A Phase 1 interventional study of PnuBioVax and Placebo in Pneumococcal Infection, sponsored by ImmunoBiology Limited. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by ImmunoBiology Limited · Phase 1, Interventional, and Other
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.
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:
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.
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 36 is below the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →This is the only study on the registry with ImmunoBiology Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 µg of PnuBioVax
Biological: PnuBioVax
200 µg of PnuBioVax
Biological: PnuBioVax
500 µg of PnuBioVax
Biological: PnuBioVax
Placebo
Biological: Placebo
Three administrations (by intramuscular injection) given 28 days apart to 9 subjects.
Placebo administered by intramuscular injection to 3 subjects in each cohort. Three administrations given 28 days apart.
Incidence of all treatment emergent adverse events
Number of subjects with adverse events reported from first dosing to last follow up visit.
Time frame: Baseline to Day 85
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.
Time frame: Baseline to Day 85
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.
Time frame: Baseline to Day 85
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.
Time frame: Baseline to Day 85
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.
Time frame: Baseline to Day 85
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.
Time frame: Baseline to Day 85
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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