Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)

This study has been completed.
Sponsor:
Collaborator:
United States Army Medical Research Institute of Infectious Diseases
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01317667
First received: March 9, 2011
Last updated: January 26, 2015
Last verified: January 2015
  Purpose

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 immunoglobulin G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA) anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.


Condition Intervention Phase
Ricin
Biological: RVEc
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Number of Vaccinated Subjects Any Averse Events and by Location and Severity [ Time Frame: Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Over Response Rates and Comparisons for ELISA and TNA Titers [ Time Frame: Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12 ] [ Designated as safety issue: No ]
    Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion.


Enrollment: 30
Study Start Date: March 2011
Study Completion Date: December 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
RVEc vaccine 20 μg/dose x 3 doses
Biological: RVEc
Other Name: Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine
Experimental: Group 2
RVEc vaccine 50 μg/dose x 3 doses
Biological: RVEc
Other Name: Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine
Experimental: Group 3
RVEc vaccine 100 μg/dose x 1 dose
Biological: RVEc
Other Name: Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 adverse event (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. 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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317667

Locations
United States, Maryland
Department of Clinical Research, U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
United States Army Medical Research Institute of Infectious Diseases
Investigators
Principal Investigator: Phillip R Pittman, MD, MPH United States Army Medical Research Institute of Infectious Diseases
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01317667     History of Changes
Other Study ID Numbers: S-10-0002, FY09-03, A-16390
Study First Received: March 9, 2011
Results First Received: January 26, 2015
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Ricin
RVEc

ClinicalTrials.gov processed this record on July 05, 2015