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Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine

NCT ID: NCT01995617

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Streptococcus Pneumoniae

Keywords

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vaccine Streptococcus pneumoniae Strep pneumo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low Dose (Cohort 1)

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

normal saline, 0.5 mL per dose

GEN-004 Low Dose

Intervention Type BIOLOGICAL

The GEN-004 Low Dose contains 10µg of each of the three antigens.

GEN-004 Low Dose + Adjuvant

Intervention Type BIOLOGICAL

The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

Mid Dose (Cohort 2)

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

normal saline, 0.5 mL per dose

GEN-004 Mid Dose

Intervention Type BIOLOGICAL

The GEN-004 Mid Dose contains 30µg of each of the three antigens.

GEN-004 Mid Dose + Adjuvant

Intervention Type BIOLOGICAL

The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

High Dose (Cohort 3)

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

normal saline, 0.5 mL per dose

GEN-004 High Dose

Intervention Type BIOLOGICAL

The GEN-004 High Dose contains 100µg of each of the three antigens.

GEN-004 High Dose + Adjuvant

Intervention Type BIOLOGICAL

The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

Interventions

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Placebo

normal saline, 0.5 mL per dose

Intervention Type BIOLOGICAL

GEN-004 Low Dose

The GEN-004 Low Dose contains 10µg of each of the three antigens.

Intervention Type BIOLOGICAL

GEN-004 Low Dose + Adjuvant

The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

Intervention Type BIOLOGICAL

GEN-004 Mid Dose

The GEN-004 Mid Dose contains 30µg of each of the three antigens.

Intervention Type BIOLOGICAL

GEN-004 Mid Dose + Adjuvant

The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

Intervention Type BIOLOGICAL

GEN-004 High Dose

The GEN-004 High Dose contains 100µg of each of the three antigens.

Intervention Type BIOLOGICAL

GEN-004 High Dose + Adjuvant

The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Males and non-pregnant females, ages 18 to 55 years inclusive.
2. Willing and able to provide written informed consent.
3. Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
4. 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.

Exclusion Criteria

1. 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.
2. Presence or history of autoimmune disease, regardless of current treatment.
3. Insulin dependent diabetes.
4. Positive serologic test for HIV-1 or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
5. Screening serum chemistry or hematology abnormality ≥ Grade 1.
6. Screening urinalysis abnormality ≥ Grade 2.
7. Positive urine drug screen or alcohol Breathalyzer test at Screening or on Study Day 1.
8. 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.
9. Any acute illness including, fever (\>100.4 degrees F \[\> 38 degrees C\]) within 3 days prior to the first dose of Study Drug.
10. Pregnant or nursing women.
11. Receipt of any investigational drug within 30 days prior to the first dose of Study Drug.
12. Receipt of blood products within 90 days prior to the first dose of Study Drug.
13. Donation of blood or plasma within 56 days prior to Screening.
14. 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.
15. Prior vaccination with pneumococcal vaccine.
16. History of hypersensitivity to any component of the vaccine or history of an allergic reaction to an immunization.
17. History of invasive pneumococcal disease (i.e., sepsis, meningitis or pneumonia with bacteremia).
18. 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.
19. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genocea Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Matson, MD

Role: PRINCIPAL_INVESTIGATOR

Prism Research

Locations

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Prism Research

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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GEN-004-001

Identifier Type: -

Identifier Source: org_study_id