Pneumococcal Infection Clinical Trial
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.
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
United Kingdom | Simbec Research Ltd | Merthyr Tydfil | Glamorgan |
Lead Sponsor | Collaborator |
---|---|
ImmunoBiology Limited | ORION Clinical Services, Oxford Therapeutics Consulting Limited, Simbec Research |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measurement of antibody production against specific pneumococcal proteins. | Exploratory analyses measuring change from baseline in serum IgG against nine pneumococcal antigens by electrochemiluminescence detection in an immunoassay. | Baseline to Day 85 | No |
Other | Measurement of the percentage inhibition by serum of the haemolytic activity of pneumolysin. | Exploratory assay to determine the ability of antibodies in serum to neutralise the haemolytic activity of pneumolysin. | Baseline to Day 85 | No |
Other | Measurement of IL-17 production following stimulation of peripheral blood mononuclear cells with PnuBioVax. | Exploratory analysis to measure the ability of peripheral blood mononuclear cells to produce IL-17 following stimulation with PnuBioVax measured by ELISA and ELISPOT. | Baseline to Day 85 | No |
Other | Measurement of the opsonophaocytic activity of serum antibodies against a target panel of S. pneumoniae strains | Exploratory analysis measuring change from baseline in the percentage killing of multiple strains of S. pneumoniae using opsonophagocytic activity assays. | Baseline to Day 85 | No |
Primary | Incidence of all treatment emergent adverse events | Number of subjects with adverse events reported from first dosing to last follow up visit. | Baseline to Day 85 | Yes |
Secondary | 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. | Baseline to Day 85 | No |
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