Vaccination against potential exposure to anthrax (Bacillus anthracis).
Conditions
Interventions
Trade Name: Anthrax vaccine (alum precipitated sterile filtrate)
Product Code: AVP
Pharmaceutical Form: Suspension for injection
Other descriptive name: Anthrax antigens
Concentration unit: ml millili
Sponsors
Dstl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this study, subjects must meet the following criteria: 1. Ability and willingness to give written informed consent prior to study participation. 2. Healthy male and female subjects aged between 18 and 60 years (inclusive). 3. Must have, in the opinion of the Investigator, completed a satisfactory primary series of AVP vaccination (four doses usually given at 0, 3, 6 and 32 weeks); Individuals who have subsequently received one or more booster vaccinations may also be included. 4. Subjects must be eligible to enter one of the following groups: • Group A: Annual booster recipients (subjects scheduled to receive their annual booster of AVP – i.e. had their last dose 12 months +/- one month previously). • Group B: Delayed booster recipients (subjects who have not received a dose of AVP for at least two years). 5. Ability to communicate well with the Investigator and to comply with the requirements of the study. 6. Females of child bearing potential must have a negative urinary pregnancy test at screening. 7. Females of child bearing potential must be using a reliable method of contraception (as agreed at the Investigator’s discretion) and must agree to continue to do so from the screening visit until four weeks after the vaccination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from participation in the study: 1. Presence of any clinically significant medical condition as determined by the Investigator. Minor deviations outside the relevant reference range, in the absence of overt clinical disease would not exclude a subject if it is considered that such findings would not affect the immune response to vaccination. 2. Any clinically significant haematological or biochemical abnormality as determined by the Investigator. 3. Any surgical or medical condition which might significantly alter the immune response to the vaccine, as determined by the investigator. 4. Known or suspected hypersensitivity or idiosyncratic reaction related to any AVP vaccine components. 5. History or evidence of alcohol abuse defined as an intake of more than 28 units per week for men and 21 units per week for women, where 1 unit corresponds to 250 mL beer, 20 mL spirits/liqueur or one glass (100 mL) of wine. 6. Participation in another clinical trial within the three months prior to dosing. 7. Donation of blood or blood products within the three months prior to dosing, or the intention to donate blood or blood products during the course of the study. 8. Subjects who, in the opinion of the Investigator, have not received a satisfactory primary series of AVP vaccination (0, 3, 6 and 32 weeks). 9. Subjects who have received any other vaccination in the three weeks prior to dosing, or who require any vaccination within four weeks of the AVP vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate immune responses to booster doses (annual compared with delayed) of the current UK licensed anthrax vaccine (Anthrax Vaccine Precipitated (AVP)).;Secondary Objective: To evaluate the safety and tolerability of booster doses of AVP, annual compared with delayed. To obtain information on correlates of protection against anthrax, to inform the recombinant anthrax vaccine development programme.;Primary end point(s): The pharmacodynamic changes in immune response will measure blood antibody concentrations and serum toxin neutralisation assay (TNA). Blood samples will be taken up to 29 days and an additional blood sample collected after 4 months. Physical examination and laboratory safety screening will be undertaken pre-study and physical examination and symptom assessment post-study. | — |
Countries
United Kingdom
Outcome results
None listed