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Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767402
First Posted: January 14, 2013
Last Update Posted: January 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this study is to examine the safety, reactogenicity and immunogenicity of the GlaxoSmithKline (GSK) Biologicals candidate pneumococcal vaccine containing PhtD in healthy elderly population aged 18-45 years of age.

Condition Intervention Phase
Pneumococcal Disease Biological: PhtD vaccine with/without adjuvant Biological: Pneumovax 23TM Biological: NaCl Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations According to a 0-2 Month Schedule, in Healthy Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and relationship of any solicited local and general signs and symptoms [ Time Frame: During a 7-day follow up period (i.e. Days 0-6) after each vaccine dose ]
  • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose ]
  • Occurrence of all serious adverse events (SAEs) [ Time Frame: During the 12 months of the study ]
  • Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA) [ Time Frame: One month after the first injection ]
  • Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA) [ Time Frame: One month after two injections ]

Secondary Outcome Measures:
  • Number and percentage of subjects with normal or abnormal values, for biochemical assessments and for hematological analysis [ Time Frame: At month 0, 1, 3 and 12 ]
  • Anti-PhtD antibody concentration in all groups (measured by ELISA) [ Time Frame: At 12 months after the first vaccination ]
  • Anti-PhtD antibody avidity (measured by ELISA) [ Time Frame: At month 0, 1, 3 and 12 ]
  • Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals (passive transfer mice model assay) [ Time Frame: At month 0, 1, 3 and 12 ]
  • Frequency of PhtD-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (measured by B-cell ELISPOT) [ Time Frame: At month 0, 3 and 12 ]
  • Frequency of CD4 and/or CD8 T cells that produce cytokines IL-2, IL-4, IFNg, CD40L and/or GM-CSF, upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects (measured by intracellular cytokine cytometry) [ Time Frame: At month 0, 3 and 12 ]
  • Anti-polysaccharide total gamma class immunoglobulin (IgG) concentration in the 23 valent Polysaccharide Pneumococcal Vaccine(23 PPV) group for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) (ELISA) [ Time Frame: At month 0, 1 and 12 ]
  • Opsonophagocytic activity titers in the 23 PPV group for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F (OPA assay) [ Time Frame: At month 0, 1 and 12 ]
  • Frequency of polysaccharide(PS)-specific plasma cells generated by in vitro cultivated memory B-cells in the 23 PPV group in a subset of subjects (measured by B-cell ELISPOT) [ Time Frame: At month 0, 1 and 12 ]
  • Circulating serum cytokines Interferon-gamma (INFγ) and Tumor necrosis factor-alpha (TNFα) content in all groups (measured by ELISA) [ Time Frame: At Day 0, 1, 60 and 61 ]

Enrollment: 150
Study Start Date: October 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PhtD Group 1
Subjects will receive PhtD vaccine formulation 1 without any adjuvant.
Biological: PhtD vaccine with/without adjuvant
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Experimental: PhtD Group 2
Subjects will receive adjuvanted PhtD vaccine formulation 2.
Biological: PhtD vaccine with/without adjuvant
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Experimental: PhtD Group 3
Subjects will receive adjuvanted PhtD vaccine formulation 3.
Biological: PhtD vaccine with/without adjuvant
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Experimental: PhtD Group 4
Subjects will receive adjuvanted PhtD vaccine formulation 4.
Biological: PhtD vaccine with/without adjuvant
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Experimental: PhtD Group 5
Subjects will receive adjuvanted PhtD vaccine formulation 5.
Biological: PhtD vaccine with/without adjuvant
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Active Comparator: 23 PPV Group
Subjects will receive the Pneumovax 23TM vaccine and NaCl.
Biological: Pneumovax 23TM
One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
Biological: NaCl
One dose administered intramuscularly in the deltoid region of the right arm at month 2.

Detailed Description:
The safety profile of the PhtD vaccine will be assessed in comparison to a comparator vaccine (Pneumovax 23TM). In order to further increase the immune response to vaccination, a novel adjuvant system will also be examined.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 45 years at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Use of any anticoagulants.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
  • Previous vaccination against Streptococcus pneumoniae.
  • Bacterial pneumonia within 3 years prior to 1st vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Current serious neurologic or mental disorders.
  • Inflammatory processes such as known chronic active infections.
  • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
  • History of administration of an experimental vaccine containing 3-deacylated Monophosphoryl Lipid A (MPL) or Quillaja saponaria 21 (QS21).
  • Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature <37.5°C or Axillary temperature <37.5°C.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or intravenous drug abuse.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767402


Locations
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767402     History of Changes
Other Study ID Numbers: 100417
First Submitted: January 10, 2013
First Posted: January 14, 2013
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by GlaxoSmithKline:
Safety
Pneumococcal Infections
Immunogenicity
PhtD vaccine
Healthy adults
Reactogenicity

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs