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

NCT01767402 | Completed Phase 1

• 1 other identifier: 100417
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumococcal Disease

Keywords

Safety; Pneumococcal Infections; Immunogenicity; PhtD vaccine; Healthy adults; Reactogenicity

Outcome Measures

Primary Outcomes (5)

• Occurrence, intensity and relationship of any solicited local and general signs and symptoms

  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

  During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose

• Occurrence of all serious adverse events (SAEs)

  During the 12 months of the study

• Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)

  One month after the first injection

• Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)

  One month after two injections

Secondary Outcomes (10)

• Number and percentage of subjects with normal or abnormal values, for biochemical assessments and for hematological analysis

  At month 0, 1, 3 and 12

• Anti-PhtD antibody concentration in all groups (measured by ELISA)

  At 12 months after the first vaccination

• Anti-PhtD antibody avidity (measured by ELISA)

  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)

  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)

  At month 0, 3 and 12

Study Arms (6)

PhtD Group 1

EXPERIMENTAL

Subjects will receive PhtD vaccine formulation 1 without any adjuvant.

Biological: PhtD vaccine with/without adjuvant

PhtD Group 2

EXPERIMENTAL

Subjects will receive adjuvanted PhtD vaccine formulation 2.

Biological: PhtD vaccine with/without adjuvant

PhtD Group 3

EXPERIMENTAL

Subjects will receive adjuvanted PhtD vaccine formulation 3.

Biological: PhtD vaccine with/without adjuvant

PhtD Group 4

EXPERIMENTAL

Subjects will receive adjuvanted PhtD vaccine formulation 4.

Biological: PhtD vaccine with/without adjuvant

PhtD Group 5

EXPERIMENTAL

Subjects will receive adjuvanted PhtD vaccine formulation 5.

Biological: PhtD vaccine with/without adjuvant

23 PPV Group

ACTIVE COMPARATOR

Subjects will receive the Pneumovax 23TM vaccine and NaCl.

Biological: Pneumovax 23TM; Biological: NaCl

Interventions

PhtD vaccine with/without adjuvant BIOLOGICAL

Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.

PhtD Group 1; PhtD Group 2; PhtD Group 3; PhtD Group 4; PhtD Group 5

Pneumovax 23TM BIOLOGICAL

One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.

23 PPV Group

NaCl BIOLOGICAL

One dose administered intramuscularly in the deltoid region of the right arm at month 2.

23 PPV Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Brussels, 1200, Belgium

Location

Related Publications (1)

• Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29.

  PMID: 24176494 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: October 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

BE (1)