Grant: Operating Grant: Clinical Trials Projects

Group A streptococcus (Strep A) is a germ that causes several diseases, ranging from sore throat to devastating flesh-eating disease and rheumatic fever (heart disease). We have come up with new vaccine candidates that may protect against Strep A. We have finished testing these in pre-clinical studies and in a small group of human volunteers. The next step toward getting these vaccines ready for use in the vaccine clinic is to make sure they are safe and generate a robust immune response (antibodies) in healthy adults. We are planning to administer these vaccines to 30 healthy volunteers, carefully monitor for any possible side effects, and check the antibody response. These vaccines are new and unique because they use small pieces of a protein from Strep A, called peptides. This allows the vaccines to stimulate an immune response without creating side-effects such as immune attack on the heart valves or kidneys. The peptides are called J8, p*17, and K4S2. They will be administered in two combinations: J8-K4S2 and p*17-K4S2. Our study will begin with test doses of the new vaccines in a small number of healthy volunteers. This is to ensure that the vaccines are well tolerated. Then, we will proceed to a fully randomized (like flipping a coin) administration of the vaccine to more volunteers (total 30). Using a standardized checklist to carefully look for side-effects, we will be monitoring the volunteers after each dose of vaccine. We will also be checking their blood for antibodies to the peptides. If this study shows that the new vaccine is safe and that it generates a good antibody response, this will allow us to move forward along the vaccine development pipeline, testing the vaccine in a larger number of patients, and looking for its ability to protect against clinical disease. Ultimately, we aim to develop a vaccine that could be used in public health clinics to prevent serious Strep A illnesses.