A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults

Issaka Sagara; Ruth D. Ellis; Alassane Dicko; Mohamed B. Niambele; Beh Kamate; Ousmane Guindo; Mahamadou S. Sissoko; Michael P. Fay; Merepen A. Guindo; Ousmane Kante; Renion Saye; Kazutoyo Miura; Carole Long; Gregory E. D. Mullen; Mark Pierce; Laura B. Martin; Kelly Rausch; Amagana Dolo; Dapa A. Diallo; Louis H. Miller; Ogobara K. Doumbo; Gregory Mullen

doi:10.1016/j.vaccine.2009.10.087

A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults

Issaka Sagara, Ruth D. Ellis, Alassane Dicko, Mohamed B. Niambele, Beh Kamate, Ousmane Guindo, Mahamadou S. Sissoko, Michael P. Fay, Merepen A. Guindo, Ousmane Kante, Renion Saye, Kazutoyo Miura, Carole Long, Gregory E. D. Mullen, Mark Pierce, Laura B. Martin, Kelly Rausch, Amagana Dolo, Dapa A. Diallo, Louis H. MillerOgobara K. Doumbo, Gregory Mullen

Imaging Chemistry & Biology

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Abstract

A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel(R) with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donegubougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 mu g AMA1-C1 /Alhydrogel(R) or 80 mu g AMA1-C1/Alhydrogel(R) + 564 mu g CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all p < 0.05). This is the first use of the novel adjuvant CPG 7909 in a malaria-exposed population. (C) 2009 Elsevier Ltd. All rights reserved.

Original language	English
Pages (from-to)	7292-7298
Number of pages	7
Journal	Vaccine
Volume	27
Issue number	52
DOIs	https://doi.org/10.1016/j.vaccine.2009.10.087
Publication status	Published - 9 Dec 2009

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10.1016/j.vaccine.2009.10.087

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Sagara, I., Ellis, R. D., Dicko, A., Niambele, M. B., Kamate, B., Guindo, O., Sissoko, M. S., Fay, M. P., Guindo, M. A., Kante, O., Saye, R., Miura, K., Long, C., Mullen, G. E. D., Pierce, M., Martin, L. B., Rausch, K., Dolo, A., Diallo, D. A., ... Mullen, G. (2009). A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults. Vaccine, 27(52), 7292-7298. https://doi.org/10.1016/j.vaccine.2009.10.087

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title = "A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults",

abstract = "A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel(R) with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donegubougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 mu g AMA1-C1 /Alhydrogel(R) or 80 mu g AMA1-C1/Alhydrogel(R) + 564 mu g CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all p < 0.05). This is the first use of the novel adjuvant CPG 7909 in a malaria-exposed population. (C) 2009 Elsevier Ltd. All rights reserved.",

author = "Issaka Sagara and Ellis, {Ruth D.} and Alassane Dicko and Niambele, {Mohamed B.} and Beh Kamate and Ousmane Guindo and Sissoko, {Mahamadou S.} and Fay, {Michael P.} and Guindo, {Merepen A.} and Ousmane Kante and Renion Saye and Kazutoyo Miura and Carole Long and Mullen, {Gregory E. D.} and Mark Pierce and Martin, {Laura B.} and Kelly Rausch and Amagana Dolo and Diallo, {Dapa A.} and Miller, {Louis H.} and Doumbo, {Ogobara K.} and Gregory Mullen",

year = "2009",

month = dec,

day = "9",

doi = "10.1016/j.vaccine.2009.10.087",

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Sagara, I, Ellis, RD, Dicko, A, Niambele, MB, Kamate, B, Guindo, O, Sissoko, MS, Fay, MP, Guindo, MA, Kante, O, Saye, R, Miura, K, Long, C, Mullen, GED, Pierce, M, Martin, LB, Rausch, K, Dolo, A, Diallo, DA, Miller, LH, Doumbo, OK & Mullen, G 2009, 'A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults', Vaccine, vol. 27, no. 52, pp. 7292-7298. https://doi.org/10.1016/j.vaccine.2009.10.087

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T1 - A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults

AU - Sagara, Issaka

AU - Ellis, Ruth D.

AU - Dicko, Alassane

AU - Niambele, Mohamed B.

AU - Kamate, Beh

AU - Guindo, Ousmane

AU - Sissoko, Mahamadou S.

AU - Fay, Michael P.

AU - Guindo, Merepen A.

AU - Kante, Ousmane

AU - Saye, Renion

AU - Miura, Kazutoyo

AU - Long, Carole

AU - Mullen, Gregory E. D.

AU - Pierce, Mark

AU - Martin, Laura B.

AU - Rausch, Kelly

AU - Dolo, Amagana

AU - Diallo, Dapa A.

AU - Miller, Louis H.

AU - Doumbo, Ogobara K.

AU - Mullen, Gregory

PY - 2009/12/9

Y1 - 2009/12/9

N2 - A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel(R) with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donegubougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 mu g AMA1-C1 /Alhydrogel(R) or 80 mu g AMA1-C1/Alhydrogel(R) + 564 mu g CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all p < 0.05). This is the first use of the novel adjuvant CPG 7909 in a malaria-exposed population. (C) 2009 Elsevier Ltd. All rights reserved.

AB - A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel(R) with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donegubougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 mu g AMA1-C1 /Alhydrogel(R) or 80 mu g AMA1-C1/Alhydrogel(R) + 564 mu g CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all p < 0.05). This is the first use of the novel adjuvant CPG 7909 in a malaria-exposed population. (C) 2009 Elsevier Ltd. All rights reserved.

U2 - 10.1016/j.vaccine.2009.10.087

DO - 10.1016/j.vaccine.2009.10.087

M3 - Article

SN - 0264-410X

VL - 27

SP - 7292

EP - 7298

JO - Vaccine

JF - Vaccine

IS - 52

ER -

A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel (R) + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults

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