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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Intranasa

Brief 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.


Detailed Summary:
Sponsor: Genocea Biosciences, Inc.

Current Primary Outcome: 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 ]

Original Primary Outcome: Efficacy of GEN-003 as measured by reduction in nasopharyngeal colonization [ Time Frame: 56 weeks ]

The primary objectives of this study are to evaluate the efficacy of GEN-004 with aluminum hydroxide in healthy adult subjects to reduce nasopharyngeal colonization following intranasal inoculation with S. pneumoniae serotype 6B and to evaluate the impact of GEN-004 on the magnitude of colonization as measured by S. pneumoniae CFUs post-inoculation.


Current Secondary Outcome:

  • Safety and tolerability of GEN-004 with aluminum hydroxide [ Time Frame: 56 weeks ]
  • Duration of S. pneumoniae colonization through 14 days after inoculation [ Time Frame: 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 ]
  • Impact of GEN-004 on the density of colonization as measured by S. pneumoniae colony forming units (CFUs) post-inoculation [ Time Frame: 56 weeks ]


Original Secondary Outcome:

  • Evaluation of the safety and tolerability of GEN-004 with aluminum hydroxide as measured by frequency and severity of Adverse Events [ Time Frame: 56 weeks ]
  • Evaluation of the duration of S. pneumoniae colonization through 14 days after inoculation [ Time Frame: 12 weeks ]
  • Evaluation of the immunogenicity of GEN-004 with aluminum hydroxide, as measured by TH17 (IL-17) and IgG responses to the antigens. [ Time Frame: 56 weeks ]


Information By: Genocea Biosciences, Inc.

Dates:
Date Received: April 11, 2014
Date Started: September 2014
Date Completion:
Last Updated: May 25, 2016
Last Verified: May 2016