Javara Contributes to RSV Prevention Vaccine Trial in Collaboration with Privia Health and Moderna

Rhea-AI Summary

On February 14, 2022, Javara announced a clinical trial for an investigational vaccine, mRNA-1345, aimed at preventing respiratory syncytial virus (RSV) in adults aged 60 and older. This trial, conducted in partnership with Privia Health and Moderna (Nasdaq: MRNA), will enroll approximately 34,000 participants across Fayetteville, Annapolis, and Fort Worth. RSV causes significant health issues, with over 177,000 hospitalizations yearly among older adults in the U.S. The trial aims to evaluate the vaccine's safety and efficacy, addressing the urgent need for preventive measures against RSV.

Positive

• Opportunity for approximately 34,000 participants to access a potentially groundbreaking RSV vaccine trial.
• Partnership with recognized organizations, including Moderna and Privia Health, enhances credibility and resources.

Negative

• None.

WINSTON-SALEM, N.C., Feb. 14, 2022 /PRNewswire/ -- Javara, a leading Integrated Research Organization focused on delivering access to clinical trials at the point of care, today announced an opportunity for adults age 60 or older who live in the Fayetteville, Georgia; Annapolis, Maryland; or Fort Worth, Texas areas to participate in a clinical trial of a new investigational vaccine aimed at protecting them from the respiratory syncytial virus (RSV). This clinical trial is being launched in partnership with certain Privia Health Group (Nasdaq: PRVA) subsidiaries and affiliates.

Many are aware of RSV as a seasonal illness that affects infants but don't realize that the virus also frequently causes severe acute respiratory illness in older adults. Each year in the U.S., more than 177,000 individuals who are age 65 or over are hospitalized due to RSV, and approximately 14,000 of them die from the virus.¹ Furthermore, the treatment of RSV in older adults generates an estimated $3 billion in annual medical costs nationally. Due to these concerns, preventing RSV in older adults is urgently important to public health, yet there is no approved preventive vaccine available.

In the phase 2/3 ConquerRSV clinical trial, the biotechnology company Moderna, Inc. (Nasdaq: MRNA) is evaluating its investigational mRNA-1345 vaccine for safety and efficacy in preventing the symptoms of RSV in older adults. It is hoped that this investigational vaccine will prepare the immune system first to recognize the virus by identifying the presence of RSV glycoprotein F, and then to fight the virus by generating neutralizing antibodies. Because the investigational vaccine does not use a weakened or inactive form of RSV, mRNA-1345 cannot cause RSV infection.

Javara, along with their healthcare partners, is working to ensure communities and patients have access to cutting edge developments while enabling diverse representation that is much needed as part of the scientific evaluation of this investigational vaccine.

"Second only to the flu when it comes to causing significant respiratory illness in adults,³ RSV represents an often unrecognized yet very real and imminent threat to our older population. Being able to vaccinate against this virus could save lives, prevent hospitalizations, and conserve healthcare resources," said Javara's Chief Operating Officer, Michael Clay. "By taking this opportunity to test an investigational vaccine aimed at preventing RSV, older adults may increase the possibility that they will be protected from the discomforts and dangers of this virus. At the same time, by helping to move this research forward, these trial participants will be doing their part to prevent suffering and save lives around the world."

Privia Health's Chief Clinical Officer Keith Fernandez, MD, commented, "We are proud to offer Privia patients the opportunity to participate in this clinical trial. This new vaccine candidate for RSV has significant potential to improve the health of our aging population and decrease unnecessary costs within our health system — two key components of Privia's mission of offering high-quality, low-cost care to patients."

The ConquerRSV trial will enroll approximately 34,000 participants who are in general good health. Participants will receive either mRNA-1345 or a placebo. Those interested in participating can contact any of the following locations:

Georgia:

• Fayetteville: 678-904-6577 or infogeorgia@javararesearch.com

Maryland:

• Annapolis: 443-345-1472 or infomarylandeast@javararesearch.com

Texas:

• Fort Worth: 469-663-5038 or infofortworth@javararesearch.com

References:

1. Older Adults Are at High Risk for Severe RSV Infection. Centers for Disease Control website. https://www.cdc.gov/rsv/factsheet-older-adults.pdf. Published August 2017. Accessed Nov. 3, 2021.
2. mRNA-1345 Respiratory Syncytial Virus (RSV) Vaccine. Precision Vaccinations website. https://www.precisionvaccinations.com/vaccines/mrna-1345-respiratory-syncytial-virus-rsv-vaccine. Updated Dec. 1, 2021. Accessed Dec. 14, 2021.
3. Falsey AR, Walsh EE. Respiratory Syncytial Virus Infection in Elderly Adults. Drugs Aging. 2005;22:577-587.

About Javara
Javara, the leading Integrated Research Organization (IRO), partners with large healthcare organizations to deliver clinical trial access at the point of care through integrated research staff and infrastructure. Our access to broad diverse patient populations through their trusted physician ensures clinical trials are completed with high enrollment and retention for quality data delivery. Javara's centralized resources and standardized operations provide efficiencies for accelerated study start-up and quality outcomes, so fewer obstacles stand in the way of the product approval process. As pioneers of Clinical Research as a Care Option (CRAACO), Javara is transforming healthcare and changing lives by connecting the right patients to the right trials at the right time. For more information, please visit Javararesearch.com.

About Privia Health
Privia Health™ is a national physician enablement company that collaborates with medical groups, health plans, and health systems to optimize physician practices, improve patient experiences, and reward doctors for delivering high-value care in both in-person and virtual settings. Privia partners with more than 3,250 providers in seven states and the District of Columbia, offering care to over three million patients at more than 850 practice locations. The Privia platform is led by top industry talent and exceptional physician leadership, and consists of scalable operations and end-to-end, cloud-based technology that reduces unnecessary healthcare costs, achieves better outcomes, and improves the health of patients and the well-being of providers. For more information, visit priviahealth.com.

Javara Media Contact:
media@javararesearch.com

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SOURCE Javara, Inc.

FAQ

What is the mRNA-1345 vaccine being tested in the clinical trial?

The mRNA-1345 vaccine is an investigational vaccine by Moderna aimed at preventing respiratory syncytial virus (RSV) in older adults.

Where is the clinical trial for the mRNA-1345 vaccine taking place?

The trial is taking place in Fayetteville, Georgia; Annapolis, Maryland; and Fort Worth, Texas.

What age group is eligible for the RSV vaccine clinical trial?

Adults aged 60 and older are eligible to participate in the clinical trial.

How many participants are expected to enroll in the ConquerRSV trial?

The ConquerRSV trial aims to enroll approximately 34,000 participants.

What are the potential health impacts of RSV on older adults?

RSV can cause severe respiratory illness in older adults, leading to over 177,000 hospitalizations and approximately 14,000 deaths yearly in the U.S.