NCT01376765

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

Phase I, Double-Blinded, Placebo-Controlled, Dose- Escalation Study of the Safety and Immunogenicity of Recombinant SARS-CoV deltaTM S Protein Vaccine Formulated With and Without Alhydrogel® in Healthy Adults When Administered by the Intramuscular Route

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• SARS

Interventions

Type	Name	Description
DRUG	Aluminum hydroxide adjuvant (Alhydrogel®)	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
OTHER	Phosphate buffered saline Placebo	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
BIOLOGICAL	Recombinant S protein SARS vaccine	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

Timeline

• First posted: 2011-06-20
• Last updated: 2013-02-15

Locations

3 sites across 1 country: United States