IM Recombinant Ricin Toxin Vaccine (RVEc) - 3-Dose Primary Series With Boost

December 30, 2019 updated by: U.S. Army Medical Research and Development Command

Phase 1b Escalating Study to Evaluate the Safety and Immunogenicity of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) Administered Intramuscularly to Healthy Adults as a 3-Dose Primary Series and Booster

This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Fort Deterick, Maryland, United States, 21702
        • Department of Clinical Research, USAMRIID

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Study participants must read and sign an approved informed consent.
  • Study participants must be at least 18 years old at time of screening and no older than 50 years old at time of first study vaccination.
  • Participants must weigh at least 110 pounds at time of screening.
  • Participants must be in good health as judged from medical history, physical examination, electrocardiogram, chest x-ray, hematology, clinical chemistries, urinalysis, hepatitis serology, and human immunodeficiency virus antibody test and must be medically cleared for participation by an investigator.
  • Females of childbearing potential must have a negative pregnancy test on screening and the morning of each vaccination prior to receipt of the vaccine and must agree to use a highly effective method of birth control from screening through 3 months following last study vaccination. A highly effective method of birth control is defined as one with a failure rate of less than 1% per year. Acceptable birth control methods that meet this criterion include hormonal implants and injectables, combined oral contraceptives, intrauterine devices (IUDs), female sterilization (tubal ligation), sexual abstinence, or a vasectomized partner.
  • Female participants must also agree not to breastfeed from screening through 3 months following last study vaccination.
  • 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.
  • History of asthma, chronic obstructive pulmonary disease, or other current/residual diseases of the lungs.
  • 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).
  • Receipt of RVEc is contraindicated based on shoulder injury related to vaccine administration (SIRVA) checklist/screening, as determined by principle investigator. (For this Phase 1 study, we will not administer product to subjects with bilateral shoulder injuries.)
  • Creatine phosphokinase levels that are consistently elevated more than 2 × normal
  • Previous vaccination with RVEc or any other ricin vaccine candidate by any route.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: 10 μg RVEc
10 μg RVEc is to be administered in the lower two-thirds of the deltoid region by intramuscular (IM) injection with a needle and syringe (0.5 mL/dose). There are 4 doses planned for this group: 1 primary dose on Days 0, 28, and 106, and a booster dose on Day 365 (1 year).
Biological: RVEc
The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin A-chain 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial.
Other Names:
  • Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine
Experimental: Group 2: 50 μg RVEc
50 μg RVEc is to be administered in the lower two-thirds of the deltoid region by intramuscular (IM) injection with a needle and syringe (0.5 mL/dose). There are 4 doses planned for this group: 1 primary dose on Days 0, 28, and 106, and a booster dose on Day 365 (1 year).
Biological: RVEc
The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin A-chain 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial.
Other Names:
  • Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine
Experimental: Group 3: 75 μg RVEc
75 μg RVEc is to be administered in the lower two-thirds of the deltoid region by intramuscular (IM) injection with a needle and syringe (0.5 mL/dose). There are 4 doses planned for this group: 1 primary dose on Days 0, 28, and 106, and a booster dose on Day 365 (1 year).
Biological: RVEc
The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin A-chain 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial.
Other Names:
  • Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of vaccinated subjects without adverse events by Day 730
Time Frame: Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Day 730
Percentage of vaccinated subjects with adverse events by Day 730
Time Frame: Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Day 730
Percentage of vaccinated subjects with any severity of local reactions (Grades 1-4) by Day 730
Time Frame: Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Day 730
Percentage of vaccinated subjects with systemic reactions of any severity (Grades 1-4) by Day 730
Time Frame: Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Day 730
Percentage of vaccinated subjects with generalized allergic reactions by Day 730
Time Frame: Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Day 730
Percentage of vaccinated subjects with each adverse event by Day 730
Time Frame: Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Day 730

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total anti-ricin immunoglobulin G (IgG) antibody titers as determined by ELISA at each time point
Time Frame: Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730
Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730
Anti-ricin toxin-neutralizing antibody titers as determined by the colorimetric toxin neutralization assay (TNA)
Time Frame: Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730
Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Army Medical Research and Development Command

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
US Army Medical Research Institute of Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-14-03
  • FY14-01 (Other Identifier: Human Use Committee, USAMRIID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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