Ricin PoisoningPhase 1NCT02385825

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

A Phase 1 study testing RVEc in people with Ricin Poisoning, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Ricin Poisoning
What is being tested?: RVEc
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Dec 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Clinical Research, USAMRIID
Fort Deterick, Maryland, 21702

Other trials in United States

About this study

Official title: 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.

Conditions: Ricin Poisoning
Being tested: RVEc

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RVEcBiological
Also called Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine
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.

Study groups in NCT02385825
Study group	Role	What they receive
Group 1: 10 μg RVEc	Experimental	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). Receives: Biological: RVEc
Group 2: 50 μg RVEc	Experimental	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). Receives: Biological: RVEc
Group 3: 75 μg RVEc	Experimental	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). Receives: Biological: RVEc

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of vaccinated subjects without adverse events by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Measured: Day 730
Percentage of vaccinated subjects with adverse events by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Measured: Day 730
Percentage of vaccinated subjects with any severity of local reactions (Grades 1-4) by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Measured: Day 730
Percentage of vaccinated subjects with systemic reactions of any severity (Grades 1-4) by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Measured: Day 730
Percentage of vaccinated subjects with generalized allergic reactions by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Measured: Day 730
Percentage of vaccinated subjects with each adverse event by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Measured: Day 730

Secondary outcomes (2)

Total anti-ricin immunoglobulin G (IgG) antibody titers as determined by ELISA at each time point
Measured: 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)
Measured: Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Dec 2017

First posted11 Mar 2015 (estimated)
Study startApr 2016
Primary completionJun 2017 (estimated)
Study completionDec 2017 (estimated)

Why it stopped: lack of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ricin PoisoningStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02385825
Sponsor's protocol ID: S-14-03
Other IDs: FY14-01
Status last verified: Dec 2019
First submitted: 26 Feb 2015
Last updated: 2 Jan 2020
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02385825
Acronym / sponsor ID: S-14-03
Conditions: Ricin Poisoning
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: lack of funding
Enrolment: 0 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: US Army Medical Research Institute of Infectious Diseases
Study start: Apr 2016
Primary completion: Jun 2017 (estimated)
Study completion: Dec 2017 (estimated)
First posted: 11 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1: 10 μg RVEc	Experimental	Biological: RVEc10 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).
Group 2: 50 μg RVEc	Experimental	Biological: RVEc50 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).
Group 3: 75 μg RVEc	Experimental	Biological: RVEc75 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).

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (10 listed)

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..

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RVEcAlso: Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccineThe 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.	Biological	Group 1: 10 μg RVEc, Group 2: 50 μg RVEc, Group 3: 75 μg RVEc

Primary outcome

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.
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.
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.
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.
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.
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.

2 secondary outcomes

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
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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Phillip R Pittman, MD, MPH principal investigator

US Army Medical Research Institute of Infectious Diseases

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RVEc in people with Ricin Poisoning, run by U.S. Army Medical Research and Development Command at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of vaccinated subjects without adverse events by Day 730 (time frame: Day 730). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02385825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.