Annandale, VA; September 27, 2022

mRNA Vaccines Have Changed the Way We Fight Infectious Diseases

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."

Annandale, VA; August 16, 2022

Are Vaccines Really Important, Do We Really Need Them?

At CARE-ID they’re really, really important. It’s what we work on studying nearly every day. However, this is also an important question that every responsible, self-sufficient adult may want to prepare themselves to answer.

"Our viral infections experiences since March of 2020 have for nearly everyone been simply, “overwhelming”. SARS-Cov-2 (COVID-19) hit us out of nowhere and frightened many all the way back to the experiences of the 1918 “Spanish Flu” pandemic. Most didn’t know how bad 1918 to 1920 was but learned rather quickly . Less apocalyptic viruses preceded COVID such as: SARS, Zika, and Chikungunya outbreaks, but weren’t widespread. Nevertheless, these were early warnings that the expanse of infectious diseases has grown to be more challenging than ever before. Now another new warning has emerged in monkeypox. And “wait for it”, another new one was just announced by researchers, the novel Langya henipavirus (LayV) . One might ask is there an end in sight or is this a “new normal”? And can we find our way out of this safely?

Annandale, VA; June 1, 2022

Older Adults Need to Combat RSV (Respiratory Syncytial Virus) Too!

The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are continuing their efforts on the vaccine development front in the area of another respiratory virus commonly associated with children but which is also a danger to many older adults. Working with Bavarian Nordic for the very first time, CARE-ID is beginning a Phase III trial of the recombinant MVA-BN® RSV vaccine in adults aged 60 years and older. The primary objective of the study is to assess the efficacy of the vaccine candidate in lower-respiratory tract disease caused by RSV compared to placebo.

"Most of our attention over the past 2 years has been on the COVID-19 virus. But it’s not the only respiratory virus we need to be concerned about," said David Wheeler, MD, FACP, FIDSA, principal study investigator, managing partner of Infectious Diseases Physicians, Inc. (IDP), the private clinical practice partner of CARE-ID. "Just as we have developed vaccine protections against COVID and influenza, we have an opportunity to do the same for RSV. Most people who get an RSV infection will have mild illness and will recover in a week or two. Some people, however, are more likely to develop severe RSV infection and may need to be hospitalized. RSV can also make chronic health problems worse. For example, people with asthma may experience asthma attacks as a result of RSV infection, and people with congestive heart failure may experience more severe symptoms triggered by RSV."

Annandale, VA; May 31, 2022

The COVID-19 Battle Continues with the Development of a New Preventive

The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are very pleased to announce their collaboration with Astra Zeneca for a new clinical trial (ENDURE) of its combination product of 2 monoclonal antibodies for pre-exposure prophylaxis (prevention) of COVID-19. The study will be a Phase II, randomized, open-label, multicenter, dose-ranging study.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, has reported: "Recent data from its Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six-month follow-up analysis, compared to placebo."

Annandale, VA; March 10, 2022

An important clinical study for people with recurrent Clostridium difficile (c Diff) infection

The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are very pleased to announce their collaboration with Ferring Pharmaceuticals Inc. for a pivotal, new research study addressing recurrent Clostridium difficile infection (C. diff or CDI). This study will involve treating these infections with a novel fecal transplant compound, RBX2660, an enema-based material derived from healthy stool donors.

“A new investigational Microbiota Restoration Therapy (MRT™), the RBX2660 formulation (a microbiota-based live biotherapeutic), will be the foundation for this study”, stated Executive Director, Steve Poretz. “Fecal transplantation isn’t a new technique. But the approach and formulation Ferring and Rebiotix are using is a somewhat unique approach. Because C. diff is a very difficult condition to treat, we are anticipating this novel therapy will produce greater participation among the community of C. diff patients. For this study there will not be a placebo meaning all participates will receive the actual treatment therapy”

Annandale, VA; February 22, 2022

COVID-19 Vaccine Clinical Trial Update

The leaders of the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) continue to express their extreme gratitude to its volunteer participants in the Pfizer COVID-19 vaccine and booster clinical trials. The delivery of these vaccines has substantially reduced new infections and created a pathway back to more normal lives.

“To ensure our study participants and their loved ones have the best information possible that CARE-ID can provide, we base all that we do on the science, vaccine experts, and FDA guidance and approvals, in addition to the appropriate CDC recommendations”, stated Executive Director, Steve Poretz. “Guided by these principles, we provide our Pfizer vaccine clinical trial participants updated information on the status of our on-going trials as well as information on new trials that Pfizer is considering. What we can share today is an update on an upcoming booster trial and a source for vaccine trial participants to explore and to discover additional valuable information and resources that may be useful.”

Annandale, VA; August 23, 2021

COVID-19 Vaccine Booster Shots and Booster Clinical Trial Update

The leaders and researchers at the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) are closely following media reports concerning booster shots. They appreciate how much information is coming out and also recognize how confusing it can be at times.

