Duffy Vaccine Development Research Group

LMIV Vaccine Development Unit develops and performs clinical evaluation of prototype malaria vaccines. Each candidate vaccine must undergo a rigorous development process that requires input from many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, clinical good manufacturing practices (cGMP) production, formulation, quality control, preclinical testing, and clinical trials.

This product-oriented research differs from investigator-initiated research conducted in most laboratories. The need for multiple, highly technical inputs makes it impractical to have a single person knowledgeable in all aspects of a specific product.

For these reasons, the unit has adopted an organizational structure used by most biotechnology companies to conduct this development process. This model incorporates best practices from both public and private sectors to rapidly advance vaccine products into Phase II clinical trials. Our organizational approach is coupled with creative management practices, allowing us to operate and fund the program within the framework of the federal government. In addition, the LMIV collaborates with numerous private and public research organizations across the globe; see a comprehensive list of collaborating organizations and the research topics conducted with each.

The Vaccine Development Unit has focused research to eradicate malaria through development of a vaccine to interrupt malaria transmission (VIMT), including transmission-blocking components and pre-erythrocytic components. Another goal of the Vaccine Development Unit is to design and develop vaccines specifically to protect pregnant women and their infants.

Animal Studies Unit

The Animal Studies Unit (headed by Lynn Lambert) conducts pre-clinical studies of novel malaria antigens in small mammals and non-human primates. The animal studies unit collects samples from animals for further testing by various LMIV lab groups. The animal team also develops novel animal models to study malaria infections, malaria disease, and maintains rodent breeding colonies and Plasmodium parasites life cycles.

Lynn Lambert

Animal Resources Manager

Contact: For contact information, search the NIH Enterprise Directory.

Education:

RLATg, CMAR

Lynn Lambert has headed the Animal Studies Unit for 22 years, ensuring the safety and welfare of laboratory animals. She works directly with the Animal Care and Use Committee to ensure compliance with all animal regulations. She also leads contract staff to conduct technical procedures.

Learn more about Lynn Lambert

Holly McAleese, B.S.

Research Support Specialist III

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.S., Animal and Poultry Sciences, Virginia Polytechnic Institute and State University

Member of the animal studies unit that assists PI’s and Post docs from various LMIV lab groups with the development and management of approved animal protocols, collect and organizes data and performs all technical procedures required to achieve completion of studies.

Learn more about Holly McAleese, B.S.

Sachy Orr-Gonzalez

Research Support Specialist IV

Contact: For contact information, search the NIH Enterprise Directory.

Education:

RLATg, CMAR

Languages Spoken: Spanish

Member of the animal studies unit that assists PI’s and Post docs from various LMIV lab groups with the development and management of approved animal protocols, collect and organizes data and performs all technical procedures required to achieve completion of studies.

Learn more about Sachy Orr-Gonzalez

Tarik Ouahes, B.S.

Research Support Specialist III

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.S., Biological Sciences, University of Maryland Baltimore

Languages Spoken: French

Member of the animal studies unit that assists PI’s and Post docs from various LMIV lab groups with the development and management of approved animal protocols, collect and organizes data and performs all technical procedures required to achieve completion of studies.

Learn more about Tarik Ouahes, B.S.

Alaysies Queen

Research Support Specialist III

Contact: For contact information, search the NIH Enterprise Directory.

Education:

LATg

Languages Spoken: French

Member of the animal studies unit that assists PI’s and Post docs from various LMIV lab groups with the development and management of approved animal protocols, collect and organizes data and performs all technical procedures required to achieve completion of studies.

Learn more about Alaysies Queen

Brandi Richardson, M.S.

Research Support Specialist III

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Physiology and Biophysics, University of Illinois Chicago

B.S., Animal Sciences, Purdue University

Member of the animal studies unit that assists PI’s and Post docs from various LMIV lab groups with the development and management of approved animal protocols, collect and organizes data and performs all technical procedures required to achieve completion of studies.

Learn more about Brandi Richardson, M.S.

Myesha Singleton, B.S.

