The Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health has begun enrolling study participants into a Phase 2/3 COVID-19 vaccine trial sponsored by BioNTech in collaboration with Pfizer. The Center is one of approximately 120 sites around the world that will evaluate a novel mRNA COVID-19 investigational vaccine. About 30,000 participants will be enrolled in the study, which aims to validate promising safety and efficacy data obtained from Phase 1/2 clinical evaluation of the vaccine candidate earlier this year. Kawsar Talaat, MD, an assistant professor in the Department of International Health at the Bloomberg School, is the Johns Hopkins site PI. The Center will enroll study participants 18 to 85 years old and will include healthy participants and participants with stable disease.1 Study participants for the Johns Hopkins site will be enrolled at the CIR’s Isolation Unit. The unit is located on the Johns Hopkins Bayview Medical Campus and is 6,567 square feet with a self-contained ventilation system, making it an ideal environment to conduct vaccine trials for respiratory illnesses like coronavirus.
The vaccine candidate, called BNT162b2, is one of four investigational vaccines evaluated during Pfizer’s Phase 1/2 trial. BNT162b2 produced the favorable immune and tolerability profiles of the four initial candidates. According to a Pfizer press release, it “induced favorable viral antigen specific CD4+ and CD8+T cell responses, high levels of neutralizing antibody in various animal species, and beneficial protective effects in a primate SARS-CoV-2 challenge model,” and was thus selected to move on to the Phase 2/3 clinical evaluation. Participants in this trial will receive two 30 μg doses of the vaccine or placebo during the first study visit. After they receive the study product, they will be followed for two years to collect safety and efficacy data, returning to the Center for scheduled follow-up visits during this period. People interested in participating in this study should call 410-955-7283 for more information.
1. Stable disease: disease not requiring significant change in therapy or hospitalization for worsening disease during the six weeks before enrollment
