IDCRC Investigator Profile: Wilbur H. Chen, MD

Wilbur H. Chen, MD, is an adult infectious disease physician-scientist with a specific interest in developing vaccines. Dr. Chen is an active investigator within the University of Maryland's Vaccine and Treatment Evaluation Unit (VTEU), and he currently serves as the protocol chair of a Phase 3 study of a pentavalent meningococcal conjugate vaccine (MenFive).
Dr. Chen's research is concentrated on two broad areas of global health. First, he is devoted to developing vaccines for enteric pathogens, infectious diseases chiefly of resource poor and economically disadvantaged countries and populations. Second, he is interested in improved vaccines for the elderly, a rapidly growing segment of the global population which is susceptible to many infections and a special population that generally responds poorly to vaccination.
How long have you worked with a VTEU?
I first became involved with the VTEUs in 2004, during my NIH T32 vaccinology post-doctoral fellowship which followed after my clinical infectious disease fellowship. After I completed my vaccinology fellowship in 2006, I stayed on as a faculty member at the Center for Vaccine Development and Global Health, University of Maryland School of Medicine. I’ve never regretted being involved with the VTEU network and its fabulous scientific members.
Can you share more about the current IDCRC study you're working on?
I am currently the protocol chair of a Phase 3 study of a pentavalent meningococcal conjugate vaccine (now called MenFive), which is being evaluated in Malian infants within their EPI schedule (Expanded Program on Immunization, the routine childhood vaccination schedule). This study has several notable details.
- First, this vaccine represents the next stage to the success which has been demonstrated with MenAfriVac, monovalent serogroup A meningococcal conjugate vaccine, having been introduced into the African Meningitis Belt since 2010. The five selected serogroups are designed to target all the relevant meningococcal serogroups causing invasive disease in the African Meningitis Belt.
- Second, I was the PI of the first-in-human Phase 1 study of this vaccine in 2015, so I am pleased to continue to be involved in the clinical development of this vital vaccine.
- Third, I have been working with colleagues at our sister site in Mali (CVD-Mali) for the past decade, so it is so satisfying to be able to bring a VTEU project to West Africa, where we can not only continue to address important global health issues but through this research we are able to continue to train Malian scientists to perform clinical research.
- Lastly, this study addressed the final conditions which were necessary to gain licensure, World Health Organization (WHO) Recommendations, WHO Pre-Qualification (PQ), and GAVI approval. We began first enrollment of the first participant in March 2022 and were able to build in interim analyses such that a critical first report could be submitted to WHO in August 2023. WHO Strategic Advisory Group of Experts on Immunization (SAGE) made their recommendations for MenFive in September 2023, GAVI allocated resources for MenFive rollout in December 2023, and WHO PQ was extended to down to infants nine months of age and older (based on our study) in February 2024. We are publishing this study in The Lancet, having just obtained editorial approval in this month (January 2025). And, we will be completing the last participant’s last visit in March of this year, so a second publication of the two-year durability of the immune responses is intended.
Briefly describe the IDCRC-supported trials you've worked on.
The IDCRC-trials I have supported are notable in that I have not been involved in any of the SARS-CoV2 vaccine studies. Most of my research agenda is focused on enteric infections, preventing the human pathogens of the gut. One of the IDCRC-trials is one that is moving from concept phase and into protocol development—it is a Phase 1 first-in-human evaluation of an orally ingested yeast (Saccharomyces boulardii, commonly available as nutritional supplements) which has been genetically engineered to express VHH antibody targeting Toxins A and B of Clostridiodes difficile, a highly contagious cause of diarrhea and colitis. Another IDCRC-trial is a partnership with Dr. Robert Frenck at Cincinnati Children's Hospital Medical Center VTEU on a Phase 2 efficacy evaluation of a parenteral vaccine targeting ETEC, one of the most common causes of traveler’s diarrhea and an important agent causing moderate-severe diarrhea in young children of developing countries—this study will involve human experimental challenges with a wild-type ETEC.
Learn more about IDCRC-support studies.
What is a strength or example of the importance of the IDCRC?
The IDCRC’s importance is that the network of scientists across the multiple institutions are able to collectively tackle critical public health problems as they arise. In 2004, there were only two FDA approved manufacturers of influenza vaccines and that year one of the manufacturers experienced a contamination issue in their facility, limiting that season’s influenza vaccine supply. The VTEUs quickly conducted the licensure studies that were necessary to approve another influenza vaccine manufacturer to reduce the risk of future national supply issues. Meanwhile, in late 2003, there was the re-emergence of HPAI A/H5N1 influenza viruses associated with the first human cases with fatalities. Soon thereafter, the VTEUs quickly conducted the studies for the H5N1 vaccines which are now part of the U.S. Pre-Pandemic Influenza Vaccine Stockpile, managed by Biomedical Advanced Research and Development Authority (BARDA). Early in 2009, when the pandemic H1N1 virus emerged, the VTEUs quickly conducted the national pandemic vaccine studies, which were critical for the rollout of the national vaccination campaigns. Therefore, it should be no surprise that the IDCRC was a key partner in the response to the SARS-CoV-2 pandemic.
What do you like to do outside of the VTEU?
Outside of the VTEU, I continue to passionately tackle global health issues through my other enteric research projects. I have an NIH U01 grant to evaluate a prototype combination Shigella-ETEC vaccine candidate, an NIH R01 grant to continue to develop the other components of the combination Shigella-ETEC vaccine, and an NIH U01 grant to evaluate a bacteriophage-based therapeutic candidate that targets Shigella. I also have Gates Foundation funding for the evaluation of an ETEC therapeutic and Wellcome Trust funding for the development of a non-Typhoidal Salmonella (NTS) vaccine.
I am the PI of the Clinical Core of two separate NIH U19 grants, one is part of the Cooperative Centers on Human Immunology (CCHI) and the other is focused on influenza transmission. I am also interested in nurturing the next generation of academic scientists. So aside from my research programs, I am the co-director of the Institute for Clinical and Translational Research’s K12 Program. I am involved in the mentoring and training of junior faculty across three of our system universities, the University of Maryland, Baltimore (where the Schools of Medicine, Dentistry, Law, Nursing, Social Work, Pharmacy, and the Graduate School are located); the University of Maryland, College Park (the flagship undergraduate campus); and the University of Maryland, Baltimore County.
When I am not working, I enjoy cooking and playing tennis with my family.