MedTrace Logo

Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine

NCT01995617 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-12-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Matson, MD · Prism Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01995617 on ClinicalTrials.gov