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Annandale, VA; July 21, 2023

The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are pleased to address our first clinical trial collaboration with Johnson and Johnson. The Janssen Pharmaceutical Companies of Johnson & Johnson is a global leader in medicines development, and it is taking a major step in fighting a very serious infectious disease, Invasive Extraintestinal Pathogenic Escherichia Coli (ExPEC) Disease (IED).

Mention of E. coli (Escherichia coli) often brings to mind foodborne illnesses. Most types of E. coli are harmless or cause relatively brief diarrhea. A few particular types can cause more severe stomach cramps, serious diarrhea and vomiting. But there is an even more serious type of E. coli that concerns infectious diseases specialist.

“Bacteremia and sepsis caused by ExPEC bacteria are among the top 10 causes of death in older adults, and the number of cases is rising as the population ages,” says Jan Poolman, Ph.D., Head of Bacterial Vaccines Discovery and Early Development and Disease Area Stronghold Leader Bacterial Vaccines at the Janssen Pharmaceutical Companies of Johnson & Johnson. “At Janssen, we want to help people live longer, healthier lives and enjoy their grandchildren for years to come. Our fight to tackle and limit the burden of ExPEC is one of the ways we hope to realize this vision.”

ExPEC disease is defined as an acute illness consistent with an invasive bacterial infection. The disease is confirmed by the identification of E. coli from blood, or from urine in a patient with urosepsis and no other identifiable source of infection.

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Annandale, VA; June 26, 2023

Gilead Sciences, Inc. has been a global leader in developing HIV/AIDS therapies for over 3 decades. The leaders and researchers of the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are proud to have collaborated with Gilead over the years for many of its developments. We are now partnering with Gilead again in pursuing what could be a truly monumental innovation in HIV treatment. This new clinical trial has just gotten started, and we are extremely excited to welcome our first study participants into the screening process.

Optimizing outcomes and reducing the laborious regimens of care for people living with HIV has been a goal for as long as HIV therapies have been offered. One key to achieving this goal has been developing longer acting options for patients. Lenacapavir (LEN) is a Gilead innovation with the potential to be a preferred and versatile foundational long-acting agent due to its therapeutic potency and a range of dosing frequencies and administration options.

Gilead HIV Clinical Development vice-president Jared Baeten said, “We’re excited to share promising Phase Ib clinical trial results that reinforce lenacapavir’s potential to be a foundational agent for long-acting combination HIV treatment options, and we are especially pleased to see the potential of the combination of lenacapavir plus bNAbs dosed once every six months. We are committed to exploring novel therapy approaches that may help deliver care for all people living with HIV, with a focus on developing person-centric options that fit into the diverse lives of people living with the virus, as we continue in our pursuit of ending the HIV epidemic for everyone, everywhere.”

CARE-ID yearslong focus on HIV research will take another step forward with this new clinical trial.

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Annandale, VA; June 9, 2023

The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are pleased to announce a refocusing of their collaboration with Astra Zeneca for an advanced monoclonal antibody for pre-exposure prophylaxis (prevention) of COVID-19.

Not everyone can take advantage of COVID-19 vaccines.  In particular, people whose immune systems are compromised by genetic conditions and other illnesses have difficulty generating a strong enough immune response after receiving the available vaccines. Without such a response, the vaccines aren’t as effective at preventing a COVID-19 infection and severe sickness.

For this reason, there is an effort underway to develop a COVID-19 preventive antibody agent that can provide protection. AstraZeneca, a major pharmaceutical company, has been working on this new type of agent andCARE-ID is an active partner in this effort.

“Antibody treatment is different from a vaccine”, says Stephen Poretz, RN, MSHA, MBA, CARE-ID Chief Operating Officer.  “Pre-exposure prophylaxis (PrEP) agents like monoclonal antibodies behave like naturally occurring antibodies while vaccines behave like a pathogen trying to stimulate one’s own antibody production.  This type of preventative (a “pre-exposure prophylaxis”) can’t come fast enough for some people.”

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Annandale, VA; December 17, 2022 The leaders and researchers at Ferring Pharmaceuticals Inc. announced earlier this month Food and Drug Administration (FDA) approval of its microbiota-based therapy for a type of debilitating intestinal infection making it the first drug of its kind for U.S. market. This is also an exciting announcement for the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) because of its role as a clinical research site earlier in 2022. The treatment, called Reybota, is cleared for use in adults 18 and older who have recurrent infections of Clostridioides difficile, or C. diff, and have completed a round of antibiotics. Epidemiological studies indicate that C. diff has become the most common microbial cause of healthcare-associated infections in U.S. hospitals and costs up to $4.8 billion each year in excess health care costs for acute care facilities alone. “It isn’t often that we see such positive results and so quickly in the research process, stated CARE-ID Medical Director, David Wheeler, MD, FACP, FIDSA. “CARE-ID received its approval to begin recruiting and enrolling participants in March of this year and the process began immediately. In this case, the FDA’s recognition of the importance of this treatment makes us that much more gratified that we were able to participate in this study.

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Annandale, VA; September 27, 2022 The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are pleased to announce their continuing efforts in the vaccine development area. Messenger ribonucleic acid (mRNA) biotechnology, used to develop several COVID-19 vaccines, is beginning to open the way for rapid development of other important vaccines. CARE-ID will again be working with one its most prominent partners, Pfizer, by participating in the clinical study for its modRNA-based influenza (Flu) vaccine [modified RNA]. The primary objective of the study is to determine if the vaccine candidate is safe and helps the body produce antibodies that fight off the flu virus. "Much of our attention over the past 2 years has focused on the COVID-19 virus. Now that most of our communities around the United States have been able to manage through the unprecedented nature of the COVID threat, we must now return to fighting more common viral threats like flu,” said Donald Poretz, MD, FACP, FIDSA, principal study investigator. “The supporting science and the real-world results of mRNA-based vaccines suggest this approach can be highly effective at activating an individual’s immune system. This could be an important breakthrough since an mRNA flu vaccine wouldn’t contain weakened or dead flu virus permitting more rapid development and higher volume production of flu vaccines."

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