Pneumococcal InfectionPhase 1NCT02572635
A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax
A Phase 1 study testing PnuBioVax in people with Pneumococcal Infection, run by ImmunoBiology Limited at 1 site in United Kingdom.
Trial summary
Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain. The elderly and young children are more vulnerable to these types of infections. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- PnuBioVax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Sep 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male and female subjects between 18 and 40 years of age (inclusive).
- female subjects of child bearing potential with negative pregnancy test at screening and willing to use 2 effective methods of contraception (i.e. established method of contraception plus condom, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
- male subjects willing to use 2 effective methods of contraception unless anatomically sterile, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject, from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
- subjects with a Body Mass Index (BMI) of <30 kg/m2.
- subjects with a negative urinary drugs of abuse screen determined within 28 days of the first dose.
- subjects with negative HIV and Hepatitis B and C results.
- subjects must be willing and able to comply with the requirements of the protocol and must be available to complete the trial, including all follow up visits.
- subject must provide written informed consent to participate in the trial.
Who cannot join
- any relevant abnormality in medical history examination, vital signs laboratory tests or ECG.
- any reason that would make the assessment of any injection site reaction difficult (e.g. tattoos at injections site, black skin).
- history of migraine or asthma (no inhaler use for 5 years).
- proven diagnosis of pneumonia within last 5 years.
- current smokers.
- history of anaphylaxis or hypersensitivity to previous vaccinations.
Show all 12Show fewer
- known impairment of the immune system or chronic diseases, e.g. autoimmune diseases, diabetes, cancer.
- anticipation that the subject may require any other vaccination during the trial period.
- subjects who are antinuclear antibody (ANA) positive (above a titre of 1:80).
- subjects with haemoglobin level < 8.4 mmol/ L (males) and <7.8 mmol/L (females).
- palpable cervical or axillary lymph nodes.
- receipt of regular prescribed medication within 28 days of the first trial day and / or receipt of vitamins, minerals, herbal remedies and nutritional supplements within 7 days of the first trial day.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Ltd
Merthyr Tydfil, Glamorgan, CF48 4DR
About this study
Official title: A Randomised, Placebo Controlled, Double-blind, Dose Escalation, Single Centre Trial to Evaluate the Safety and Immunogenicity of PnuBioVax Administered on Three Occasions 28 Days Apart at Three Dose Levels in Healthy Adult Subjects.
Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain. The elderly and young children are more vulnerable to these types of infections.
The vaccines available at present are effective only on a certain number of strains of the bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains. This study will be looking at the safety and tolerability of the study drug for three different dosages: 50 μg, 200 μg, and 500 μg compared to placebo.
Read more
The population eligible to take part in the study are healthy male and female subjects between 18 and 40 years of age.
Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Only subjects who agree to undertake precautions to avoid pregnancy of either themselves of their partner during the study period will be eligible. Volunteers will give signed consent for their physician to be notified about their participation in the trial.
Read the detailed description
This is a phase I study to assess the safety and immunogenicity of PnuBioVax administered on three occasions 28 days apart at dose levels of 50 µg, 200 µg, and 500 µg in healthy adult subjects.
The study will involve 8 visits in total; screening period to determine eligibility, 3 treatment periods comprising of an overnight stay at the clinic (days 1, 29 and 57) and 4 outpatient follow up visits (7 days after each dosing period and one on day 85). Volunteers will also be requested to complete a diary card from day 1 to day 85.
36 Volunteers will take part in this study and will be randomly assigned to each sequential dose group as follows:
- Cohort 1: up to 3 doses of 50 µg of PnuBioVax or placebo
- Cohort 2: up to 3 doses of 200 µg of PnuBioVax or placebo
- Cohort 3: up to 3 doses of 500 µg of PnuBioVax or placebo Within each cohort, nine subjects will receive PnuBioVax and three subjects will receive placebo. Each subject will receive administrations of PnuBioVax or placebo on Days 1, 29 and 57.
The lowest dose of PnuBioVax will be evaluated first (i.e. Cohort 1). Dose escalation will only proceed in the subsequent cohorts if blinded safety data (adverse events, injection site reactions, concomitant medication, vital signs and routine laboratory assessments) from day 8 from the 12 subjects in the preceding cohort have been reviewed by the Sponsor and Principal Investigator and are found to be satisfactory. The Sponsor and Principal Investigator will also review the safety data after each subsequent dose to ensure repeat dosing does not give rise to safety issues.
