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

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ClinicalTrials.gov Identifier: NCT02116998
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Genocea Biosciences, Inc.

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.


Condition or disease Intervention/treatment Phase
Pneumococcal Infections Pneumonia, Pneumococcal Biological: GEN-004 with Aluminum Hydroxide Adjuvant Biological: Placebo Biological: Streptococcus pneumoniae inoculation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Intranasal Challenge With S. Pneumoniae
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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 Name: GEN-004

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

Placebo Comparator: Placebo Biological: Placebo
Placebo: normal saline, 0.5 mL per dose, IM.
Other Names:
  • Saline
  • Normal saline

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety and tolerability of GEN-004 with aluminum hydroxide [ Time Frame: 56 weeks ]
  2. Duration of S. pneumoniae colonization through 14 days after inoculation [ Time Frame: 12 weeks ]
  3. 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 ]
  4. Impact of GEN-004 on the density of colonization as measured by S. pneumoniae colony forming units (CFUs) post-inoculation [ Time Frame: 56 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116998


Locations
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United Kingdom
Royal Liverpool University Hospital, Liverpool School of Tropical Medicine
Liverpool, United Kingdom, L35QA
Sponsors and Collaborators
Genocea Biosciences, Inc.
Investigators
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Principal Investigator: Richard Fitzgerald, MD Royal Liverpool University Hospital

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Responsible Party: Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02116998     History of Changes
Other Study ID Numbers: GEN-004-002
2014-000944-13 ( EudraCT Number )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Keywords provided by Genocea Biosciences, Inc.:
GEN-004
Aluminum hydroxide
Vaccine
Streptococcus pneumoniae
Pneumococcal Infections
Strep pneumoniae
Pneumonia
Additional relevant MeSH terms:
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Gram-Positive Bacterial Infections
Pneumococcal Infections
Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Bacterial Infections
Pneumonia, Bacterial
Aluminum Hydroxide
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents