Ricin PoisoningPhase 1RVEcNCT01846104
Booster Dose (50 µg) of Recombinant Ricin Toxin Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
A Phase 1 study testing 50-μg booster dose RVEc in people with Ricin Poisoning, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg doses of RVEc in a Phase 1 trial (NCT01317667). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ricin Poisoning
- What is being tested?
- 50-μg booster dose RVEc
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2013to 30 Jun 2013
- 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 have received the 3 priming doses of RVEc at the 50-µg dosage.
- Study subjects must be 18 years old at time of screening and no older than 50 years old at time of vaccination.
- Subjects must weigh at least 110 pounds at time of screening.
- Subjects must be in good health as judged from medical history, physical examination, EKG, hematology, clinical chemistries, urinalysis, hepatitis serology, and HIV antibody test (Table 4) 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 child-bearing potential must have a negative pregnancy test on screening and the morning of vaccination prior to receipt of the vaccine and must agree to use a highly effective method of birth control during the first 3 months following receipt of RVEc. 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 (Norplant, Depo-Provera, Lunelle, and Etonogestrel), combined oral contraceptives, the intrauterine devices (IUDs) Copper T (380-A) or Mirena (Levonorgestrel Intrauterine System), female sterilization (tubal ligation), sexual abstinence, or a vasectomized partner.
- Female subjects must also agree not to breastfeed until at least 3 months after receiving the RVEc.
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- Study subjects must read and sign an approved informed consent.
- 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 6-month follow-up/closeout visit.
- Study subjects must agree to abstain from excessive exercise (more than the usual routine) and excessive alcohol consumption (exceeds more than 2 drinks for males or 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 corticosteroids, will not be permitted.
- Severe hypersensitivity to any vaccine (anaphylaxis, angioedema, bronchospasm, or laryngospasm).
- History of asthma, chronic obstructive pulmonary disease, or other current/residual diseases of the lungs.
- Clinically significant abnormal laboratory tests.
- Current smoker.
- Any known allergies to sodium succinate, Tween-20 (a detergent), aluminum hydroxide, or kanamycin.
- Receipt of any vaccine or investigational product within 30 days before or after vaccination with RVEc.
- Receipt of RVEc is contraindicated based on SIRVA checklist/screening, as determined by PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Clinical Research, USAMRIID
Frederick, Maryland, 21702
About this study
Official title: Safety and Immunogenicity of a Booster Dose (50 µg) of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg doses of RVEc in a Phase 1 trial (NCT01317667).
- Conditions
- Ricin Poisoning
- Being tested
- 50-μg booster dose RVEc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50-μg booster dose RVEcBiological
Also called Ricin Vaccine
Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
| Study group | Role | What they receive |
|---|---|---|
| 50-μg booster dose RVEc | Experimental | Subjects will be receive one 50-μg dose of RVEc Receives: Biological: 50-μg booster dose RVEc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Measured: Six months
Secondary outcomes (2)
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Measured: Six months
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start30 Apr 2013
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew S Chambers, MD, MPH, Principal investigator, USAMRIID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846104
- Sponsor's protocol ID
- S-12-23
- Other IDs
- FY12-16
- Acronym
- RVEc
- Status last verified
- Dec 2019
- First submitted
- 30 Apr 2013
- Last updated
- 27 Dec 2019
- 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 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Booster Dose (50 µg) of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
- ClinicalTrials.gov ID
- NCT01846104
- Acronym / sponsor ID
- RVEc / S-12-23
- Conditions
- Ricin Poisoning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 30 Apr 2013 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg doses of RVEc in a Phase 1 trial (NCT01317667).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50-μg booster dose RVEc | Experimental | Biological: 50-μg booster dose RVEcSubjects will be receive one 50-μg dose of RVEc |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Study subjects must have received the 3 priming doses of RVEc at the 50-µg dosage.
- Study subjects must be 18 years old at time of screening and no older than 50 years old at time of vaccination.
- Subjects must weigh at least 110 pounds at time of screening.
- Subjects must be in good health as judged from medical history, physical examination, EKG, hematology, clinical chemistries, urinalysis, hepatitis serology, and HIV antibody test (Table 4) 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 child-bearing potential must have a negative pregnancy test on screening and the morning of vaccination prior to receipt of the vaccine and must agree to use a highly effective method of birth control during the first 3 months following receipt of RVEc. 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 (Norplant, Depo-Provera, Lunelle, and Etonogestrel), combined oral contraceptives, the intrauterine devices (IUDs) Copper T (380-A) or Mirena (Levonorgestrel Intrauterine System), female sterilization (tubal ligation), sexual abstinence, or a vasectomized partner.
Key exclusion criteria (8 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 corticosteroids, will not be permitted.
- Severe hypersensitivity to any vaccine (anaphylaxis, angioedema, bronchospasm, or laryngospasm).
- History of asthma, chronic obstructive pulmonary disease, or other current/residual diseases of the lungs.
- Clinically significant abnormal laboratory tests.
- Current smoker.
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 |
|---|---|---|
| 50-μg booster dose RVEcAlso: Ricin VaccineSubjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination. | Biological | 50-μg booster dose RVEc |
Primary outcome
Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.
Time frame: Six months
2 secondary outcomes
Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)
Time frame: Six months
Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- 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.
Matthew S Chambers, MD, MPH principal investigator
USAMRIID
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 50-μg booster dose 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 10 inclusion and 8 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 27 Dec 2019. 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 21 Nov 2016). 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 Participants Who Experienced Adverse Events by Nature and Severity. (time frame: Six 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 NCT01846104, 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 27 Dec 2019.