Subjects will be followed up 7 days after each vaccination and also by telephone 14 and 21 days following each vaccination. Subjects will also be requested to record any adverse events in a daily diary. Haematology, biochemistry and vital signs will be measured at each follow up visit (except day 85) and a full safety follow up will be completed 7 days after the third dose (day 64).
Bloods will be drawn for evaluation of the immune response to the PnuBioVax, 28 days following the first, second and third administrations (Days 29, 57 and 85). The blood draw at day 85 will also be used for exploratory analyses.
The presence of autoantibodies will be assessed at screening (baseline level), and day 85 by measurement of anti nuclear antibody (ANA) levels.
- Conditions
- Pneumococcal Infection
- Being tested
- PnuBioVax, Placebo
- Keywords
- Pneumococcal Infection, Phase I, Immunogenicity, Safety, Vaccination
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PnuBioVaxBiological
Three administrations (by intramuscular injection) given 28 days apart to 9 subjects.
PlaceboBiological
Placebo administered by intramuscular injection to 3 subjects in each cohort. Three administrations given 28 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 50 µg of PnuBioVax Receives: Biological: PnuBioVax |
| Cohort 2 | Experimental | 200 µg of PnuBioVax Receives: Biological: PnuBioVax |
| Cohort 3 | Experimental | 500 µg of PnuBioVax Receives: Biological: PnuBioVax |
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all treatment emergent adverse events
Number of subjects with adverse events reported from first dosing to last follow up visit.
Measured: Baseline to Day 85
Secondary outcomes (1)
The proportion of subjects who develop an immune response to PnuBioVax
The proportion of subjects with an increase in serum IgG specific for PnuBioVax measured by ELISA on Days 1 (baseline), 29, 57 and 85.
Measured: Baseline to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
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 InfectionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoBiology Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research, Oxford Therapeutics Consulting Limited, ORION Clinical Services
- Responsible party
- Sponsor
- Investigators
- Christopher Bailey, Bsc, PhD, Study director, Sponsor (ImmunoBiology Ltd)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572635
- Sponsor's protocol ID
- SPV-001
- Other IDs
- 2015-002986-51, 2015
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Entwisle C, Hill S, Pang Y, Joachim M, McIlgorm A, Colaco C, Goldblatt D, De Gorguette D'Argoeuves P, Bailey C. Safety and immunogenicity of a novel multiple antigen pneumococcal vaccine in adults: A Phase 1 randomised clinical trial. Vaccine. 2017 Dec 18;35(51):7181-7186. doi: 10.1016/j.vaccine.2017.10.076. Epub 2017 Nov 10.
PubMed 29132988
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled, Double-blind, Dose Escalation, Single Centre Trial to Evaluate the Safety and Immunogenicity of PnuBioVax Administered on Three Occasions 28 Days Apart at Three Dose Levels in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT02572635
- Acronym / sponsor ID
- SPV-001
- Conditions
- Pneumococcal Infection
- Keywords
- Pneumococcal Infection, Phase I, Immunogenicity, Safety, Vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ImmunoBiology LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research, Oxford Therapeutics Consulting Limited, ORION Clinical Services
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Oct 2015 (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.
Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain. The elderly and young children are more vulnerable to these types of infections.
The vaccines available at present are effective only on a certain number of strains of the bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains. This study will be looking at the safety and tolerability of the study drug for three different dosages: 50 μg, 200 μg, and 500 μg compared to placebo.
The population eligible to take part in the study are healthy male and female subjects between 18 and 40 years of age.
Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between reading the information leaflet and agreeing to participate. Only subjects who agree to undertake precautions to avoid pregnancy of either themselves of their partner during the study period will be eligible. Volunteers will give signed consent for their physician to be notified about their participation in the trial.
Detailed description
This is a phase I study to assess the safety and immunogenicity of PnuBioVax administered on three occasions 28 days apart at dose levels of 50 µg, 200 µg, and 500 µg in healthy adult subjects.
The study will involve 8 visits in total; screening period to determine eligibility, 3 treatment periods comprising of an overnight stay at the clinic (days 1, 29 and 57) and 4 outpatient follow up visits (7 days after each dosing period and one on day 85). Volunteers will also be requested to complete a diary card from day 1 to day 85.
