Phase I Dose Escalation SARS-CoV Recombinant S Protein, With and Without Adjuvant, Vaccine Study

Summary

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.

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