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Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae

NCT02116998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2018-04-06

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will receive up to 3 doses at 4 week intervals.

Following the third dose, subjects will be inoculated intranasally with S. pneumoniae serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained pre-inoculation, and then 2, 7 and 14 days after inoculation.

Subjects will also be monitored for safety and tolerability throughout the dosing period, and then for 12 months after their last dose.

The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing colonization rates and magnitude of colonization following the S. pneumoniae challenge.

Conditions

  • Pneumococcal Infections
  • Pneumonia, Pneumococcal

Interventions

BIOLOGICAL

GEN-004 with Aluminum Hydroxide Adjuvant

GEN-004: 100 µg of each antigen, with adjuvant, 350 µg aluminum hydroxide, administered as a 0.5 mL intramuscular (IM) injection. GEN-004 is a recombinant S. pneumoniae protein subunit vaccine consisting of 3 recombinant T cell antigens: * GB104: ABC transporter, substrate-binding protein * GB144: Maltose/maltodextrin binding protein, ABC transporter * GB152: Hypothetical protein GEN-004 is filled in 2 mL vials containing 0.5 mL (350 µg/mL of each antigen). Aluminum hydroxide adjuvant is filled in 2 mL vials containing 1 mL at a concentration of 5 mg/mL.

BIOLOGICAL

Placebo

Placebo: normal saline, 0.5 mL per dose, IM.

BIOLOGICAL

Streptococcus pneumoniae inoculation

Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Fitzgerald, MD · Royal Liverpool University Hospital

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
2014-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United Kingdom

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 NCT02116998 on ClinicalTrials.gov