Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
This trial is active, not recruiting.
|Condition||focus: ricin vaccine for safety and immuogenicity outcome|
|Sponsor||U.S. Army Medical Research and Materiel Command|
|Start date||March 2011|
|End date||March 2014|
|Trial size||30 participants|
|Trial identifier||NCT01317667, S-10-0002, FY09-03, A-16390|
This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine.
The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA IgG titers greater than or equal to 1:500 and TNA anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
The nature, severity, relationship to vaccine, treatment or intervention offered if any, resolution or outcome, and frequency of adverse events (AE) for the assessment population (all subjects receiving one or more vaccinations under this protocol).
time frame: Subjects will be followed for safety for 7 months after the last dose of the vaccine; SAEs for duration for study
Total anti-ricin IgG antibody titers as determined by the enzyme-linked immunosorbent assay (ELISA) and anti-ricin toxin-neutralizing antibody titers as determined by the colorimetric toxin neutralization assay (TNA) at all specified time points.
time frame: Time points include: 7, 14, and 28 days after each vaccination, 6 months, the 9-month close-out evaluation, and 12 months
Male or female participants from 18 years up to 50 years old.
Inclusion Criteria: - Study subjects must be 18-50 years old. - Subjects must weigh at least 110 pounds. - Subjects must be in good health as judged from medical history, physical examination, EKG and chest x-ray, complete blood count (CBC) with differential, clinical chemistries, urinalysis, hepatitis serology, and HIV antibody test, and be medically cleared for participation by an investigator. If any HIV or hepatitis testing is positive, the individual will be provided with counseling and referral for health care. - Females of childbearing potential must have a negative pregnancy test on vaccination day before each dose and agree to not become pregnant or breastfeed for 3 months after the last dose of the vaccine and be willing to use a reliable form of contraception during the study. - Study subjects must read and sign an approved informed consent. - Study subjects must be willing to complete a subject diary card after each vaccination. - Study subjects must be willing to return for all follow-up visits. - Study subjects must agree to report any AE that may or may not be associated with administration of the investigational product through the 9-month follow-up visit. Study subjects will report all serious adverse events for the duration of the study. Exclusion Criteria: - Body weight less than 110 pounds. - 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. - Severe hypersensitivity to any vaccine (anaphylaxis, angioedema, bronchospasm, or laryngospasm). - History of asthma, chronic obstructive pulmonary disease, or other current/residual disease of the lungs. - Clinically significant abnormal laboratory tests. - Current smoker. - Any known allergies to sodium succinate, Tween-20 (a detergent), aluminum hydroxide, or kanamycin. - Previously received ricin toxin vaccine or has antibodies to ricin toxin proteins. - Receipt of licensed vaccines within 30 days prior to the start of the study or plans to receive other vaccines during the initial 9 months of the study (the only exceptions are the inactivated influenza vaccine that can be received at least 30 days after RVEc Dose 3). - Receipt of investigational drug/test product within 30 days prior to entry or within the initial 9 months of the study. - Females: Pregnant or breastfeeding. - Enrolled in another greater than minimal risk study.
|Official title||Phase 1 Escalating, Multiple-Dose Study to Evaluate the Safety and Immunogenicity of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Healthy Adults|
|Principal investigator||Ronald Reisler, MD|
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