Pneumococcal DiseasePhase 1NCT01767402
Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults
A Phase 1 study testing PhtD vaccine with/without adjuvant, Pneumovax 23TM and NaCl in people with Pneumococcal Disease, run by GlaxoSmithKline at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- PhtD vaccine with/without adjuvant, Pneumovax 23TM and NaCl
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2003to Nov 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pneumococcal Disease
- Being tested
- PhtD vaccine with/without adjuvant, Pneumovax 23TM, NaCl
- Keywords
- Safety, Pneumococcal Infections, Immunogenicity, PhtD vaccine, Healthy adults, Reactogenicity
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhtD vaccine with/without adjuvantBiological
Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Pneumovax 23TMBiological
One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
NaClBiological
One dose administered intramuscularly in the deltoid region of the right arm at month 2.
| Study group | Role | What they receive |
|---|---|---|
| PhtD Group 1 | Experimental | Subjects will receive PhtD vaccine formulation 1 without any adjuvant. Receives: Biological: PhtD vaccine with/without adjuvant |
| PhtD Group 2 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 2. Receives: Biological: PhtD vaccine with/without adjuvant |
| PhtD Group 3 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 3. Receives: Biological: PhtD vaccine with/without adjuvant |
| PhtD Group 4 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 4. Receives: Biological: PhtD vaccine with/without adjuvant |
| PhtD Group 5 | Experimental | Subjects will receive adjuvanted PhtD vaccine formulation 5. Receives: Biological: PhtD vaccine with/without adjuvant |
| 23 PPV Group | Active comparator | Subjects will receive the Pneumovax 23TM vaccine and NaCl. Receives: Biological: Pneumovax 23TM; Biological: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship of any solicited local and general signs and symptoms
Measured: 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
Measured: During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose
Occurrence of all serious adverse events (SAEs)
Measured: During the 12 months of the study
Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
Measured: One month after the first injection
Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
Measured: 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
Measured: At month 0, 1, 3 and 12
Anti-PhtD antibody concentration in all groups (measured by ELISA)
Measured: At 12 months after the first vaccination
Anti-PhtD antibody avidity (measured by ELISA)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At Day 0, 1, 60 and 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startOct 2003
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767402
- Sponsor's protocol ID
- 100417
- Status last verified
- Jan 2013
- First submitted
- 10 Jan 2013
- Last updated
- 14 Jan 2013
- Results posted
- No
Publications
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.
PubMed 24176494
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01767402
- Acronym / sponsor ID
- 100417
- Conditions
- Pneumococcal Disease
- Keywords
- Safety, Pneumococcal Infections, Immunogenicity, PhtD vaccine, Healthy adults, Reactogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PhtD Group 1 | Experimental | Biological: PhtD vaccine with/without adjuvantSubjects will receive PhtD vaccine formulation 1 without any adjuvant. |
| PhtD Group 2 | Experimental | Biological: PhtD vaccine with/without adjuvantSubjects will receive adjuvanted PhtD vaccine formulation 2. |
| PhtD Group 3 | Experimental | Biological: PhtD vaccine with/without adjuvantSubjects will receive adjuvanted PhtD vaccine formulation 3. |
| PhtD Group 4 | Experimental | Biological: PhtD vaccine with/without adjuvantSubjects will receive adjuvanted PhtD vaccine formulation 4. |
| PhtD Group 5 | Experimental | Biological: PhtD vaccine with/without adjuvantSubjects will receive adjuvanted PhtD vaccine formulation 5. |
| 23 PPV Group | Active comparator | Biological: Pneumovax 23TM, Biological: NaClSubjects will receive the Pneumovax 23TM vaccine and NaCl. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhtD vaccine with/without adjuvantTwo doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2. | Biological | PhtD Group 1, PhtD Group 2, PhtD Group 3, PhtD Group 4, PhtD Group 5 |
| Pneumovax 23TMOne dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0. | Biological | 23 PPV Group |
| NaClOne dose administered intramuscularly in the deltoid region of the right arm at month 2. | Biological | 23 PPV Group |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
- Derived from this study: PubMed 24176494Leroux-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PhtD vaccine with/without adjuvant, Pneumovax 23TM and NaCl in people with Pneumococcal Disease, run by GlaxoSmithKline at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.