Research Support Specialist II

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.S., Animal and Poultry Sciences, Virginia Polytechnic Institute and State University

A.S., Northern Virginia Community College

Member of the animal studies unit that assists PI’s and Post docs from various LMIV lab groups with the development and management of approved animal protocols, collect and organizes data and performs all technical procedures required to achieve completion of studies.

Learn more about Myesha Singleton, B.S.

Conjugation Development Unit

The Conjugation Development Unit (CDU, headed by Puthupparampil V. Scaria) focuses on development of malaria vaccine candidates targeting different stages of malaria parasite life cycle. CDU has developed a protein-protein conjugate nanoparticle technology to deliver malaria antigens. This technology has been employed in developing transmission blocking, pre-erythrocytic and pregnancy malaria vaccines. Utility of this vaccine technology has been demonstrated in successful clinical trials of transmission blocking vaccine in malaria endemic areas. CDU continue to work on further improving the efficacy of this vaccine as well as combination of it with anti-infection vaccine with a goal to develop a multistage vaccine that may contribute to elimination of malaria. In addition, CDU explores novel vaccine technologies including mRNA, liposomes, VLP etc. for malaria vaccines through external collaborations and internal development.

Puthupparampil V. Scaria, Ph.D.

Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., Delhi University

Languages Spoken: Malayalam

Have extensive experience in the research and development of Nanoparticle delivery technologies for therapeutic and vaccine candidates in academic and industrial environments. Currently heading the Conjugation Development Unit at LMIV to develop new Malaria vaccine candidates employing protein-protein conjugate nanoparticle technology, as well as developing and evaluating new vaccine platforms such as mRNA technology through internal development and external collaborations.

Learn more about Puthupparampil V. Scaria, Ph.D.

Beth Chen, M.S.

Senior Research Associate

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Education:

M.S., Biochemistry, Shanghai Institute of Pharmaceutical Industry

Languages Spoken: Chinese

Malaria vaccine development by protein, peptide and Oligo modification and conjugation. Conjugates and Protein purification by using AKATA(FPLC) to make final product of the vaccine. Protein, peptides and Oligo analysis by UPLC, HPLC, MALS, SDS-PAGE, western blot etc.

Learn more about Beth Chen, M.S.

Christopher G. Rowe, M.S.

Microbiologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Biotechnology, Johns Hopkins University

B.S., Biological Sciences, UMBC

Malaria vaccine development by protein, peptide and Oligo modification and conjugation. Assay development to determine molar substitution ratios, conjugate composition by amino acid analysis.

Learn more about Christopher G. Rowe, M.S.

Clinical Trials Unit

The Clinical Trials Unit (headed by David Cook) conducts clinical trials in the United States and Africa. The clinical team assists in the design and planning for all LMIV human clinical studies, including observational studies, experimental medicine studies such as controlled human infections, and interventional trials to assess vaccine safety, immunogenicity, and efficacy.  The clinical team coordinates all activities required to initiate, conduct, manage, and oversee all aspects associated with vaccine trials, including initiation, enrollment period, study close out, data cleaning, and reporting.

David Mack Cook, M.D.

Clinical Fellow/Medical Officer

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.D., Uniformed Services University, Bethesda, MD

Residency, Walter Reed National Military Medical Center, Bethesda, MD

B.S., Brigham Young University, Provo, UT

Lead investigator on several clinical trials, including trials of malaria whole organism vaccines, transmission blocking vaccines, and induced blood stage vivax malaria models in the U.S. and Mali. Lead investigator on several non-IND clinical studies, including investigations of malaria prevalence in vulnerable populations (pregnant women and infants) in Mali, Liberia, and Guinea. Associate investigator or medical advisory investigator on several clinical studies in the U.S., Mali, Liberia, Guinea, and Burkina Faso. Mentor to post-bac students, medical students, and clinical fellows in the CTU.

Learn more about David Mack Cook, M.D.

Maria Conner, MPS, CAPM

Project Manager

Contact: For contact information, search the NIH Enterprise Directory.

Education:

MPS, Project Management, Georgetown University

CAPM, Project Management Institute

B.S., Biology, Mount St. Mary’s University

Background in biology and chemistry with research lab experience. Trained and credentialed in project management with special focus on domestic and international clinical trial planning and operations.

