Please note: This trial has finished recruiting and is not accepting new participants.

Research Center: Gwinnett Research Institute
Location: 2805 Hamilton Mill Rd #4110, Buford, GA 30519, United States
Lead Researcher: Alexander Osowa, M.D.
IRB Committee: This study has been reviewed and approved by the Advarra Institutional Review Board

Did you know that RSV is the leading cause of severe lung infections in older adults? RSV or the Respiratory Syncytial Virus affects the air passages of the lungs. It is highly contagious and can affect anyone. In some cases, it can look like a common cold. However, RSV can cause more serious lung problems like Pneumonia (lung infection) and Respiratory failure (when the blood cannot get enough oxygen from the lungs). Mostly, older adults are at a higher risk of catching this virus. The problem is that there is no current approved RSV vaccine.

RSV infections are common in countries with temperate climates during winter. This is the same time as the flu season. People may not know when they are infected with RSV because the symptoms are very similar to the common cold or flu. RSV and flu are different viruses. This means you can still get an RSV infection even if you have been vaccinated against the flu. This is why researchers at Gwinnett Research Institute are doing a research study to learn more about a potential vaccine that may prevent people from potentially getting RSV. The vaccine being tested in this study was made to prevent infection from the Respiratory Syncytial Virus (RSV). Through this study, more people may receive preventative care from RSV in the future.

Want to get this potential vaccine at no cost? See if you qualify for this study!

• Participants may receive potential preventative care for RSV at no cost. This means you may get potential protection from the virus.
• Participants will be contributing valuable information that may benefit those with RSV, especially older adults, in the future.
• Participants will be compensated up to $100 per study visit and $50 per phone visit for participating in this study. Compensation will only be provided to eligible participants.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Men and women aged 60 years old or older
• Must be either living in a general community, nursing home or assisted living 
• Must be able to move around with minimal assistance. This means being primarily responsible for their self-care and going about daily activities
• Must not be vaccinated with an RSV vaccine 
• Must not be allergic to latex, medications or vaccines
• Must not have had a vaccine in the past 30 days or plan to get one in the future (this does not apply to the COVID-19 vaccine and the flu vaccine)
• Must be able to attend 2 study visits at the research site over approximately 6 months

The study team will explain the research study in its entirety but some details are:

• Participation in this study involves potentially receiving the investigational preventative vaccine as an injection in the upper arm
• Participation in this study involves answering questionnaires, phone calls, emails and text messages from the study team
• Participation in this study involves completing diary entries. 
• The sponsor of this study is GlaxoSmithKline Biologicals SA (GSK). They are developing an RSV vaccine to protect older adults from RSV infection.
• Before a new vaccine can be marketed and given to many people, it needs to be tested and then approved by national health agencies. Several studies are done to test the vaccine. National health agencies look at the results of these studies and approve the vaccine only if it is safe and effective. All vaccines that you receive have been through this same process. This study may also help us learn more about RSV and the effects of the RSV study vaccine. By taking part, you may help make new vaccine(s) to protect people against RSV. 

Gwinnett Research Institute

Gwinnett Research Institute is an experienced, multi-specialty research site accomplished in Phase II-IV studies that comes with a combined 10-plus years of research experience. Our Physician and Nurse Practitioners are board-certified in their respective fields and perfectly blend their medical knowledge and training with their clinical expertise. Our entire research team maintains certifications in Good Clinical Practice (GCP) and we always put patient safety and health first.   GRI has research experience in various indications including, but not limited to, Psychiatry, Endocrinology, Women’s Health, Pulmonology and Gastroenterology studies in both pediatric and adult patients. 

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.