Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory
(breathing) system. The purpose of this study is to evaluate the safety and protective
(immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An
adjuvant is a substance that may be added to a vaccine to improve the immune response so that
less of the vaccine may need to be given. Study participants will include 72 volunteers, ages
18-40, living in the Houston, Texas area. The study will take place at Baylor College of
Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to
look like the study vaccine but contains no medication) given 1 month apart. Participants
will fill out a memory aid (diary) to document daily temperature and illness signs and
symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples
will be collected. Participants will be in the study for up to 211 days, including screening.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)