Learn more about Maria Conner, MPS, CAPM

Aye D. Diallo, PA

Clinical Research Physician Assistant

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Physician Assistant Studies, Philadelphia University

B.S., Biology, George Washington University 

Languages Spoken: French, Fulah

Working at LMIV to help advance human clinical studies for Malaria vaccines. Currently coordinating international clinical trials for a vaccine candidate in pregnant women in Mali and for future vaccine trials in Guinea. Also assisting with the conduct of studies at the clinical center.

Learn more about Aye D. Diallo, PA

Viyada Doan, M.S.

Clinical Data Manager

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., University of Maryland University College

Languages Spoken: Thai

I worked as a data manager at the NIH/Fogarty International Center, managing the Malnutrition and Enteric Disease (Mal-ED) cohort study database for 8 years. My current projects are clinical trials of PfSPZ Vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).

Learn more about Viyada Doan, M.S.

Judith Eastwick Epstein, M.D.

Clinical Investigator

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Education:

M.D., Harvard Medical School
B.S., Columbia University 
Barnard College

Dr. Epstein’s research has focused on development of a vaccine to prevent malaria. This has included work on attenuated whole organism vaccines to prevent infection as well as transmission blocking vaccines.

Learn more about Judith Eastwick Epstein, M.D.

Joel Goldberg, M.D., Ph.D.

Clinical Fellow

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.D., Tulane University

Ph.D., The Scripps Research Institute

Interested in clinical trials and global health. Associate investigator on LMIV malaria trials against P falciparum in Mali and P vivax at the NIH clinical center.

Learn more about Joel Goldberg, M.D., Ph.D.

Sara A. Healy, M.D., MPH

Staff Clinician

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.D., Tulane University School of Medicine

MPH, International Health and Development, Tulane University School of Public Health and Tropical Medicine

B.S., Biology, Drake University

Collaborating with colleagues across West Africa, Dr. Healy currently runs multiple phase 1 and 2 studies evaluating malaria vaccines. Her research is focused on designing and executing malaria transmission blocking vaccine clinical trials, vaccines to interrupt malaria transmission, and strategies to prevent malaria infection in pregnant women.

Learn more about Sara A. Healy, M.D., MPH

Emily Higbee, M.S.P.H.

Clinical Research Coordinator

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Tulane University School of Public Health

B.S., Zoology, Spanish, University of Wisconsin Madison

I have been a clinical study coordinator with LMIV since 2020. I currently work on both domestic and international projects, where I support the study conduct and help facilitate the day-to-day activities. Previously, I worked as a biologist with LMIV where I coordinated international entomology projects and assisted in the standard membrane mosquito feeding assays.

Learn more about Emily Higbee, M.S.P.H.

Alemush Imeru, MPH

Clinical Coordinator

Contact: For contact information, search the NIH Enterprise Directory.

Education:

MPH, Boston University

BSBA, Suffolk University

Languages Spoken: Amharic, French

I have been actively involved in malaria vaccine development, clinical research operations, and management for over 14 years. As a result, I have extensive subject matter knowledge relating to clinical research, enabling me to lead the formation and execution of policies and guidance documents.

Learn more about Alemush Imeru, MPH

Rathy Mohan, M.S.

Lead Data Coordinator

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Education:

M.S., Applied Computer Science, Columbus State University

Certification Program, Applied Data Science, MIT

Bachelor of Engineering, SRM University

Languages Spoken: Tamil, Malayalam , Telugu

Currently working on multiple protocols, providing support from developing CRFs, setting up the database, user training, running DSMB/SRCP reports, and working with PIs and other team members on data requests.

Learn more about Rathy Mohan, M.S.

Regina White, M.L.A., M.S., CCRP

Clinical Trials Coordinator

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Johns Hopkins University

M.L.A., Johns Hopkins University

E.S, B.A., University of Maryland

Certified Clinical Research Professional

Extensive experience in Clinical Research Administration, Regulatory Affairs and Management and Supervision of Research Coordinators. Currently providing guidance and regulatory support to LMIV Investigators and study teams for protocol development, preparation of initial submissions to the IRB as well as protocol maintenance applications for amendments, annual progress reports, safety reports and...

