Great Lakes Clinical Trials' PBMC Laboratory

Great Lakes Clinical Trials is pleased to announce the recent expansion of its peripheral blood mononuclear cells (PBMC) laboratory. Located on the north-side of Chicago, Great Lakes Clinical Trials’ PBMC lab is private, independent and truly full-service.

“Over the past 2 years, the Great Lakes Clinical Trials team has collected and isolated thousands of PBMC samples,” commented Steve Satek, President snd CEO. “We recently made a significant investment to expand our services to include PBMC cell counting and long-term Liquid Nitrogen storage.”

Human peripheral blood mononuclear cells (PBMCs) are key components of the body’s complex and dynamic immune system. A mononuclear cell is characterized by a single round nucleus and includes lymphocytes, monocytes, and dendritic cells. These cells have important immunological roles defending the body from infection, cancer, and other foreign invaders, making them ideal specimens to study immunological responses.

This full-service offering of Great Lakes Clinical Trials’ PBMC lab is a perfect, seamless supplement to the clinical trial programs being conducted at the various Great Lakes Clinical Trials clinics, particularly in regard to our numerous vaccine clinical trials. “Clinical trial sponsors can now come to Great Lakes Clinical Trials, not only to run the medical aspect of their vaccine studies,” added Satek, “but they can have the same facility process, count and store PBMC samples for future analysis. This creates a seamless service offering in an independent, private setting that is unique to the Chicago area.”

Note that Great Lakes Clinical Trials’ PBMC lab in Chicago is also able to serve as an external, local laboratory for processing of samples collected from other research clinics in the Chicagoland region.

For more information on Great Lakes Clinical Trials PBMC lab and to learn how to contact our team directly, please visit our PBMC webpage by clicking the button below:

Great Lakes Clinical Trials Begins an RSV Vaccine Study

Great Lakes Clinical Trials is pleased to announce that we will soon be enrolling study participants on a new RSV Vaccine clinical trial in older adults, sponsored by Pfizer. Below is an excerpt from the recent Pfizer Press Release:

Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)

Thursday, September 02, 2021 - 06:45am

• First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older

• RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced the initiation of RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.

“RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. “The start of this Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.”

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. The primary objectives of the study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.

RSV is a seasonal illness that commonly starts in the fall months, peaking in the winter when colds and other respiratory illnesses are more common.1

Burden of RSV

Respiratory syncytial virus (RSV) is a common and pervasive cause of acute respiratory illness.2,3 The virus is highly contagious and affects the lungs and airways. 4,5 Infections occur in people of all ages and can feel like the common cold for most young adults, but for infants, the immunocompromised, and older adults, it can be potentially life-threatening.3

The risk of serious infection increases in older adults and for those with chronic heart or lung disease or a weakened immune system.2 In the U.S., it is estimated that more than 177,000 older adults ≥65 years of age are hospitalized and 14,000 of them die each year due to RSV. 2,6 There is no vaccine to prevent RSV and the medical community is limited to offering only supportive care for those with the illness.

About RSVpreF

Pfizer’s investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of a key form of a viral protein that RSV uses to attack human cells. The NIH research showed that the antibodies that protect humans from RSV target this one form of the viral protein. Applying insights from this important work, Pfizer developed and tested numerous candidates and identified those that elicited a strong anti-viral immune response in pre-clinical evaluation, which led to the vaccine candidate that Pfizer is evaluating in human trials.

The full press release can be viewed here: FULL PRESS RELEASE

If you are interested in learning more and being contacted about participating on this upcoming clinical trial, visit our RSV Study Webpage to sign up!

Respiratory Syncytial Virus (RSV): A Hidden Annual Epidemic

Key Facts

• Globally, RSV affects an estimated 64 million people and causes 160,000 deaths each year.

• RSV is a common virus that causes cold-like symptoms in children and older adults.

• The peak season for RSV infection in the United States is fall through spring.

• The elderly and adults with chronic conditions or weakened immune systems are at high risk for developing severe RSV.

• People do not form long-lasting immunity to RSV and can become infected repeatedly over their lifetime.

Click on image to view a full Infographic from the National Foundation for Infectious Diseases

What Causes RSV?

RSV is spread from person to person through close contact with someone who is infected via secretions from coughing and sneezing or touching objects such as toys or doorknobs that have the virus on them.

It takes between two and eight days from the time of exposure for someone to become ill. The illness normally lasts three to seven days, and it is during this time that those infected are most contagious.

What Are the Symptoms of RSV?

Initial signs of RSV are similar to mild cold symptoms, including congestion, runny nose, fever, cough, and sore throat. Very young infants may be irritable, fatigued and have breathing difficulties. Normally these symptoms will clear up on their own in a few days.

A barking or wheezing cough can be one of the first signs of a more serious illness. In these instances, the virus has spread to the lower respiratory tract, causing inflammation of the small airways entering the lungs. This can lead to pneumonia or bronchitis.

How RSV Is Diagnosed

Because mild RSV symptoms are similar to the common cold, testing usually isn't required to diagnose the infection. However, your doctor may suspect RSV based on your medical history, time of year and a physical exam. In this case, they may want to run lab tests to confirm the diagnosis. The most common is a mouth swab or a blood test to check white blood cell counts and look for viruses.

Because mild RSV symptoms are similar to the common cold, testing usually isn't required to diagnose the infection. However, your doctor may suspect RSV based on your medical history, time of year and a physical exam. In this case, they may want to run lab tests to confirm the diagnosis. The most common is a mouth swab or a blood test to check white blood cell counts and look for viruses.

How RSV Is Treated

Mild RSV infections will go away in a week or two without treatment. You can use over-the-counter fever reducers and pain relievers to manage your symptoms. Check with your doctor if you are not sure if an over-the-counter product is safe to give to your child. Your doctor may also suggest nasal saline drops or suctioning to clear a stuffy nose. Supportive care such as staying hydrated and comfortable is also helpful.

RSV Prevention 

RSV is highly contagious. So, there are some steps you should take to prevent its spread. The most effective means of protection are some of the simplest, such as:

• Avoiding close contact with infected people

• Avoiding sharing cups, bottles or toys that may have been contaminated with the virus since the virus can live on surfaces for several hours

• Thoroughly washing hands with soap and water after coming into contact with an infected person

Research

Researchers are working to develop a vaccine, but currently, there is nothing available for public use. In collaboration with Pfizer, Great Lakes Clinical Trials will soon be initiating a clinical trial for an RSV vaccine. The expected start date is early October 2021. If you are interested in learning more and being contacted about this upcoming study, visit our RSV Study Webpage to sign up!

Note: Information above provided by the American Lung Association (lung.org)