Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114621
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-06-15
Brief Title:
Anthrax Vaccine Clinical Trials
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Anthrax Vaccine Clinical Trials
Status:
COMPLETED
Status Verified Date:
2012-03-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the recombinant that is produced by genetic engineering protective antigen rPA that brings about antibodies to neutralize the anthrax toxin and that could therefore be predicted to offer protection against anthrax Today anthrax is rarely encountered in the United States since the introduction of vaccines for cattle in the 1930s A human vaccine was licensed in 1970 Vaccination against anthrax has been confined to people at risk such as wool sorters and some veterinarians However the rising prospects of B anthracis being used as a weapon have led to routine administration of the anthrax vaccine to members of the armed forces
Adults who are in good health may be eligible for this study The involvement of 300 adults is planned
Participants will have a general physical exam and test for vital signs There will also be collection of blood for chemistry and hematology urinalysis tests for HIV hepatitis B and C and liver function and a pregnancy test if applicable
On a random basis patients will receive one of the rPA formulations Two doses of rPA will be evaluated 10 microgram Microg and 20 Microg This evaluation aims to establish the safety and most desirable level of dosage Patients will receive one injection of the vaccine administered in the left shoulder or left thigh About 30 minutes later their temperature will be taken and the injection site will be inspected Rare but severe reactions could occur if there is extreme sensitivity to a vaccine However such an occurrence is extremely rare following a vaccine and if there are any dangerous symptoms they can be effectively treated by medications available to patients while they are at the clinic If there are no significant abnormal results patients may return home About 6 hours later and daily for 7 days they will take their temperature and examine the injection site The vaccine may cause temporary discomfort at the site of injection and participants may experience a mild fever for 1 or 2 days after vaccination
Patients will receive diary cards a digital thermometer and instructions on taking their temperature and measuring redness and swelling at the injection site as well as for recording aches muscle pain or sensitivity to light for 7 days They will be examined at the clinic at 72 hours following vaccination and also on the 7th day if they have a fever at or above 1004 if swelling is at or more than 2 inches or if they request an exam Meanwhile a clinic staff member will call patients and discuss the findings Then patients will receive a second and third injection of the same vaccine at 2-month intervals There will also be interviews about patients health at each visit to the clinic plus monitoring of the vaccination after 6 hours and for 7 days One year later patients will receive a fourth injection of the same vaccine
Direct benefit to participants in this study is not guaranteed although an antibody response is predicted The results in this study will help in the development of improved vaccines for anthrax
Adults who are in good health may be eligible for this study The involvement of 300 adults is planned
Participants will have a general physical exam and test for vital signs There will also be collection of blood for chemistry and hematology urinalysis tests for HIV hepatitis B and C and liver function and a pregnancy test if applicable
On a random basis patients will receive one of the rPA formulations Two doses of rPA will be evaluated 10 microgram Microg and 20 Microg This evaluation aims to establish the safety and most desirable level of dosage Patients will receive one injection of the vaccine administered in the left shoulder or left thigh About 30 minutes later their temperature will be taken and the injection site will be inspected Rare but severe reactions could occur if there is extreme sensitivity to a vaccine However such an occurrence is extremely rare following a vaccine and if there are any dangerous symptoms they can be effectively treated by medications available to patients while they are at the clinic If there are no significant abnormal results patients may return home About 6 hours later and daily for 7 days they will take their temperature and examine the injection site The vaccine may cause temporary discomfort at the site of injection and participants may experience a mild fever for 1 or 2 days after vaccination
Patients will receive diary cards a digital thermometer and instructions on taking their temperature and measuring redness and swelling at the injection site as well as for recording aches muscle pain or sensitivity to light for 7 days They will be examined at the clinic at 72 hours following vaccination and also on the 7th day if they have a fever at or above 1004 if swelling is at or more than 2 inches or if they request an exam Meanwhile a clinic staff member will call patients and discuss the findings Then patients will receive a second and third injection of the same vaccine at 2-month intervals There will also be interviews about patients health at each visit to the clinic plus monitoring of the vaccination after 6 hours and for 7 days One year later patients will receive a fourth injection of the same vaccine
Direct benefit to participants in this study is not guaranteed although an antibody response is predicted The results in this study will help in the development of improved vaccines for anthrax
Detailed Description:
Anthrax is rarely encountered in the US since the introduction of attenuated vaccines for cattle in the 1930s A vaccine for humans composed of a cell-free preparation absorbed onto alum was licensed in 1970 after successful clinical trials Vaccination against anthrax in the US was confined to individuals at risk such as wool sorters and some veterinarians until the prospects were raised of B anthracis being used as a weapon after the Iraq war Now anthrax vaccine is administered routinely to the armed forces Interest in improving this vaccine was stimulated by the use of B anthracis spores for bioterrorism
The active component of the investigational vaccine is called the protective antigen When B anthracis invades the host tissues the protective antigen activates two other proteins to form anthrax toxin The symptoms of anthrax are caused by this toxin Alone the protective antigen has no known toxicity The gene for this protein has been isolated and changed specifically to improve its properties as a vaccine-this recombinant protective antigen rPA elicits antibodies that neutralize the anthrax toxin and thereby can be predicted to confer protection
This is the first study of our investigational rPA vaccine in humans The broad objectives are to characterize the safety and serum antibody levels of different doses and formulations of rPA in comparison to the licensed anthrax vaccine AVA
The active component of the investigational vaccine is called the protective antigen When B anthracis invades the host tissues the protective antigen activates two other proteins to form anthrax toxin The symptoms of anthrax are caused by this toxin Alone the protective antigen has no known toxicity The gene for this protein has been isolated and changed specifically to improve its properties as a vaccine-this recombinant protective antigen rPA elicits antibodies that neutralize the anthrax toxin and thereby can be predicted to confer protection
This is the first study of our investigational rPA vaccine in humans The broad objectives are to characterize the safety and serum antibody levels of different doses and formulations of rPA in comparison to the licensed anthrax vaccine AVA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CH-0283 | None | None | None |