Learn more about Regina White, M.L.A., M.S., CCRP

John Woodford, MBBS, Ph.D.

Staff Clinician

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., University of Queensland, Australia

MBBS (Hons), University of Queensland, Australia

B.Sc., University of Queensland, Australia

Establishing human malaria challenge models for accelerated testing of early phase interventions for falciparum and vivax malaria prior to field studies. Helping respond to the pandemic by integrating COVID-19 epidemiology studies into the malaria research agenda in Mali, West Africa.

Learn more about John Woodford, MBBS, Ph.D.

Entomology Unit

The Entomology Unit (headed by Jen C.C. Hume) manages all the entomological assays conducted by LMIV both in the US and at field sites overseas. These include Standard Membrane Feeding Assays (SMFA), Direct Skin Feeding Assays (DSF), Direct Membrane Feeding Assays (DMFA), live mosquito collections, mosquito spray catches and mosquito mark-release-recapture studies. The unit manages new state of the art insectary facilities on the NIH main campus to support LMIV assays and provide capacity for conducting P. falciparum Controlled Human Malaria Infection (CHMI) studies as well as mosquito feeding assays for evaluating P. vivax transmission blocking vaccines using the Induced Blood Stage Malaria (IBSM) model.

Jen C. C. Hume, DPhil

Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

DPhil, Malaria Transmission, 2005, University of Oxford, UK

B.Sc., 1st Class Honors, Parasitology, 1999, University of Glasgow, UK

Languages Spoken: French

Dr Hume set up and managed her first insectary at the University of Oxford during her doctoral studies and over the past 20 years has worked in a number of institutions and insectaries worldwide. A parasitologist by training, her particular area of interest is malaria transmission, a fascinating intersection of malaria parasites, mosquitoes and their reluctant human host. Dr Hume previously...

Learn more about Jen C. C. Hume, DPhil

Heather Goodman, ScM

Laboratory Research Coordinator

Contact: For contact information, search the NIH Enterprise Directory.

Education:

ScM, Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health

B.S., Chemistry/Biochemistry, Virginia Commonwealth University

My research interests are vector biology and vector ecology, and mosquito-borne diseases. I am involved with various aspects of our onsite research on the NIH campus including SMFAs and maintaining our insectary. Additionally, I support and help coordinate entomological activities for our international TBV clinical studies with our colleagues overseas.

Learn more about Heather Goodman, ScM

Olga V. Muratova, M.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Physiology, 1981, Lomonosov Moscow State University Faculty of Biology

Languages Spoken: Russian

Olga Muratova has been working in malaria research for more than 30 years. She contributed to development, standardization and optimization of multiple laboratory assays and techniques, including malaria parasites culture and gametocyte production, GIA, ELISA, IFA and Membrane-Feeding assay. Olga’s main focus is malaria transmission-blocking vaccine development.

Learn more about Olga V. Muratova, M.S.

Edward S. Owen, B.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.S., Biology, Pennsylvania State University

My research focus has been parasitology, specifically malaria and means of combatting it. I have worked previously on finding novel pharmaceutical means of treatment and combatting resistance, and currently am dedicated to supporting the mission of developing and deploying highly efficacious malaria vaccines as part of LMIV through the use of SMFA’s and maintaining our insectary.

Learn more about Edward S. Owen, B.S.

Formulation Unit

The Formulation Unit (headed by Kelly Rausch) develops formulations for pre-clinical animal studies of vaccines, and coordinates with external partners to incorporate proprietary or commercial adjuvants into LMIV vaccine products.  The formulation unit performs optimization experiments for formulations as well as stability and integrity experiments on pre-clinical materials and develops the pilot scale procedures that are transferred for cGMP manufacturing of vaccines for LMIV clinical trials. The formulation unit oversees the production of the cGMP manufacture at contracted facilities and the submission to appropriate regulatory authorities for clinical use of the vaccine. The formulation unit also produces, in conjunction with field sites pharmacy teams, the SOPs and trainings required for the shipment, storage, and administration of the vaccines for clinical protocols.