“To ensure our study participants and their loved ones have the best information possible that CARE-ID can provide, we base all that we do on the science, vaccine experts, and FDA guidance and approvals, in addition to the appropriate CDC recommendations”, stated Executive Director, Steve Poretz. “Guided by these principles, we are providing our clinical trial participants the information we currently have available on the status of our upcoming booster shots for the original clinical trial that began last August.”

Annandale, VA; June 23, 2021

Fight Against COVID-19 Continues with a New Clinical Trial

The leaders of the Clinical Alliance for Research and Education-Infectious Diseases (CARE-ID) would like to express their extreme gratitude to its volunteer participants in the Pfizer COVID-19 vaccine clinical trial. These volunteers’ contributions of time and consistent attention to detailed follow-ups helped lead to the Emergency Use Authorization (EUA) for one of the three COVID-19 vaccines in record time. The delivery of these vaccines has, in turn, substantially reduced new infections and created a pathway back to more normal lives.

“Our Pfizer vaccine study participants have and continue to assist in creating essential data on the durability and length of antibody protection post-vaccination. This effort is vital to adding to the understanding of how the virus and the vaccine behave over longer periods of time”, stated Executive Director, Steve Poretz. “To this end, we can begin to look at using this data to set out on a new Pfizer vaccine clinical trial to evaluate whether a booster (3rd dose) will be needed.”

Study participants who initially received the active vaccine (not the placebo) will be invited to enroll in the upcoming booster study. This will be conducted on a smaller scale with limits on how many participants can enroll.

Annandale, VA; January 6, 2021

Update in the Fight Against COVID-19

On December 11, 2020 the FDA gave its official EUA (Emergency Use Authorization) for the Pfizer COVID-19 vaccine.

It is important to keep in mind the fight doesn’t end with the EUA. Months of ongoing monitoring and study of volunteers’ medical status is essential to understanding the full range of effectiveness for the vaccine. This on-going nature is a normal part of virtually every clinical research study.

Very recently, On December 31, 2020, a senior director in Pfizer’s vaccine clinical research and development group announced, "We recognize that our clinical trial participants are selfless volunteers who have made the important choice to make a difference and fight this pandemic. While the study continues to be blinded to answer important public health questions…we are committed to ensuring that our trial participants are recognized for their contributions and that placebo recipients who wish can receive BNT162b2 within the study.”

Annandale, VA; October 31, 2020

Pfizer CEO Thanks Clinical Alliance for Research and Education – Infectious Diseases (CARE-ID) for Vaccine Study Partnership

As CARE-ID has reached its key milestone of allocated enrollees in this collaboration, the Pfizer CEO expressed his appreciation directly to the principal investigator and his team.

“On behalf of Pfizer and our leadership, I would like to personally thank you and your team[s] for your exceptional partnership over the last several months. This year has been unlike any we have ever experienced, as the COVID-19 pandemic continues to place great medical, social and economic burdens on the world. Whether you are in the United States [or other countries around the globe], we are all united in our commitment to determining whether we have a safe and effective vaccine candidate that can protect our communities from COVID-19 infection. Each of you has played an indispensable and extraordinary role in our quest to conquer this disease, and for that, we are profoundly grateful…”

Annandale, VA; October 5, 2020

The Clinical Alliance for Research and Education (CARE-ID) Continues the Blaze-1 COVID-19 Clinical Trial.

CARE-ID announced it is continuing the clinical research study to evaluate the safety and effectiveness of LY-CoV555 in patients with early mild to moderate COVID-19. Sponsored by Eli Lilly and Company (Lilly), the BLAZE-1 Study is looking for adults ages 18 or older who have recently tested positive for COVID-19 and are not hospitalized. Several weeks ago, CARE-ID reached is target enrollment and re-directed it resources to the Pfizer vaccine study. Due to the nature of the 2 studies (one treatment and the other vaccine) it was critically important to maintain strict separation of the two study populations. Pfizer, however, within the past week has moved to re-allocate volunteer slots to geographies with higher infection rates in the general population. This pause in the vaccine study for CARE-ID makes it possible to reenergize its focus on the antibodies study.

Annandale, VA; September 17, 2020

The Clinical Alliance for Research and Education – Infectious Diseases (CARE-ID) Opens a New Arm of Vaccine Study

CARE-ID has reached its allocated target for enrollees in its collaboration with Pfizer for clinical research to evaluate the safety and effectiveness of its SARS-CoV-2-RNA vaccine candidate against COVID-19. This is a major CARE-ID milestone in the collaboration and initially this target was thought to be the end goal of its research effort. However, Pfizer has now expanded the original study. The expansion will allow the further increase in trial population diversity, and inclusion of people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data. In this expansion, Pfizer gains a particularly valuable partner given CARE-ID decades long experience in researching treatments for these particular infectious diseases.

USA Today – September 6, 2020 By Elizabeth Weise

We don’t know when a COVID-19 vaccine will arrive, but we’re starting to know how it will be distributed.

