RicinPhase 1NCT01317667
Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
A Phase 1 study testing RVEc in people with Ricin, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ricin
- What is being tested?
- RVEc
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Clinical Research, U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702
About this 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
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.
- Conditions
- Ricin
- Being tested
- RVEc
- Keywords
- Ricin, 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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | RVEc vaccine 20 μg/dose x 3 doses Receives: Biological: RVEc |
| Group 2 | Experimental | RVEc vaccine 50 μg/dose x 3 doses Receives: Biological: RVEc |
| Group 3 | Experimental | RVEc vaccine 100 μg/dose x 1 dose Receives: Biological: RVEc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Vaccinated Subjects Any Averse Events and by Location and Severity
Measured: Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months
Secondary outcomes (1)
Over Response Rates and Comparisons for ELISA and TNA Titers
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.
Measured: Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RicinStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Phillip R Pittman, MD, MPH, Principal investigator, US Army Medical Research Institute of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317667
- Sponsor's protocol ID
- S-10-0002, FY09-03, A-16390
- Status last verified
- Dec 2019
- First submitted
- 9 Mar 2011
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pittman PR, Reisler RB, Lindsey CY, Guerena F, Rivard R, Clizbe DP, Chambers M, Norris S, Smith LA. Safety and immunogenicity of ricin vaccine, RVEc, in a Phase 1 clinical trial. Vaccine. 2015 Dec 16;33(51):7299-7306. doi: 10.1016/j.vaccine.2015.10.094. Epub 2015 Nov 3.
PubMed 26546259
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01317667
- Acronym / sponsor ID
- S-10-0002, FY09-03, A-16390
- Conditions
- Ricin
- Keywords
- Ricin, RVEc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 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
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: RVEcRVEc vaccine 20 μg/dose x 3 doses |
| Group 2 | Experimental | Biological: RVEcRVEc vaccine 50 μg/dose x 3 doses |
| Group 3 | Experimental | Biological: RVEcRVEc vaccine 100 μg/dose x 1 dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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) Vaccine | Biological | Group 1, Group 2, Group 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26546259Pittman PR, Reisler RB, Lindsey CY, Guerena F, Rivard R, Clizbe DP, Chambers M, Norris S, Smith LA. Safety and immunogenicity of ricin vaccine, RVEc, in a Phase 1 clinical trial. Vaccine. 2015 Dec 16;33(51):7299-7306. doi: 10.1016/j.vaccine.2015.10.094. Epub 2015 Nov 3.
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, 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 3 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?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). 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 NCT01317667, which also lists 1 linked publication.
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 3 Jan 2020.