Kelly Rausch, M.S.

Formulation and Product Specialist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Life Science, Chemistry, Biology, 2007, University of Maryland, College Park

B.S., Biology, 1996, Virginia Tech

I am a biologist with a broad background and interest in natural biological systems, entomology, evolutionary biology, and bioprocesses, specifically in how these areas apply to malaria vaccine development. I work with LMIV Teams and external collaborators to provide the best potential formulations for various malaria vaccine concepts with the expectation to deliver a stable cGMP manufactured...

Learn more about Kelly Rausch, M.S.

Emma K. Barnafo, M.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Chemical and Life Sciences, 2011, University of Maryland, College Park

B.S., Biochemistry/Biotechnology, 2001, Michigan State University, East Lansing, Michigan

Languages Spoken: Akan, French

I work on multiple projects that involve the preclinical formulation and development of a vaccine that reduces malaria transmission by at least 80% for the duration of one season.

Learn more about Emma K. Barnafo, M.S.

Immune and Molecular Assay Unit

The Immune and Molecular Assay Unit (headed by Irfan Zaidi) performs immunological and molecular assays on pre-clinical and clinical samples.  These studies include ELISA, Binding Inhibition Assays (BIA), Flow Cytometry, and PCR assays. In addition, the immunology department manages pre-clinical and clinical sample inventories, and the molecular assays team prepares samples for next generation sequencing.

Irfan Zaidi, Ph.D.

Senior Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., Biological Sciences, Open University, UK

M.S., Applied Molecular Microbiology, University of Nottingham, UK

B.S. (HONS), Biochemistry, University of Wales, Cardiff, UK

Languages Spoken: Urdu, Hindi, Kiswahili

Infectious diseases immunologist with an extensive background in innate and adaptive immunology, immunophenotyping, vaccines and correlative studies. My current interests include understanding the mechanisms for generating sterile immunity against malaria infections.

Learn more about Irfan Zaidi, Ph.D.

Nada Arabi Hamdo Alani, M.S.

Senior Research Associate

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Microbiology, AlMustansiriyah University, Baghdad, Iraq

B.S., Science/Biology, AlMustansiriyah University, Baghdad, Iraq

Languages Spoken: Arabic, Dutch

Expertise in serology assays that are used to evaluate humoral responses induced by malaria vaccines.

Learn more about Nada Arabi Hamdo Alani, M.S.

Yai A. J. Doritchamou, Ph.D.

Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., Universite Paris Descartes , France

M.Sc., Universite d’Abomey-Calavi, Benin

B.Sc., Biomedical Assistant Engineer Diploma, Universite d’Abomey-Calavi, Benin

Languages Spoken: French

A vaccine scientist with deep knowledge of pregnancy malaria pathogenesis and immunity, and a passion to develop new interventions including therapeutic antibodies to protect pregnant women and their fetuses from this scourge. Current research activities aim at identifying antigen targets of functional human monoclonal antibodies that might be used to optimize vaccine design to protect pregnant women from placental malaria.

Learn more about Yai A. J. Doritchamou, Ph.D.

Junhui Duan, Ph.D.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., Showa University, Japan

Languages Spoken: Chinese

Skilled in molecular biology and biochemistry techniques, and her research projects are involved in malaria vaccine development and disease control.

Learn more about Junhui Duan, Ph.D.

Kendrick Lionell Highsmith, M.S.

Senior Research Associate

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Biotechnology Studies, 2006, University of Maryland Global Campus

B.S., Integrated Science and Technology/Biotechnology, 1999, James Madison University

I am an ASCP certified Flow Cytometry Specialist with 20 years of specialized training in molecular biology and immunology. Presently, I’m currently in the Immunology core lab where I support varies labs within LMIV with flow cytometry and FACS services.

Learn more about Kendrick Lionell Highsmith, M.S.

Pinar Kemanli, M.Sc.

