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

April 4, 2018 updated by: Genocea Biosciences, Inc.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GEN-004, a Pneumococcal Protein Subunit Vaccine, on Colonization Following Intranasal Challenge With S. Pneumoniae

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L35QA
        • Royal Liverpool University Hospital, Liverpool School of Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and non-pregnant females, ages 18 to 55 years inclusive.
  • Willing and able to provide written informed consent.
  • Fluent English speakers only (for safety reasons)
  • Willing to perform and comply with all study procedures including attending clinic visits as scheduled.

Exclusion Criteria:

  • Prior vaccination with pneumococcal vaccine.
  • History of invasive pneumococcal disease (i.e., sepsis, meningitis or pneumonia with bacteremia).
  • Close contact with at risk individuals (young children [under 5years], immunosuppressed adults, elderly, chronic ill health).
  • Current smoker or significant smoking history (>10 pack years).
  • Pregnant or breast-feeding woman.
  • Women of child-bearing potential (WOCBP) who are deemed not to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination.
  • Allergy to penicillin or amoxicillin.
  • Any screening laboratory value > Grade 1
  • Positive serologic test for HIV-1 or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
  • Asthma (on regular medication) or other respiratory disease.
  • Immunocompromised individuals, including those receiving corticosteroids or other immunosuppressive agents.
  • Presence or history of auto-immune disease (refer to Appendix 4) regardless of current treatment.
  • No antibiotic treatment within 1 week of inoculation
  • Previous involvement in EHPC study inoculated with pneumococcal bacteria
  • In any other clinical trial unless in observational stage or follow-up
  • Diabetes, type 1 or type 2.
  • Other active, uncontrolled co-morbidities that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.

NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to first dose of Study Drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Streptococcus pneumoniae inoculation
Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.
Other Names:
  • S. Pneumoniae
Biological: Placebo
Placebo: normal saline, 0.5 mL per dose, IM.
Other Names:
  • Saline
  • Normal saline
Experimental: GEN-004 with Aluminum Hydroxide
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.

Other Names:
  • GEN-004
Biological: Streptococcus pneumoniae inoculation
Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.
Other Names:
  • S. Pneumoniae

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of GEN-004 with aluminum hydroxide in healthy adult subjects to reduce nasopharyngeal colonization following intranasal inoculation with S. pneumoniae serotype 6 as measured by proportion of colonized subjects
Time Frame: 56 weeks
56 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of GEN-004 with aluminum hydroxide
Time Frame: 56 weeks
56 weeks
Duration of S. pneumoniae colonization through 14 days after inoculation
Time Frame: 12 weeks
12 weeks
Immunogenicity of GEN-004 with aluminum hydroxide, as measured by TH17 (IL-17) and IgG responses to the vaccine antigens in sera and nasal fluid
Time Frame: 56 weeks
56 weeks
Impact of GEN-004 on the density of colonization as measured by S. pneumoniae colony forming units (CFUs) post-inoculation
Time Frame: 56 weeks
56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genocea Biosciences, Inc.

Investigators

  • Principal Investigator: Richard Fitzgerald, MD, Royal Liverpool University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 17, 2014

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-004-002
  • 2014-000944-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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