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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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