante and Niambele, {Mohamed B.} and Kazutoyo Miura and Mullen, {Gregory E. D.} and Mark Pierce and Martin, {Laura B.} and Amagana Dolo and Diallo, {Dapa A.} and Doumbo, {Ogobara K.} and Miller, {Louis H.} and Allan Saul",

year = "2009",

month = may,

day = "18",

doi = "10.1016/j.vaccine.2009.03.014",

language = "English",

volume = "27",

pages = "3090 -- 3098",

journal = "Vaccine",

issn = "1873-2518",

publisher = "Elsevier BV",

number = "23",

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Sagara, I, Dicko, A, Ellis, RD, Fay, MP, Diawara, SI, Assadou, MH, Sissoko, MS, Kone, M, Diallo, AI, Saye, R, Guindo, MA, Kante, O, Niambele, MB, Miura, K, Mullen, GED, Pierce, M, Martin, LB, Dolo, A, Diallo, DA, Doumbo, OK, Miller, LH & Saul, A 2009, 'A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali', Vaccine, vol. 27, no. 23, pp. 3090 - 3098. https://doi.org/10.1016/j.vaccine.2009.03.014

TY - JOUR

T1 - A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

AU - Sagara, Issaka

AU - Dicko, Alassane

AU - Ellis, Ruth D.

AU - Fay, Michael P.

AU - Diawara, Sory I.

AU - Assadou, Mahamadoun H.

AU - Sissoko, Mahamadou S.

AU - Kone, Mamady

AU - Diallo, Abdoulbaki I.

AU - Saye, Renion

AU - Guindo, Merepen A.

AU - Kante, Ousmane

AU - Niambele, Mohamed B.

AU - Miura, Kazutoyo

AU - Mullen, Gregory E. D.

AU - Pierce, Mark

AU - Martin, Laura B.

AU - Dolo, Amagana

AU - Diallo, Dapa A.

AU - Doumbo, Ogobara K.

AU - Miller, Louis H.

AU - Saul, Allan

PY - 2009/5/18

Y1 - 2009/5/18

N2 - A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin

AB - A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin

U2 - 10.1016/j.vaccine.2009.03.014

DO - 10.1016/j.vaccine.2009.03.014

M3 - Article

SN - 1873-2518

VL - 27

SP - 3090

EP - 3098

JO - Vaccine

JF - Vaccine

IS - 23

ER -

A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

Abstract

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