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Transcription profiling of PfSPZ Vaccine trial subjects (US, malaria naïve) receiving a 3-dose or 5-dose regimen

ABSTRACT: Transcription profiling of PfSPZ Vaccine trial subjects (US, malaria naïve) receiving a 3-dose or 5-dose regimen

PROVIDER: PRJNA871225 | ENA |

REPOSITORIES: ENA

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			Action	DRS
	SRR21145525_1.fastq.gz	Fastqsanger.gz
	SRR21145525_2.fastq.gz	Fastqsanger.gz
	SRR21145526_1.fastq.gz	Fastqsanger.gz
	SRR21145526_2.fastq.gz	Fastqsanger.gz
	SRR21145527_1.fastq.gz	Fastqsanger.gz

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Transcription profiling of PfSPZ Vaccine trial subjects (US, malaria naïve) receiving a 3-dose or 5-dose regimen

Project description:The Sanaria® PfSPZ Vaccine can confer sterilizing protection against liver stage infection by Plasmodium falciparum (Pf) in malaria naïve individuals. The vaccine consists of aseptically purified irradiated Pf sporozoites. Vaccinees received either 3 doses of 1.8M irradiated sporozoites or 5 doses of 270K. Efficacy was measured by challenged by controlled human malaria infections (CHMI) at 3 weeks and 24 weeks after the last vaccine dose

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Transcription profiling of PfSPZ Malaria Vaccine trial subjects receiving a 3-dose regimen in a malaria endemic region

Project description:Transcription profiling of PfSPZ Malaria Vaccine trial subjects receiving a 3-dose regimen in a malaria endemic region

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Transcription profiling of PfSPZ Malaria Vaccine trial subjects receiving a 3-dose regimen in a malaria endemic region

Project description:The Sanaria® PfSPZ Vaccine can confer sterilizing protection against liver stage infection by Plasmodium falciparum (Pf) in malaria naïve individuals. The vaccine consists of aseptically purified irradiated Pf sporozoites. Vaccinees received 3 doses of 1.8 X 106 irradiated sporozoites. Efficacy was measured by challenged by controlled human malaria infections (CHMI), and against naturally occurring Pf Infections in Malian adults during the malaria transmission season

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Transcription profiling of PfSPZ Malaria Vaccine trial subjects in a malaria endemic region

Project description:The Sanaria® PfSPZ Vaccine can confer sterilizing protection against liver stage infection by Plasmodium falciparum (Pf) in malaria naïve individuals. The vaccine consists of aseptically purified irradiated Pf sporozoites. The PfSPZ Vaccine trial in Mali was the first to evaluate the safety and efficacy of this vaccine in a malaria endemic region. Vaccinees received five doses of 2.7 X 105 irradiated sporozoites and the efficacy was measured against naturally occurring Pf Infections in Malian adults during the malaria transmission season.

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Heterologous protection against malaria by a simple chemoattenuated PfSPZ vaccine regimen in a randomized trial.

Project description:Immunization with Plasmodium falciparum (Pf) sporozoites under chemoprophylaxis (PfSPZ-CVac) is the most efficacious approach to malaria vaccination. Implementation is hampered by a complex chemoprophylaxis regimen and missing evidence for efficacy against heterologous infection. We report the results of a double-blinded, randomized, placebo-controlled trial of a simplified, condensed immunization regimen in malaria-naive volunteers (EudraCT-Nr: 2018-004523-36). Participants are immunized by direct venous inoculation of 1.1 × 105 aseptic, purified, cryopreserved PfSPZ (PfSPZ Challenge) of the PfNF54 strain or normal saline (placebo) on days 1, 6 and 29, with simultaneous oral administration of 10 mg/kg chloroquine base. Primary endpoints are vaccine efficacy tested by controlled human malaria infection (CHMI) using the highly divergent, heterologous strain Pf7G8 and safety. Twelve weeks following immunization, 10/13 participants in the vaccine group are sterilely protected against heterologous CHMI, while (5/5) participants receiving placebo develop parasitemia (risk difference: 77%, p = 0.004, Boschloo's test). Immunization is well tolerated with self-limiting grade 1-2 headaches, pyrexia and fatigue that diminish with each vaccination. Immunization induces 18-fold higher anti-Pf circumsporozoite protein (PfCSP) antibody levels in protected than in unprotected vaccinees (p = 0.028). In addition anti-PfMSP2 antibodies are strongly protection-associated by protein microarray assessment. This PfSPZ-CVac regimen is highly efficacious, simple, safe, well tolerated and highly immunogenic.

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Project description:This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ Vaccine) administered intravenously (IV).

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