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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pneumococcal Infections
- Sponsor
- Genocea Biosciences, Inc.
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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
- Safety and tolerability of GEN-004 with aluminum hydroxide(56 weeks)
- Duration of S. pneumoniae colonization through 14 days after inoculation(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(56 weeks)
- Impact of GEN-004 on the density of colonization as measured by S. pneumoniae colony forming units (CFUs) post-inoculation(56 weeks)