Interviews with logistics experts, immunization professionals and pharmaceutical distribution specialists, together with U.S. Centers for Disease Control and Prevention planning documents, give a clearer picture of how coronavirus vaccines will get from manufacturers into the arms of millions of Americans.

“The swift and so far positive effort to create vaccines to fight COVID-19 has been remarkable, but it’s only half of the work”, said Tinglong Dai, a professor of operations management who studies health care analytics at the Johns Hopkins University.

“It’s just incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains ever built,” he said.

Annandale, VA; September 1, 2020

The Clinical Alliance for Research and Education – Infectious Diseases (CARE-ID) Marks Its First Month in Expanding the Science for Effective COVID-19 Treatments

Beginning in the months of July and August this year, CARE-ID committed its research experience and resources to the fight against COVID-19. In doing so, it not only continues its role in advancing medicines for a variety of infectious diseases, now it is a notable participant in expanding the science for effective COVID-19 treatments. The first step came in partnering with Lilly and Company (Lilly) to conduct a clinical research study, BLAZE-1, to evaluate the safety and effectiveness of LY-CoV555 (an antibody therapy) in patients with early mild to moderate COVID-19. The promise of this drug is to help newly diagnosed patients clear the SARS-CoV-2 virus faster. The second, very quick, step was continuing the longstanding collaboration in place with Pfizer. In this case it was to conduct clinical research to evaluate the safety and effectiveness of its SARS-CoV-2-RNA vaccine candidate against COVID-19. The promise of a vaccine against COVID-19 is nearly impossible to overestimate in today’s fight against this pandemic disease.

Annandale, VA; August 24, 2020

The Clinical Alliance for Research and Education (CARE-ID) Begins Recruiting Adults for COVID-19 Investigation Vaccine Clinical Trial

CARE-ID announced today it has begun recruiting volunteers in a clinical research study to evaluate the safety and effectiveness of a vaccine candidate against COVID-19. Sponsored by Pfizer, the C4591001 (NCT04368728) is a phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-COV-2-RNA vaccine candidates against COVID-19 in health adults.

Annandale, VA; August 17, 2020

The Clinical Alliance for Research and Education (CARE-ID) Reaches 50% Enrollment for the Blaze-1 COVID-19 Clinical Trial

CARE-ID is very pleased to report it has reached 50% of its target for participants receiving their treatment infusions. “We were not entirely sure how strong a response we’d get when we began. Starting up this study was very fast compared to other studies we’ve done in the past,” said Steve Poretz, RN, MSHA, Executive Director at CARE-ID. “Happily, the response has been very good so far for this very important clinical research study.” Sponsored by Eli Lilly and Company (Lilly), the BLAZE-1 Study is evaluating a potential COVID-19 antibody treatment following successful results in the laboratory setting. As of August 14th, hundreds of participants have enrolled in the study nation-wide and have received the one-time, one-hour infusion in the outpatient setting. To continue making its progress, CARE-ID is looking for additional adults in the Northern Virginia area ages 18 or older to participate in the study who have recently tested positive for COVID-19 and are not hospitalized.

Annandale, VA; August 5, 2020

The Clinical Alliance for Research and Education (CARE-ID) Records Its First Enrollees and Infusions for the Blaze-1 COVID-19 Clinical Trial

CARE-ID has made very good progress toward its total enrollment goal with 20% achieved to date. With these initial participants already signed up and receiving their first infusions, CARE-ID is off to a good start for this landmark clinical research study. Sponsored by Eli Lilly and Company (Lilly), the BLAZE-1 Study is evaluating a potential COVID-19 antibody treatment following successful results in the laboratory setting. As of August 3rd, over 200 participants have enrolled in the study nation-wide and have received the one-time, one-hour infusion in the outpatient setting. To continue making its progress, CARE-ID is looking for additional adults in the Northern Virginia area ages 18 or older to participate in the study who have recently tested positive for COVID-19 and are not hospitalized.

Science Magazine – August 4, 2020 By Jon Cohen

Designer antibodies could battle COVID-19 before vaccines arrive

Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

While the world is transfixed by the high-stakes race to develop a COVID-19 vaccine, an equally crucial competition is heating up to produce targeted antibodies that could provide an instant immunity boost against the virus. Clinical trials of these monoclonal antibodies, which could both prevent and treat the disease, are already underway and could produce signs of efficacy in the next few months, perhaps ahead of vaccine trials.

Annandale, VA; June 29, 2020

The Clinical Alliance for Research and Education (CARE-ID) Begins Recruiting Adults Who Recently Tested Positive for COVID-19 for Clinical Trial

CARE-ID has begun recruiting and treating patients in a clinical research study to evaluate the safety and effectiveness of LY-CoV555 in patients with early mild to moderate COVID-19. Sponsored by Eli Lilly and Company (Lilly), the BLAZE-1 Study is evaluating a potential COVID-19 antibody treatment following successful laboratory studies. CARE-ID is looking for adults ages 18 or older to participate in this study who have recently tested positive for COVID-19 and are not hospitalized.