A double-blind, placebo-controlled phase 1/2a trial of the genetically attenuated malaria vaccine PfSPZ-GA1

Meta Roestenberg; Jona Walk; Saskia C. van der Boor; Marijke C. C. Langenberg; Marie-Astrid Hoogerwerf; Jacqueline J. Janse; Mikhael Manurung; X. Zen Yap; Amanda Fabra García; Jan Pieter R. Koopman; Pauline Meij; Els Wessels; Karina Teelen; Youri M. van Waardenburg; Marga van de Vegte-Bolmer; Geert Jan van Gemert; Leo G. Visser; André J. A. M. van der Ven; Quirijn de Mast; K. C. Natasha; Yonas Abebe; Tooba Murshedkar; Peter F. Billingsley; Tom L. Richie; B. Kim Lee Sim; Chris J. Janse; Stephen L. Hoffman; Shahid M. Khan; Robert W. Sauerwein

doi:10.1126/scitranslmed.aaz5629

Research ArticleMalaria

A double-blind, placebo-controlled phase 1/2a trial of the genetically attenuated malaria vaccine PfSPZ-GA1

View ORCID ProfileMeta Roestenberg¹,²,*,
View ORCID ProfileJona Walk³,⁴,*,
Saskia C. van der Boor³,†,
Marijke C. C. Langenberg¹,†,
View ORCID ProfileMarie-Astrid Hoogerwerf¹,
Jacqueline J. Janse¹,
Mikhael Manurung¹,
X. Zen Yap³,
View ORCID ProfileAmanda Fabra García³,
Jan Pieter R. Koopman¹,
Pauline Meij⁵,
Els Wessels⁶,
Karina Teelen³,
Youri M. van Waardenburg³,
Marga van de Vegte-Bolmer³,
Geert Jan van Gemert³,
View ORCID ProfileLeo G. Visser²,
View ORCID ProfileAndré J. A. M. van der Ven⁴,
Quirijn de Mast⁴,
K. C. Natasha⁷,
Yonas Abebe⁷,
Tooba Murshedkar⁷,
View ORCID ProfilePeter F. Billingsley⁷,
View ORCID ProfileTom L. Richie⁷,
View ORCID ProfileB. Kim Lee Sim⁷,
Chris J. Janse¹,
View ORCID ProfileStephen L. Hoffman⁷,
View ORCID ProfileShahid M. Khan¹,‡,§ and
View ORCID ProfileRobert W. Sauerwein³,‡,||

¹Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.
²Department of Infectious Diseases, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.
³Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.
⁴Radboudumc Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.
⁵Interdivisional GMP Facility, Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.
⁶Department of Medical Microbiology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.
⁷Sanaria Inc., Rockville, MD 20850, USA.

↵||Corresponding author. Email: robert.sauerwein{at}radboudumc.nl

↵* These authors contributed equally to this work.
↵† These authors contributed equally to this work.
↵‡ These authors contributed equally to this work.
↵§ Deceased.

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Science Translational Medicine 20 May 2020:
Vol. 12, Issue 544, eaaz5629
DOI: 10.1126/scitranslmed.aaz5629

Meta Roestenberg

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

2Department of Infectious Diseases, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Jona Walk

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

4Radboudumc Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Saskia C. van der Boor

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Marijke C. C. Langenberg

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Marie-Astrid Hoogerwerf

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Jacqueline J. Janse

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Mikhael Manurung

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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X. Zen Yap

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Amanda Fabra García

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Jan Pieter R. Koopman

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Pauline Meij

5Interdivisional GMP Facility, Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Els Wessels

6Department of Medical Microbiology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Karina Teelen

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Youri M. van Waardenburg

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Marga van de Vegte-Bolmer

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Geert Jan van Gemert

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Leo G. Visser

2Department of Infectious Diseases, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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André J. A. M. van der Ven

4Radboudumc Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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Quirijn de Mast

4Radboudumc Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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K. C. Natasha

7Sanaria Inc., Rockville, MD 20850, USA.

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Yonas Abebe

7Sanaria Inc., Rockville, MD 20850, USA.

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Tooba Murshedkar

7Sanaria Inc., Rockville, MD 20850, USA.

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Peter F. Billingsley

7Sanaria Inc., Rockville, MD 20850, USA.

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Tom L. Richie

7Sanaria Inc., Rockville, MD 20850, USA.

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B. Kim Lee Sim

7Sanaria Inc., Rockville, MD 20850, USA.

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Chris J. Janse

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Stephen L. Hoffman

7Sanaria Inc., Rockville, MD 20850, USA.

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Shahid M. Khan

1Department of Parasitology, Leiden University Medical Center, 2333 ZA Leiden, Netherlands.

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Robert W. Sauerwein

3Radboudumc Center for Infectious Diseases, Department of Medical Microbiology, Radboud University Medical Center, 6525 GA Nijmegen, Netherlands.

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For correspondence: robert.sauerwein@radboudumc.nl

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A double-blind, placebo-controlled phase 1/2a trial of the genetically attenuated malaria vaccine PfSPZ-GA1

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