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NCT Number: NCT02116998

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

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumonia Pneumonia, Bacterial Pneumonia, Pneumococcal Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Liverpool University Hospital, Liverpool School of Tropical Medicine

Liverpool, L35QA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GEN-004 with Aluminum Hydroxide Adjuvant

Biological

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

Placebo

Biological

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

Other names: Saline, Normal saline

Streptococcus pneumoniae inoculation

Biological

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

Other names: S. Pneumoniae

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genocea Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2014
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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