Contractor

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.Sc., Molecular Medicine, Dokuz Eylul University, Izmir, Turkey

B.Sc., Biochemistry, Ege University, Izmir, Turkey 

Languages Spoken: Turkish

My research area is vaccine development for infectious diseases with molecular immunology focus. I am performing immunoassays to support Malaria vaccine development. I am also supporting serological assay optimization for Covid-19.

Learn more about Pinar Kemanli, M.Sc.

Jillian Kyle Neal, B.A.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.A., Biology, 2007, University of Delaware

Laboratory biologist with a background in preclinical toxicology and more than 15 years of research experience who specializes in molecular assay development. Interested in applying innovative technology solutions to traditional research questions.

Learn more about Jillian Kyle Neal, B.A.

Molecular Biology Unit

The Molecular Biology unit (headed by Nicholas MacDonald) lends molecular biology support to LMIV’s projects.  The group is responsible for design of the Pichia and E. coli expression constructs, expMession clones and research cell banks, all of which constitute the vaccine pipeline at LMIV.  The unit manages the generation of the cGMP working and  master cell banks used in vaccine manufacture, and the cell bank testing required for IND submission.

Nicholas J. MacDonald, Ph.D.

Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., Genetics (for research conducted at the University of Zurich), University of Glasgow

M.S., Computer Science, Johns Hopkins University

B.Sc. (Hons)., Molecular Biology, University of Glasgow

Traditional molecular biologists focusing on the design and expression of recombinant malaria vaccine candidates primarily in Pichia and E. coli. Responsible the generation of research cell banks for the LMIV pipeline and overseeing the generation of the cGMP working and master cell banks used in vaccine manufacture, and the cell bank testing required for IND submission.

Learn more about Nicholas J. MacDonald, Ph.D.

Process Development Unit

The Process Development Unit (PDU, headed by David L. Narum), as a team, develops a series of steps to produce investigational malaria vaccines, biomolecules composed of recombinant, conjugated protein-protein nanoparticles for phase 1 and 2 human clinical trials.  The process initiates with identifying an expression clone using predominately yeast (Pichia pastoris) or bacteria (Escherichia coli) expression platforms.  An expression clone is fermented under controlled conditions in small benchtop bioreactors (0.5 – 5L) to produce a recombinant protein of interest (POI).  The POI is purified following protocols to identify tangential flow filtration and chromatography medias suitable for both positive and negative selection, to yield process steps that provide both high quality and quantity.  Throughout development of step-wise processes for fermentation and purification, analytical assays (developed in parallel) are used to characterize the biochemical and biophysical makeup of the POI.  Once all steps are established at bench scale, the PDU increases to pilot-scale manufacturing using a 60L in-house fermenter; and prepares full documentation (including POI analytics) for technical transfer to a cGMP contract manufacturing organization, which then produces the investigational malaria vaccine for human use.


Select publications:

  1. Singh K, Burkhardt M, Nakuchima S, Herrera R, Muratova O, Gittis AG, Kelnhofer E, Reiter K, Smelkinson M, Veltri D, Swihart BJ, Shimp R Jr, Nguyen V, Zhang B, MacDonald NJ, Duffy PE, Garboczi DN, Narum DL. (2020) Structure and function of a malaria transmission blocking vaccine targeting Pfs230 and Pfs230-Pfs48/45 proteins. Commun. Biol. Jul 24;3(1):395.
  2. Reiter, K., Suzuki, M., Olano, L.R., Narum, D.L. (2019) Host cell protein quantification of an optimized purification method by mass spectrometry.  Journal of Pharmaceutical and Biomedical Analysis, 174, pp. 650-654. 
  3. Burkhardt, M., Reiter, K., Nguyen, V., Suzuki, M., Herrera, R., Duffy, P.E., Shimp, R., MacDonald, N.J., Olano, L.R., Narum, D.L. (2019) Assessment of the impact of manufacturing changes on the physicochemical properties of the recombinant vaccine carrier ExoProtein A.  Vaccine, 37 (38), pp. 5762-5769.
  4. MacDonald, N.J., Nguyen, V., Shimp, R., Reiter, K., Herrera, R., Burkhardt, M., Muratova, O., Kumar, K., Aebig, J., Rausch, K., Lambert, L., Dawson, N., Sattabongkot, J., Ambroggio, X., Duffy, P.E., Wu, Y., Narum, D.L.  (2016) Structural and immunological characterization of recombinant 6-cysteine domains of the Plasmodium falciparum sexual stage protein Pfs230.  J. Biol. Chem. 291: 19913-19922.
  5. Shimp, R.L., Rowe, C., Reiter, K., Chen, B., Nguyen, V., Aebig, J., Rausch, K., Kumar, K., Wu, Y., Jin, A.J., Jones, D.S., Narum, D.L.  (2013) Development of a Pfs25-EPA malaria transmission blocking vaccine as a chemically conjugated nanoparticle.  Vaccine  31:2954-2962.
     

Victor Raul Herrera Espinoza

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Master’s, Marine Microbiology, Nagasaki University, Japan

Bachelor's, Microbiology, Universidad Nacional Agraria La Molina, Peru

Languages Spoken: Spanish, Japanese

Extensive experience in fermentation recovery and protein purification operations, with focus on process development from small to pilot scale production of malarial vaccine products expressed in prokaryotic and eukaryotic platforms, suitable for use in human clinical trials (phase I-II) with subsequent technology transfer of optimized in-house pilot scale protein production operations to external...

Learn more about Victor Raul Herrera Espinoza

Vu Nguyen, M.S.

Research Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Information Technology, University of Maryland

B.S., Chemistry, Virginia Tech

Languages Spoken: Vietnamese

Researching various fermentation expression platforms, such as, Pichia pastoris, E. coli, mammalian cells, insect cells, etc., to maximize quality and quantity of novel malaria proteins. Ultimately, transferring in-house applied research to external contract manufacturing organizations to produce clinical grade cGMP malaria vaccines for human trials.

Learn more about Vu Nguyen, M.S.

Karine Reiter, M.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., John Hopkins University

B.S., George Washington University

Languages Spoken: French

Biologist with extensive experience in protein analysis. I develop assays for the biochemical and biophysical characterization of research and investigational recombinant protein-based malaria vaccine antigens. The assays are also used to evaluate process efficiencies related to product quality and quantity.

Learn more about Karine Reiter, M.S.

Quality Control Unit

The quality control unit (headed by Daming Zhu) sets quality control standards and provides quality control evaluation for preclinical and clinical bulk drug substance, drug products, and formulations of clinical trial materials. The quality control department prepares data packages for IND filings.

Daming Zhu, M.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., China Agricultural University, China

B.S., Jilin University, China

Languages Spoken: Chinese

Daming Zhu is a biochemist by training with many years of research experience relating to immunology and vaccinology and has co-authored more than 40 scientific articles in peer-reviewed journals. She is a recognized expert in quality control of vaccines, particularly with the protein-based vaccines. She led the quality control unit of LMIV and developed numerous quality control methods, including...

Learn more about Daming Zhu, M.S.

Weili Dai, MMed

Research Associate

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Master of Medicine, Xi’an Medical University, China

Bachelor of Medicine, XingJiang Medical University, China

Languages Spoken: Chinese

As an experienced technologist with vaccine quality control, Weili performs routine evaluations of preclinical and clinical vaccines and related materials using various methods and instruments. She also devotes her time preparing QC data and documents.

Learn more about Weili Dai, MMed

Timothy Daniel, B.A.

Postbaccalaureate IRTA

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.A., Chemistry, Harvard

Languages Spoken: Swahili

My research interests involved working towards ways to reduce suffering of disease in third world countries, and the most efficient way to achieve this is a focus on prevention of the disease itself. Currently, I am heavily focused on verifying the viability of varying samples of the malaria vaccine for clinical trials, generally through SDS-Pages and Western Blots.

Learn more about Timothy Daniel, B.A.

Holly McClellan, M.S.

Microbiologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., B.S.

Quality control studies in support of IND applications to the FDA for malaria vaccine candidates put forward by the Laboratory of Malaria Immunology and Vaccinology (LMIV). Transmission Blocking Vaccine / Vaccine to Interrupt Malaria Transmission TBV/VIMT program team coordinator serving as program liaison to the Portfolio Review Team (PRT) for the LMIV.

