Streptococcus PneumoniaePhase 1NCT01995617
Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine
A Phase 1 study testing GEN-004 Low Dose, GEN-004 Low Dose + Adjuvant and GEN-004 Mid Dose in people with Streptococcus Pneumoniae, run by Genocea Biosciences, Inc. at 1 site in United States.
Trial summary
GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae
- What is being tested?
- GEN-004 Low Dose, GEN-004 Low Dose + Adjuvant and GEN-004 Mid Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2015
- Phase
- Phase 1
- 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.
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- Willing to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, barrier methods such as condoms, diaphragms, intrauterine devices, and licensed hormonal methods for 28 days before and 90 days after receiving Study Drug.
Who cannot join
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 µg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
- Presence or history of autoimmune disease, regardless of current treatment.
- Insulin dependent diabetes.
- Positive serologic test for HIV-1 or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
- Screening serum chemistry or hematology abnormality ≥ Grade 1.
- Screening urinalysis abnormality ≥ Grade 2.
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- Positive urine drug screen or alcohol Breathalyzer test at Screening or on Study Day 1.
- 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 the first dose of Study Drug.
- Any acute illness including, fever (>100.4 degrees F [> 38 degrees C]) within 3 days prior to the first dose of Study Drug.
- Pregnant or nursing women.
- Receipt of any investigational drug within 30 days prior to the first dose of Study Drug.
- Receipt of blood products within 90 days prior to the first dose of Study Drug.
- Donation of blood or plasma within 56 days prior to Screening.
- Receipt of a live vaccine within 28 days prior or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug.
- Prior vaccination with pneumococcal vaccine.
- History of hypersensitivity to any component of the vaccine or history of an allergic reaction to an immunization.
- History of invasive pneumococcal disease (i.e., sepsis, meningitis or pneumonia with bacteremia).
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to comply with the study requirements.
- Any other condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of GEN-004, a Streptococcus Pneumoniae Protein Subunit Vaccine, in Adult Subjects
GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo, respectively. Each subject will receive up to 3 doses at 4 week intervals.
Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after their last dose.
- Conditions
- Streptococcus Pneumoniae
- Being tested
- Placebo, GEN-004 Low Dose, GEN-004 Low Dose + Adjuvant, GEN-004 Mid Dose, GEN-004 Mid Dose + Adjuvant
- Keywords
- vaccine, Streptococcus pneumoniae, Strep pneumo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
normal saline, 0.5 mL per dose
GEN-004 Low DoseBiological
The GEN-004 Low Dose contains 10µg of each of the three antigens.
GEN-004 Low Dose + AdjuvantBiological
The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
GEN-004 Mid DoseBiological
The GEN-004 Mid Dose contains 30µg of each of the three antigens.
GEN-004 Mid Dose + AdjuvantBiological
The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
GEN-004 High DoseBiological
The GEN-004 High Dose contains 100µg of each of the three antigens.
GEN-004 High Dose + AdjuvantBiological
The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose (Cohort 1) | Experimental | Not described Receives: Biological: Placebo; Biological: GEN-004 Low Dose; Biological: GEN-004 Low Dose + Adjuvant |
| Mid Dose (Cohort 2) | Experimental | Not described Receives: Biological: Placebo; Biological: GEN-004 Mid Dose; Biological: GEN-004 Mid Dose + Adjuvant |
| High Dose (Cohort 3) | Experimental | Not described Receives: Biological: Placebo; Biological: GEN-004 High Dose; Biological: GEN-004 High Dose + Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of GEN-004 when administered with and without aluminum hydroxide to adult subjects.
Measured: 12 months after third (last) dose
Secondary outcomes (2)
To evaluate the immunogenicity of GEN-004, as measured by TH17 (IL-17) and IgG responses to the antigens, when administered with and without aluminum hydroxide.
Measured: 12 months after third (last) dose
To evaluate the durability of immune responses up to 12 months after the last dose.
Measured: 12 months after third (last) dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus PneumoniaeStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genocea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, MD, Principal investigator, Prism Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995617
- Sponsor's protocol ID
- GEN-004-001
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of GEN-004, a Streptococcus Pneumoniae Protein Subunit Vaccine, in Adult Subjects
- ClinicalTrials.gov ID
- NCT01995617
- Acronym / sponsor ID
- GEN-004-001
- Conditions
- Streptococcus Pneumoniae
- Keywords
- vaccine, Streptococcus pneumoniae, Strep pneumo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Genocea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Nov 2013 (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.
GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo, respectively. Each subject will receive up to 3 doses at 4 week intervals.
Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after their last dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose (Cohort 1) | Experimental | Biological: Placebo, Biological: GEN-004 Low Dose, Biological: GEN-004 Low Dose + Adjuvant |
| Mid Dose (Cohort 2) | Experimental | Biological: Placebo, Biological: GEN-004 Mid Dose, Biological: GEN-004 Mid Dose + Adjuvant |
| High Dose (Cohort 3) | Experimental | Biological: Placebo, Biological: GEN-004 High Dose, Biological: GEN-004 High Dose + Adjuvant |
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.
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- Willing to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, barrier methods such as condoms, diaphragms, intrauterine devices, and licensed hormonal methods for 28 days before and 90 days after receiving Study Drug.
Key exclusion criteria (20 listed)
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 µg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
- Presence or history of autoimmune disease, regardless of current treatment.
- Insulin dependent diabetes.
- Positive serologic test for HIV-1 or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
- Screening serum chemistry or hematology abnormality ≥ Grade 1.
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 |
|---|---|---|
| Placebonormal saline, 0.5 mL per dose | Biological | High Dose (Cohort 3), Low Dose (Cohort 1), Mid Dose (Cohort 2) |
| GEN-004 Low DoseThe GEN-004 Low Dose contains 10µg of each of the three antigens. | Biological | Low Dose (Cohort 1) |
| GEN-004 Low Dose + AdjuvantThe GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant. | Biological | Low Dose (Cohort 1) |
| GEN-004 Mid DoseThe GEN-004 Mid Dose contains 30µg of each of the three antigens. | Biological | Mid Dose (Cohort 2) |
| GEN-004 Mid Dose + AdjuvantThe GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant. | Biological | Mid Dose (Cohort 2) |
| GEN-004 High DoseThe GEN-004 High Dose contains 100µg of each of the three antigens. | Biological | High Dose (Cohort 3) |
| GEN-004 High Dose + AdjuvantThe GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant. | Biological | High Dose (Cohort 3) |
Primary outcome
To evaluate the safety and tolerability of GEN-004 when administered with and without aluminum hydroxide to adult subjects.
Time frame: 12 months after third (last) dose
2 secondary outcomes
To evaluate the immunogenicity of GEN-004, as measured by TH17 (IL-17) and IgG responses to the antigens, when administered with and without aluminum hydroxide.
Time frame: 12 months after third (last) dose
To evaluate the durability of immune responses up to 12 months after the last dose.
Time frame: 12 months after third (last) dose
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 11 Dec 2015.
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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.
Mark Matson, MD principal investigator
Prism Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEN-004 Low Dose, GEN-004 Low Dose + Adjuvant and GEN-004 Mid Dose in people with Streptococcus Pneumoniae, run by Genocea Biosciences, Inc. at 1 site in United States.
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 20 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 11 Dec 2015. 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 States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the safety and tolerability of GEN-004 when administered with and without aluminum hydroxide to adult subjects. (time frame: 12 months after third (last) dose). 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 11 Dec 2015.