Covid 19 Research using Clinical Trials (Home Page)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
Correlated MeSH Terms (1)
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D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
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There is one clinical trial.
Clinical Trials
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.
NCT00533741 Coronavirus (SARS-CoV) Drug: Aluminum hydroxide Drug: Placebo Biological: SARS-CoV
Primary Outcomes
Measure: Frequency and description of serious adverse events (SAEs). Time: 5 months after receipt of the booster dose of vaccine.
Measure: Frequency of significant increases in serum antibody to CoV S protein in Enzyme Linked Immunosorbent Assay (ELISA) and in neutralization tests, and increases in Geometric Mean Titers (GMT)s in sera. Time: Screening, 1 and 5 months after the booster dose of vaccine.
Measure: Frequency and severity of solicited injection site and systemic signs and symptoms and unsolicited adverse events (AE) / SAEs. Time: 1 month after receipt of the first and second doses of vaccine.
Secondary Outcomes
Measure: Frequency of significant serum antibody increases and increases in Geometric Mean Titers (GMT)s, as measured in neutralizing antibody tests and an ELISA against SARS-CoV S protein. Time: Collected just before the first vaccination and at 1 month (just before booster).
No related HPO nodes (Using clinical trials)