Replication Data for: The malaria vaccine R21 is protective against intradermal but not intravenous Plasmodium falciparum sporozoites in controlled human malaria infection in Kenyan adults (doi:10.7910/DVN/TNHS14)

View:

Part 1: Document Description
Part 2: Study Description
Part 5: Other Study-Related Materials
Entire Codebook

Document Description

Citation

Title:

Replication Data for: The malaria vaccine R21 is protective against intradermal but not intravenous Plasmodium falciparum sporozoites in controlled human malaria infection in Kenyan adults

Identification Number:

doi:10.7910/DVN/TNHS14

Distributor:

Harvard Dataverse

Date of Distribution:

2024-07-29

Version:

3

Bibliographic Citation:

Kapulu, Melissa C.; Orenge, Francesca; Kimani,Domtila; Kibwana, Elizabeth; Kibet Hillary; Mutahi, Mary; Datoo, Mehreen S.; Bellamy, Duncan; Musembi, Janet; Ngoto, Omar; Rashid, Hamisi; Akinyi, Stellamaris; Mwatasa, Mwaganyuma; Nyamako, Lydia; Keter, Kelvias; Gatheru, Rose; Mutiso, Agnes; Musyoki, Jennifer; Mwacharo, Jedidah; Abebe, Yonas; James, Eric J.; Billingsley, Peter F.; Ngetsa, Caroline; Mosobo, Moses; Makale, Johnstone; Tawa, Brian; Wamae, Kevin; Ochola-Oyier, Lynette I.; Wambua, Juliana; Lawrie, Alison; Ramos-Lopez, Fernando; Roberts, Rachel; Richie, Thomas L.; Sim, B. Kim Lee; Hoffman, Stephen L.; Ewer, Katie J.; Hill, Adrian V. S.; Hamaluba, Mainga.; Bejon, Philip, 2024, "Replication Data for: The malaria vaccine R21 is protective against intradermal but not intravenous Plasmodium falciparum sporozoites in controlled human malaria infection in Kenyan adults", https://doi.org/10.7910/DVN/TNHS14, Harvard Dataverse, V3, UNF:6:uSl7BVIrsuW6q3SVxM0ARA== [fileUNF]

Study Description

Citation

Title:

Replication Data for: The malaria vaccine R21 is protective against intradermal but not intravenous Plasmodium falciparum sporozoites in controlled human malaria infection in Kenyan adults

Identification Number:

doi:10.7910/DVN/TNHS14

Authoring Entity:

Kapulu, Melissa C. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Orenge, Francesca (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Kimani,Domtila (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Kibwana, Elizabeth (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Kibet Hillary (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Mutahi, Mary (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Datoo, Mehreen S. (Jenner Institute, University of Oxford, United Kingdom)

Bellamy, Duncan (Jenner Institute, University of Oxford, United Kingdom)

Musembi, Janet (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Ngoto, Omar (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Rashid, Hamisi (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Akinyi, Stellamaris (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Mwatasa, Mwaganyuma (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Nyamako, Lydia (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Keter, Kelvias (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Gatheru, Rose (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Mutiso, Agnes (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Musyoki, Jennifer (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Mwacharo, Jedidah (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Abebe, Yonas (Sanaria Inc., Rockville, MD, USA)

James, Eric J. (Sanaria Inc., Rockville, MD, USA)

Billingsley, Peter F. (Sanaria Inc., Rockville, MD, USA)

Ngetsa, Caroline (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Mosobo, Moses (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Makale, Johnstone (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Tawa, Brian (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Wamae, Kevin (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Ochola-Oyier, Lynette I. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Wambua, Juliana (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Lawrie, Alison (Jenner Institute, University of Oxford, United Kingdom)

Ramos-Lopez, Fernando (Jenner Institute, University of Oxford, United Kingdom)

Roberts, Rachel (Jenner Institute, University of Oxford, United Kingdom)

Richie, Thomas L. (Sanaria Inc., Rockville, MD, USA)

Sim, B. Kim Lee (Sanaria Inc., Rockville, MD, USA)

Hoffman, Stephen L. (Sanaria Inc., Rockville, MD, USA)

Ewer, Katie J. (Jenner Institute, University of Oxford, United Kingdom)

Hill, Adrian V. S. (Jenner Institute, University of Oxford, United Kingdom)

Hamaluba, Mainga. (Jenner Institute, University of Oxford, United Kingdom)

Bejon, Philip (Jenner Institute, University of Oxford, United Kingdom)

Distributor:

Harvard Dataverse

Access Authority:

Kapulu, Melissa C.

Access Authority:

The Data Governance Committee

Depositor:

Kapulu, Melissa C.

Date of Deposit:

2024-07-19

Holdings Information:

https://doi.org/10.7910/DVN/TNHS14

Study Scope

Keywords:

Medicine, Health and Life Sciences

Abstract:

<p>This is a replication dataset for the manuscript titled: "<strong><i>The malaria vaccine R21 is protective against intradermal but not intravenous Plasmodium falciparum sporozoites in controlled human malaria infection in Kenyan adults.</i></strong>"</p> <p>We undertook controlled human malaria infections in volunteers vaccinated with the PfCSP-based vaccine R21/Matrix-M, using either intradermal injection (ID) or direct venous inoculation (DVI) of P. falciparum sporozoites (PfSPZ Challenge).</p> <p>Data package contains: <li>Elisa data - calculation of levels of anti-whole schizont antibody (3D7 strain) for comparison amongst the R21/Matrix M ID, R21/Matrix-M DVI, Control ID and control DVI groups</li> <li>PCR data - quantification the malaria parasites for comparison amongst the R21/Matrix M ID, R21/Matrix-M DVI, Control ID and control DVI groups.</li> <li>safety data - contains safety blood variables, their levels and tests.</li> <li>AE data - contains unsolicited Adverse Events.</li> </p>

Kind of Data:

Restricted Access

Notes:

<p><strong>Data Access: </strong>Restricted</p> <p>Access to these data requires submission of a formal request for consideration by our Data Governance Committee. </p> <strong>How to request</strong> <ol> <li>Download and complete the <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx"><strong>data request form</strong></a></li> <li> Email completed data request form to the Data Governance Committee at <a href="mailto:dgc@kemri-wellcome.org?cc=lmwango@kemri-wellcome.org?Subject=Data%20Access%20Request"><strong>dgc@kemri-wellcome.org</strong></a> </li> </ol>

Methodology and Processing

Sources Statement

Data Access

Notes:

Access to these data requires submission of a formal request for consideration by our Data Governance Committee. Please download and complete the <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx"><strong>data request form</strong></a> and send to the Data Governance Committee at <a href="mailto:dgc@kemri-wellcome.org?Subject=Data%20Access%20Request"><strong>dgc@kemri-wellcome.org</strong></a>

Other Study Description Materials

Other Study-Related Materials

Label:

Analysis code.zip

Notes:

application/zip

Other Study-Related Materials

Label:

ICF_CRFs.zip

Notes:

application/zip

Other Study-Related Materials

Label:

R21_data_csv.zip

Notes:

application/zip

Other Study-Related Materials

Label:

R21_data_stata.zip

Notes:

application/zip

Other Study-Related Materials

Label:

R21_Malaria_Vaccine_MKapulu_Data Dictionary.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

R21_Malaria_Vaccine_MKapulu_Data Dictionary.xlsx

Notes:

application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Other Study-Related Materials

Label:

VAC074 R21-CHMI Protocol Version 1.5 dated 6Apr2022.pdf

Notes:

application/pdf