Providing Ancillary Care in Clinical Research: A Case of Diffuse Large B-Cell Lymphoma during a Malaria Vaccine Trial in Equatorial Guinea

Providing medical care for participants in clinical trials in resource-limited settings can be challenging and costly. Evaluation and treatment of a young man who developed cervical lymphadenopathy during a malaria vaccine trial in Equatorial Guinea required concerted efforts of a multinational, mul...

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Published inThe American journal of tropical medicine and hygiene Vol. 104; no. 2; pp. 695 - 699
Main Authors Manock, Stephen R, Mtoro, Ali, Urbano Nsue Ndong, Vicente, Olotu, Ally, Chemba, Mwajuma, Sama Roca, Antonio E, Eburi, Esther, García, Guillermo A, Cortes Falla, Carlos, Niemczura de Carvalho, Julie, Contreras, Jaime, Saturno, Baltasar, Riocalo, Juan de Dios, Nze Mba, José Luis, Koka, Rima, Lee, Seung Tae, Menon, Hari, Church, L W Preston, Ayekaba, Mitoha Ondo'o, Billingsley, Peter F, Abdulla, Salim, Richie, Thomas L, Hoffman, Stephen L
Format Journal Article
LanguageEnglish
Published United States Institute of Tropical Medicine 01.02.2021
The American Society of Tropical Medicine and Hygiene
Subjects
Adult
Ancillary Services, Hospital
Clinical Trials, Phase I as Topic
Equatorial Guinea - epidemiology
Humans
India
Lymphoma
Lymphoma, Large B-Cell, Diffuse - diagnosis
Lymphoma, Large B-Cell, Diffuse - therapy
Malaria
Malaria - epidemiology
Malaria - prevention & control
Malaria Vaccines - administration & dosage
Male
Tertiary Care Centers
Vaccines
Equatorial Guinea
India
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Summary:Providing medical care for participants in clinical trials in resource-limited settings can be challenging and costly. Evaluation and treatment of a young man who developed cervical lymphadenopathy during a malaria vaccine trial in Equatorial Guinea required concerted efforts of a multinational, multidisciplinary team. Once a diagnosis of diffuse large B-cell lymphoma was made, the patient was taken to India to receive immunochemotherapy. This case demonstrates how high-quality medical care was provided for a serious illness that occurred during a trial that was conducted in a setting in which positron emission tomography for diagnostic staging, an oncologist for supervision of treatment, and an optimal therapeutic intervention were not available. Clinical researchers should anticipate the occurrence of medical conditions among study subjects, clearly delineate the extent to which health care will be provided, and set aside funds commensurate with those commitments.
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Disclosure: S. L. H., T. L. R., P. F. B., and L. W. P. C. are employed by Sanaria, Inc., which developed PfSPZ Vaccine and PfSPZ-CVac. S. R. M. was employed by Sanaria, Inc. at the time of the clinical trial, but was not at the time the manuscript was prepared and submitted. A. O. was the recipient of a U.K. Medical Research Council African Research Leader award for work unrelated to this manuscript.
Disclaimer: Funders did not contribute to study design, or to the collection, analysis, or interpretation of data, the writing of the manuscript, or the decision to submit it for publication.
Financial support: The government of Equatorial Guinea, Marathon E.G. Production Limited, Noble Energy Equatorial Guinea, and Atlantic Methanol Production Company LLC provided funding for the clinical trial and treatment of this patient.
Authors’ addresses: Stephen R. Manock, Department of Family Medicine, John Peter Smith Hospital, Fort Worth, TX and Sanaria, Inc., Rockville, MD, E-mail: smanock@jpshealth.org. Ali Mtoro, Mwajuma Chemba, and Salim Abdulla, Ifakara Health Institute, Bagamoyo, Tanzania, E-mails: amtoro@ihi.or.tz, mchemba@ihi.or.tz, and sabdulla@ihi.or.tz. Vicente Urbano Nsue Ndong and Mitoha Ondo’o Ayekaba, Ministry of Health and Social Welfare, Malabo, Equatorial Guinea, E-mails: viceurb2013@gmail.com and mitoha_ondo@yahoo.com. Ally Olotu, Ifakara Health Institute, Bagamoyo, Tanzania and KEMRI Wellcome Trust Research Programme, Kilifi, Kenya. E-mails: ndaskoiolotu@gmail.com or aolotu@ihi.or.tz. Antonio E. Sama Roca, Esther Eburi, and Carlos Cortes Falla, Medical Care Development International, Malabo, Equatorial Guinea, E-mails: rocantony@gmail.com, eeburi@mcd.org, and ccortes@mcd.org. Guillermo A. García and Julie Niemczura de Carvalho, Medical Care Development International, Silver Spring, MD, E-mails: ggarcia@mcd.org and jniemczura@mcd.org. Jaime Contreras, Baltasar Saturno, and Juan de Dios Riocalo, La Paz Medical Center, Malabo, Equatorial Guinea, E-mails: jaimecdoc@gmail.com, baltasarsaturno@gmail.com, and doctorriocalo@gmail.com. José Luis Nze Mba, Policlínico Dr. Loeri Comba, Instituto de Seguridad Social, Malabo, Equatorial Guinea, E-mail: joseluisnzemba@gmail.com. Rima Koka and Seung Tae Lee, University of Maryland Medical Center, Baltimore, MD, E-mails: mkoka@umm.edu and seunglee@umm.edu. Hari Menon, Cytecare Cancer Hospital, Bengaluru, Karnataka, India, E-mail: hari.menon@cytecare.com. L. W. Preston Church, Peter F. Billingsley, Thomas L. Richie, and Stephen L. Hoffman, Sanaria, Inc., Rockville, MD, E-mails: lwpchurch@sanaria.com, pbillingsley@sanaria.com, trichie@sanaria.com, and slhoffman@sanaria.com.
ISSN:0002-9637
1476-1645
DOI:10.4269/ajtmh.20-1178