Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine
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
1 other identifier
interventional
90
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedDecember 11, 2015
November 1, 2015
1.3 years
November 19, 2013
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of GEN-004 when administered with and without aluminum hydroxide to adult subjects.
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.
12 months after third (last) dose
To evaluate the durability of immune responses up to 12 months after the last dose.
12 months after third (last) dose
Study Arms (3)
Low Dose (Cohort 1)
EXPERIMENTALMid Dose (Cohort 2)
EXPERIMENTALHigh Dose (Cohort 3)
EXPERIMENTALInterventions
normal saline, 0.5 mL per dose
The GEN-004 Low Dose contains 10µg of each of the three antigens.
The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
The GEN-004 Mid Dose contains 30µg of each of the three antigens.
The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
The GEN-004 High Dose contains 100µg of each of the three antigens.
The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prism Research
Saint Paul, Minnesota, 55114, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Matson, MD
Prism Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 26, 2013
Study Start
November 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
December 11, 2015
Record last verified: 2015-11