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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767402
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Occurrence of all serious adverse events (SAEs) [ Time Frame: During the 12 months of the study ] [ Designated as safety issue: No ]
  • Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA) [ Time Frame: One month after the first injection ] [ Designated as safety issue: No ]
  • Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA) [ Time Frame: One month after two injections ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Anti-PhtD antibody concentration in all groups (measured by ELISA) [ Time Frame: At 12 months after the first vaccination ] [ Designated as safety issue: No ]
  • Anti-PhtD antibody avidity (measured by ELISA) [ Time Frame: At month 0, 1, 3 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767402

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767402     History of Changes
Other Study ID Numbers: 100417
Study First Received: January 10, 2013
Last Updated: January 10, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on October 29, 2014