Covid 19 Research using Clinical Trials (Home Page)
Phosphate buffered saline PlaceboWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
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Name (Synonyms) |
Correlation |
drug617 | Placebo (Plasma-Lyte 148) Wiki | 1.00 |
drug43 | Aluminum hydroxide adjuvant (Alhydrogel®) Wiki | 1.00 |
drug356 | Human umbilical cord derived CD362 enriched MSCs Wiki | 1.00 |
drug685 | Recombinant S protein SARS vaccine Wiki | 1.00 |
Correlated MeSH Terms (4)
Correlated HPO Terms (0)
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Name (Synonyms) |
Correlation |
There is one clinical trial.
Clinical Trials
This is a multi-center, randomized, double-blinded, placebo-controlled, outpatient study.
Recombinant deltaTM S Protein Severe Acute Respiratory Syndrome (SARS) Vaccine With and
Without Aluminum Hydroxide Adjuvant (Provided through contract N01-AI-30023, manufactured by
Protein Sciences Corporation), two doses, administered at 28 day interval. 1. S Protein
Severe Acute Respiratory Syndrome (SARS) Vaccine without adjuvant: 5.0, 15.0 and 45.0 mcg per
0.5 ml dose. 2. S Protein SARS Adjuvanted Vaccine: 5.0, 15.0 and 45.0 mcg per 0.5 ml dose.
PLACEBO: diluents/placebo without vaccine (Phosphate Buffer Saline (PBS) with lower phosphate
concentration). Approximately 84 healthy male and nonpregnant female subjects 18 to 40 years
of age will be enrolled.
NCT01376765 SARS Drug: Aluminum hydroxide adjuvant (Alhydrogel®) Other: Phosphate buffered saline Placebo Biological: Recombinant S protein SARS vaccine
Primary Outcomes
Measure: Occurrence of solicited local and systemic adverse events (AE)within 8 days after vaccination (Days 0-7 and Days 28-35) Time: 8 days after vaccination (Days 0-7 and Days 28-35)
Measure: Incidence of vaccine-related serious adverse events (SAEs) throughout the duration of the study. Time: Day 0 to Day 758
Measure: Occurrence of laboratory abnormalities at 8 days after vaccination (Days 8 and 36) Time: 8 days after vaccination (Days 8 and 36)
Secondary Outcomes
Measure: Immunogenicity: Proportion of subjects achieving a detectable serum neutralizing antibody titer against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (approximately Day 56) Time: 28 days after receipt of the second dose of vaccine (approximately Day 56)
Measure: Immunogenicity: GMT of neutralizing antibody titers against SARS-CoV in each immunized group 28 days after receipt of the second dose of vaccine (Day 56). Measurement will include the Day 56 GMT and the mean fold change (GMT ratio Day 56:Day 0) Time: 28 days after receipt of the second dose of vaccine (Day 56)
Measure: Comparison of rates of unsolicited AEs related to vaccine for all subjects between treatment groups and in the combined cohorts receiving vaccine with aluminum hydroxide adjuvant compared with those receiving vaccine with no adjuvant. Time: intervals from Days 0-7, Days 0-28, Days 8-28, Days 0-56, Days 29-36, and Days 29-56.
Measure: Immunogenicity: Geometric Mean Titer (GMT) of antibody titers (IgG ELISA for S protein of SARS-CoV) 28 days after receipt of the second dose of vaccine (Day 56) at each vaccine dose level, with and without adjuvant Time: 28 days after receipt of the second dose of vaccine (Day 56)
No related HPO nodes (Using clinical trials)