Possible occupational exposure to anthrax spores Infections and Infestations Anthrax
Conditions
Interventions
Generic drug name: Anthrax Vaccine Precipitated (AVP).
Dosage: One 0.5 mL dose of Anthrax Vaccine suspension for injection which contained not less than 0.125 mL of anthrax antigens.
Sponsors
Defence Science and Technology Laboratory (Dstl)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 60 years (inclusive) 2. Had, 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 had subsequently received one or more booster vaccinations could also be included 3. Eligibility to enter one of the following groups: 3.1. 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) 3.2. Group B: delayed booster recipients (subjects who had not received a dose of AVP for at least two years). 4. Ability to communicate well with the investigator and to comply with the requirements of the study 5. Females of childbearing potential had to have a negative urinary pregnancy test at screening 6. Females of child-bearing potential had to use a reliable method of contraception (as agreed at the investigator’s discretion) and agree to continue to do so from the screening visit until four weeks after the vaccination
Exclusion criteria
Exclusion criteria: 1. Presence of any clinically significant medical condition as determined by the investigator 2. Any clinically significant haematological or biochemical abnormality 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 was considered that such findings would not affect the immune response to vaccination 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 regular alcohol 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. In the opinion of the investigator, had not received a satisfactory primary series of AVP vaccination (usually 0, 3, 6 and 32 weeks) 9. Received any other vaccination in the three weeks prior to dosing, or who required any vaccination within four weeks of the AVP vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune response is measured using analysis of blood sample at several time points up to 4 months after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability is measured using injection site assessments (conducted before, 30 minutes after dosing, and on days 8, 15, 29 and 120 after dosing.) Adverse events were checked on days 3, 8, 15, 29 after dosing. End of study visit included medical examination, vital signs and ECG. 2. Information on correlate of protection against anthrax was obtained from antibody levels from blood samples taken before dosing and on days 8, 15, 29, and 120 post- booster dose. | — |
Countries
United Kingdom
Outcome results
None listed