Learn more about Holly McClellan, M.S.

Recombinant Antigen and Antibody Development Unit

The Recombinant Antigen and Antibody Development Unit (headed by Jonathan P. Renn) has three primary goals. First, we generate novel recombinant proteins for pre-clinical malaria vaccine discovery. These novel proteins are tested in small animal models for improvements in function over current malaria vaccine candidates. Second, we produce human monoclonal antibodies from subjects that have been infected by malaria or received a vaccine. Third, we develop novel assays using our monoclonal antibodies and antigens to interrogate immune responses induced by malaria infection or vaccination. By understanding the host antibody response to malaria infection or vaccination we can improve current vaccines or discover novel vaccine targets.

Jonathan P. Renn, Ph.D.

Scientist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

Ph.D., Biochemistry, University of Notre Dame

Postdoctoral Fellow, Northwestern University

I am a protein biochemist by training and in my current position at LMIV is leading the recombinant antigen and antibody development unit. My research interests include designing and producing novel malaria antigens for preclinical vaccine development, production of human monoclonal antibodies, and development of novel assays to support malaria vaccine development.

Learn more about Jonathan P. Renn, Ph.D.

Martin Burkhardt, B.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.S., Biology, University of Massachusetts North Dartmouth

Uses recombinant DNA technology to produce human antibodies to characterize effectiveness of malaria vaccine antigens. Develops novel applications in mixed mode chromatography to purify malaria vaccine candidates.

Learn more about Martin Burkhardt, B.S.

Matthew Cowles, B.A.

Research Associate

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.A., Biochemistry

Implement and validate liver stage and blood stage antigen multiplex panels to screen clinical samples. Express, refold, and purify liver stage vaccine candidates in E. coli. Help characterize/process proteins/antibodies produced by the group by ELISA and western blot.

Learn more about Matthew Cowles, B.A.

Holly Torano, B.S.

Biologist

Contact: For contact information, search the NIH Enterprise Directory.

Education:

B.S., Biology, John Brown University

Provides molecular biology support for DNA and adenoviral vector Plasmodium vaccine candidates. And performs parasite assays that evaluate functional activity from vaccine studies.

Learn more about Holly Torano, B.S.

Scientific Operations and Management Unit

The Scientific Operations and Management Unit (headed by Richard L. Shimp Jr.) oversees and manages all aspects of LMIV operations including procuring of laboratory and IT equipment, human resources, property, and finances. 

Richard L. Shimp Jr., M.S.

Scientific Operations Manager

Contact: For contact information, search the NIH Enterprise Directory.

Education:

M.S., Biotechnology, Johns Hopkins University

B.S., Biology, West Virginia Wesleyan College

Course Work Only, Animal and Veterinary Sciences, West Virginia University

Responsibilities include AMBIS, HR, Operations, Property, Surplus, IT Equipment, Software, and all aspects of Laboratory Operations. I have experience in fermentation, purification, technology transfer, and cGMP as well as laboratory assays that support these functional areas.

Learn more about Richard L. Shimp Jr., M.S.

Chaketa Ingram

Secretary II

Contact: For contact information, search the NIH Enterprise Directory.

Education:

H.S. Diploma

Languages Spoken: Spanish

Chaketa Ingram serving as a Secretary for LMIV. In this compacity, she processes AMBIS orders collecting data for budget related task, Travel, Property, Surplus, IT Equipment, Software, fermentation-purification technology transfer, cGMP as well as laboratory assays that support these functional areas, and all aspects of Laboratory Operations.

Learn more about Chaketa Ingram

Rhea J. Stevens, MPH

Sample Management Coordinator

Contact: For contact information, search the NIH Enterprise Directory.

Education:

MPH, George Washington University

B.S, George Washington University

I am part of LMIV’s Operations Team. My main responsibilities include receipt and inventory of samples collected during LMIV clinical and animal pre-clinical trials, upkeep of sample management database, training and support to LMIV Freezerworks users and those in partnerships in clinical sites in West Africa, and clinical trial logistics.

Learn more about Rhea J. Stevens, MPH

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