Pneumococcal InfectionsPhase 2NCT02116998
Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae
A Phase 2 study testing GEN-004 with Aluminum Hydroxide Adjuvant and Streptococcus pneumoniae inoculation in people with Pneumococcal Infections and Pneumonia, Pneumococcal, run by Genocea Biosciences, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections, Pneumonia, Pneumococcal
- What is being tested?
- GEN-004 with Aluminum Hydroxide Adjuvant and Streptococcus pneumoniae inoculation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool University Hospital, Liverpool School of Tropical Medicine
Liverpool, L35QA
About this study
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
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.
Read more
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.
- Conditions
- Pneumococcal Infections, Pneumonia, Pneumococcal
- Being tested
- GEN-004 with Aluminum Hydroxide Adjuvant, Placebo, Streptococcus pneumoniae inoculation
- Keywords
- GEN-004, Aluminum hydroxide, Vaccine, Streptococcus pneumoniae, Pneumococcal Infections, Strep pneumoniae, Pneumonia
- Medical subject headings
- Pneumococcal Infections, Pneumonia, Pneumococcal, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN-004 with Aluminum Hydroxide AdjuvantBiological
Also called GEN-004
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.
PlaceboBiological
Also called Saline, Normal saline
Placebo: normal saline, 0.5 mL per dose, IM.
Streptococcus pneumoniae inoculationBiological
Also called S. Pneumoniae
Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.
| Study group | Role | What they receive |
|---|---|---|
| GEN-004 with Aluminum Hydroxide | Experimental | Not described Receives: Biological: GEN-004 with Aluminum Hydroxide Adjuvant; Biological: Streptococcus pneumoniae inoculation |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo; Biological: Streptococcus pneumoniae inoculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 56 weeks
Secondary outcomes (4)
Safety and tolerability of GEN-004 with aluminum hydroxide
Measured: 56 weeks
Duration of S. pneumoniae colonization through 14 days after inoculation
Measured: 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
Measured: 56 weeks
Impact of GEN-004 on the density of colonization as measured by S. pneumoniae colony forming units (CFUs) post-inoculation
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genocea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Fitzgerald, MD, Principal investigator, Royal Liverpool University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116998
- Sponsor's protocol ID
- GEN-004-002
- Other IDs
- 2014-000944-13, 2014
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2014
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02116998
- Acronym / sponsor ID
- GEN-004-002
- Conditions
- Pneumococcal Infections, Pneumonia, Pneumococcal
- Keywords
- GEN-004, Aluminum hydroxide, Vaccine, Streptococcus pneumoniae, Pneumococcal Infections, Strep pneumoniae, Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEN-004 with Aluminum Hydroxide | Experimental | Biological: GEN-004 with Aluminum Hydroxide Adjuvant, Biological: Streptococcus pneumoniae inoculation |
| Placebo | Placebo comparator | Biological: Placebo, Biological: Streptococcus pneumoniae inoculation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEN-004 with Aluminum Hydroxide AdjuvantAlso: GEN-004GEN-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. | Biological | GEN-004 with Aluminum Hydroxide |
| PlaceboAlso: Saline, Normal salinePlacebo: normal saline, 0.5 mL per dose, IM. | Biological | Placebo |
| Streptococcus pneumoniae inoculationAlso: S. PneumoniaeIntranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B. | Biological | GEN-004 with Aluminum Hydroxide, Placebo |
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Fitzgerald, MD principal investigator
Royal Liverpool University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GEN-004 with Aluminum Hydroxide Adjuvant and Streptococcus pneumoniae inoculation in people with Pneumococcal Infections and Pneumonia, Pneumococcal, run by Genocea Biosciences, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.