36 Volunteers will take part in this study and will be randomly assigned to each sequential dose group as follows:
- Cohort 1: up to 3 doses of 50 µg of PnuBioVax or placebo
- Cohort 2: up to 3 doses of 200 µg of PnuBioVax or placebo
- Cohort 3: up to 3 doses of 500 µg of PnuBioVax or placebo Within each cohort, nine subjects will receive PnuBioVax and three subjects will receive placebo. Each subject will receive administrations of PnuBioVax or placebo on Days 1, 29 and 57.
The lowest dose of PnuBioVax will be evaluated first (i.e. Cohort 1). Dose escalation will only proceed in the subsequent cohorts if blinded safety data (adverse events, injection site reactions, concomitant medication, vital signs and routine laboratory assessments) from day 8 from the 12 subjects in the preceding cohort have been reviewed by the Sponsor and Principal Investigator and are found to be satisfactory. The Sponsor and Principal Investigator will also review the safety data after each subsequent dose to ensure repeat dosing does not give rise to safety issues.
Subjects will be followed up 7 days after each vaccination and also by telephone 14 and 21 days following each vaccination. Subjects will also be requested to record any adverse events in a daily diary. Haematology, biochemistry and vital signs will be measured at each follow up visit (except day 85) and a full safety follow up will be completed 7 days after the third dose (day 64).
Bloods will be drawn for evaluation of the immune response to the PnuBioVax, 28 days following the first, second and third administrations (Days 29, 57 and 85). The blood draw at day 85 will also be used for exploratory analyses.
The presence of autoantibodies will be assessed at screening (baseline level), and day 85 by measurement of anti nuclear antibody (ANA) levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: PnuBioVax50 µg of PnuBioVax |
| Cohort 2 | Experimental | Biological: PnuBioVax200 µg of PnuBioVax |
| Cohort 3 | Experimental | Biological: PnuBioVax500 µg of PnuBioVax |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- healthy male and female subjects between 18 and 40 years of age (inclusive).
- female subjects of child bearing potential with negative pregnancy test at screening and willing to use 2 effective methods of contraception (i.e. established method of contraception plus condom, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
- male subjects willing to use 2 effective methods of contraception unless anatomically sterile, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject, from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
- subjects with a Body Mass Index (BMI) of <30 kg/m2.
- subjects with a negative urinary drugs of abuse screen determined within 28 days of the first dose.
Key exclusion criteria (12 listed)
- any relevant abnormality in medical history examination, vital signs laboratory tests or ECG.
- any reason that would make the assessment of any injection site reaction difficult (e.g. tattoos at injections site, black skin).
- history of migraine or asthma (no inhaler use for 5 years).
- proven diagnosis of pneumonia within last 5 years.
- current smokers.
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 |
|---|---|---|
| PnuBioVaxThree administrations (by intramuscular injection) given 28 days apart to 9 subjects. | Biological | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboPlacebo administered by intramuscular injection to 3 subjects in each cohort. Three administrations given 28 days apart. | Biological | Placebo |
Primary outcome
Incidence of all treatment emergent adverse events
Time frame: Baseline to Day 85
Number of subjects with adverse events reported from first dosing to last follow up visit.
1 secondary outcome
The proportion of subjects who develop an immune response to PnuBioVax
Time frame: Baseline to Day 85
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 5 Oct 2016.
- Derived from this study: PubMed 29132988Entwisle C, Hill S, Pang Y, Joachim M, McIlgorm A, Colaco C, Goldblatt D, De Gorguette D'Argoeuves P, Bailey C. Safety and immunogenicity of a novel multiple antigen pneumococcal vaccine in adults: A Phase 1 randomised clinical trial. Vaccine. 2017 Dec 18;35(51):7181-7186. doi: 10.1016/j.vaccine.2017.10.076. Epub 2017 Nov 10.
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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.
Christopher Bailey, Bsc, PhD study director
Sponsor (ImmunoBiology Ltd)
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 PnuBioVax in people with Pneumococcal Infection, run by ImmunoBiology Limited at 1 site in United Kingdom.
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 8 inclusion and 12 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 5 Oct 2016. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Incidence of all treatment emergent adverse events (time frame: Baseline to Day 85). 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 NCT02572635, 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 5 Oct 2016.