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.
This is a Phase 1,multi-center, randomized, double-blinded, placebo-controlled, outpatient study in healthy male and nonpregnant female subjects 18 to 40 years of age, inclusive. Three dosing cohorts to investigate the safety, reactogenicity, and immunogenicity of Recombinant S protein Severe Acute Respiratory Syndrome (SARS) vaccine, with and without aluminum hydroxide adjuvant manufactured by Protein Sciences Corporation, administered intramuscularly on Days 0 and 28 at a dose of 5, 15, or 45 mcg; controls will receive the diluents/placebo without vaccine. Approximately 84 subjects are expected to be enrolled. All subjects will receive 2 doses of their assigned treatment via IM injection approximately 28 days apart, followed by assessments at 6, 12, 15, 18, 21 and 24 months after the second dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Aluminum hydroxide adjuvant (Alhydrogel®);given with SARS vaccine; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine with adjuvant at 45 micrograms per dose
Phosphate buffered saline Placebo; 2 intramuscular doses, 28 days apart. Cohort 1: 4 subjects given placebo at 5 micrograms per dose; Cohort 2: 4 subjects given placebo at 15 micrograms per dose; Cohort 3: 4 subjects given placebo at 45 micrograms per dose
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, United States
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States
Occurrence of solicited local and systemic adverse events (AE)within 8 days after vaccination (Days 0-7 and Days 28-35)
Time frame: 8 days after vaccination (Days 0-7 and Days 28-35)
Incidence of vaccine-related serious adverse events (SAEs) throughout the duration of the study.
Time frame: Day 0 to Day 758
Occurrence of laboratory abnormalities at 8 days after vaccination (Days 8 and 36)
Time frame: 8 days after vaccination (Days 8 and 36)
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 frame: 28 days after receipt of the second dose of vaccine (approximately Day 56)
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 frame: 28 days after receipt of the second dose of vaccine (Day 56)
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 frame: intervals from Days 0-7, Days 0-28, Days 8-28, Days 0-56, Days 29-36, and Days 29-56.
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 frame: 28 days after receipt of the second dose of vaccine (Day 56)
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Recombinant S protein severe acute respiratory syndrome (SARS) vaccine given with adjuvant or without adjuvant; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine only or vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine only or vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine only or vaccine with adjuvant at 45 micrograms per dose