Army starts clinical trials on ricin vaccine

Percentage of vaccinated subjects with each adverse event by Day [ Time Frame: Day ] Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details.

Last Update Posted : January 2, Study Description. This study is evaluating if RVEc will display an acceptable safety profile as determined by adverse event AE data and if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine recipients. FDA Resources. It is also deadly when swallowed. A British white supremacist pleaded guilty last year to producing ricin and preparing for acts of terrorism. Baltimore News.

Sean Yoder also had 9 points. Study participants must be willing to return for all follow-up visits. Study participants must agree to report any adverse events AE that may or may not be associated with administration of the investigational product through duration of study participation. Study participants must agree to abstain from excessive exercise more than the usual routine and excessive alcohol consumption exceeds 2 drinks for males or exceeds 1 drink for females daily or binge drinking for the duration of study participation.

Exclusion Criteria: Acute or chronic medical conditions or immunodeficiency from a medical condition or medical treatment, medications, or dietary supplements that, in the investigator's opinion, would impair the subject's ability to respond to vaccination.

Use of corticosteroids, other than inhaled or topical corticosteroids or eye drops, will not be permitted. Severe hypersensitivity to any vaccine. Clinically significant abnormal laboratory tests. Current smoker, to include use of electronic cigarettes.. Any known allergies to sodium succinate, Polysorbate 20 a detergent , Alhydrogel, or kanamycin.

Receipt of any vaccine or investigational product within 30 days before or after vaccination with RVEc the only exception is the inactivated influenza vaccine that can be received at least 30 days after RVEc Dose 3 or 4. For this Phase 1 study, we will not administer product to subjects with bilateral shoulder injuries.

Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Layout table for additonal information Responsible Party: U. National Library of Medicine U. Based on these results, we have now conducted a pilot clinical trial in humans under an investigational new drug application submitted to the Food and Drug Administration.

In this study, three groups of five normal volunteers were injected three times at monthly intervals with 10, 33, or mug of RiVax.