NCT01995617

Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of GEN-004, a Streptococcus Pneumoniae Protein Subunit Vaccine, in Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Genocea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo, respectively. Each subject will receive up to 3 doses at 4 week intervals. Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after their last dose.

Conditions

• Streptococcus Pneumoniae

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	normal saline, 0.5 mL per dose
BIOLOGICAL	GEN-004 Low Dose	The GEN-004 Low Dose contains 10µg of each of the three antigens.
BIOLOGICAL	GEN-004 Low Dose + Adjuvant	The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
BIOLOGICAL	GEN-004 Mid Dose	The GEN-004 Mid Dose contains 30µg of each of the three antigens.
BIOLOGICAL	GEN-004 Mid Dose + Adjuvant	The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
BIOLOGICAL	GEN-004 High Dose	The GEN-004 High Dose contains 100µg of each of the three antigens.
BIOLOGICAL	GEN-004 High Dose + Adjuvant	The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-11-26
• Last updated: 2015-12-11

Locations

1 site across 1 country: United States