Orlando Immunology Center (OIC) is proud to announce to the Central Florida community that our research center located at 1707 N Mills Avenue, Orlando, 32803 has been selected by the National Institutes of Health (NIH) in collaboration with the HIV Vaccine Trial Network (HVTN) to participate in one of the most promising COVID-19 vaccine studies sponsored by Oxford University and AstraZeneca.
OIC is one of 33 other sites in the country (and the only one in Florida) selected for participants study enrollment starting this summer, along with research sites in other countries. This study aims to evaluate ~30,000 subjects (about half in the US) at high risk for COVID infection, including healthcare workers, to demonstrate the vaccine efficacy in preventing COVID-19.
There are currently over 115 potential COVID-19 preventive vaccine candidates being investigated worldwide by private industry, academic centers, or non-profit organizations, most in early clinical research development. Federal experts have selected the following five companies with COVID-19 vaccine clinical trials that may have the best chances of success: Moderna; Oxford University and AstraZeneca; Johnson & Johnson; Merck; and Pfizer.
There are other potential COVID-19 vaccine candidates in more advanced stages of clinical development, but they are being developed by smaller companies, with limited experience in large-scale vaccine manufacturing, which could affect their end success.
OIC is an infectious Disease practice specializing in the treatment of HIV, hepatitis, and other viral illness for the last 20 years. The studies conducted at OIC have been at the vanguard of prevention and treatment for many other viral infections. “By using our relationships with private sponsor corporations that are now working hard and expeditiously to develop a successful COVID-19 vaccine, we can offer Central Floridians the opportunity to participate in this pivotal and potentially game-changer study, and to get vaccinated earlier than the average citizen” explains Dr. Edwin DeJesus, OIC Medical Director.
AstraZeneca and the University of Oxford today announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.
Overview of the COVID-19 Prevention Network
Who We Are
The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the networks to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus.
Our Mission
To Conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease.
The Studies
The CoVPN expects to open four Phase III vaccine efficacy trials – trials that make sure the vaccine works - in 2020, with the potential for additional trials to follow. Each study is anticipated to enroll roughly 30,000 people, and participants will either get the vaccine product or a sterile saltwater injection (placebo). Some trials may be conducted only in the United States, while others will enroll global communities.
The Study Populations
These efficacy trials hope to enroll persons who are at risk for exposure to SARS-CoV-2. This risk could be associated with, but is not limited to:
• Working in an essential job, such as healthcare professions, emergency response personnel, grocery workers, meat-packing plants, etc.;
• Living in densely populated residential environments;
• Living or working in congregated living facilities such as correctional facilities or nursing homes;
• Being a member of a community that has been disproportionately impacted by this pandemic, such as older persons, persons with underlying health conditions, and racial/ethnic groups such as African Americans, Latinx, and Native American populations.
What Study Volunteers Can Expect
Before joining:
• When a potential participant contacts one of the participating study clinics, they will be provided information about the research being done.
• Potential participants will be asked personal questions before coming into the study clinic to help determine their potential for study eligibility. Determining eligibility can include things like asking about their medical history and doing a physical exam. Sometimes a blood sample will be drawn for necessary lab tests.
• Study clinics will provide information about the study to enable people to make an informed decision about whether or not to join the study. Specific details about each study will be provided during the informed consent process.
During the study:
• Most studies require coming into the study clinic for 10 or more visits over 1-2 years.
• Every study involves getting injections or infusions. These are not given at every visit, and the number and schedule will vary with each study.
• Participants will be asked to keep track of how they are feeling using an online diary for about a week following each infusion or injection.
• If a participant becomes infected with COVID-19, the study staff will provide care or direct participants to care.
• Study participants are compensated for their time, travel, and inconvenience while enrolled in the study.
After the study:
• We may ask if we can contact participants again for another study.
• When the study is complete, the results will be disseminated to all participants and their communities without any identifying information.
