Rift Valley FeverPhase 2MP-12NCT00415051
Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine
A Phase 2 study testing RVF MP-12 in people with Rift Valley Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune response (which fights off infection) and if the vaccine is stable or if the virus used to make the vaccine changes into a different form… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rift Valley Fever
- What is being tested?
- RVF MP-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to May 2009
- Phase
- Phase 2
- 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
- Between 18 and 50 years old
- Free of chronic medical conditions requiring ongoing therapy and in general good health as determined by a physician investigator
- Have a current (within 30 days of scheduled blood donation for this study) complete blood (cell) count (CBC) to include a Hct and Hgb that show no evidence of anemia, and total white blood cell with differential platelet counts that are within normal range, as well as hepatic enzyme (AST, ALT, LDH) values that are within normal laboratory ranges
- Negative human immunodeficiency virus (HIV) antibody test within 3 months preceding vaccination
- No evidence of pre-existing liver disease or current infection with Hepatitis A, B, or C virus as determined by serology
- No evidence for pre-existing eye disease, as determined by fundoscopic/slit lamp examination by the study ophthalmologist other than refractory changes
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- No evidence by history or serologic testing for previous infection with RVF virus or RVF vaccine
- Subjects must agree to refrain from intimate contact (sexual activity), or use barrier contraception (e.g., condoms), for the 2-week period following vaccination
- Females of child-bearing potential must have a negative serum 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 the MP-12 vaccine. 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, Dep-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.
- Subjects must be medically cleared for participation by an investigator
- Subjects must expect to remain in the area for the duration of the study
- Volunteer must sign an approved informed consent
- Volunteer must be willing to return for all follow-up visits including a post-vaccination ophthalmologic visit
- Volunteer must be willing to refrain from excessive (more than individual's normal routine) exercise for a period of at least 2 weeks prior to and following vaccination
- Volunteer must be willing to abstain from drinking alcoholic beverages for a period of at least 2 weeks prior to and following vaccination. Volunteer must not be a "weekend" drinker or normally drink more than 2 drinks a day if male or 1 drink a day if female.
- Volunteer must agree to report any adverse event (AE) that may or may not be associated with administration of the test article during their participation in the study.
Who cannot join
- History or evidence of liver disease/abnormality
- History of pre-existing thymic disease or thymic dysfunction (any cellular immune or antibody disorders)
- Be taking any medication, prescription or non-prescription (excluding dietary supplements), on a regular basis with the exception of contraceptive pills. This includes the regular use of statins, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, antivirals, topical steroidal creams, and nasal sprays. Conditions requiring intermittent medications and other decisions regarding eligibility due to medication use will be deferred to physician investigators.
- Elevation above the upper limit of laboratory normal values in liver enzymes, or history of unexplained elevation in liver enzymes
- History or evidence of eye disease (excluding changes in refraction and strabismus)
- Abnormal clinical lab results indicating evidence of anemia, immunosuppression, or immune deficiency disease
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- Have donated 1 unit (500 cc) or more of blood for any reason during the 2 months (56 days) preceding administration of the vaccine (as assessed by query)
- Plan to donate blood within 1 year following receipt of the vaccine
- History or evidence of previous infection with RVF or vaccination against RVF
- Any known allergies to components of the vaccine: Human serum albumin (stabilizer), Sol-U-Pro, Neomycin (antibiotic), sorbitol, L-proline, L-arginine, monosodium glutamate (MSG), or Urea
- Administration of another vaccine within 4 weeks of RVF MP-12 vaccination
- "Weekend" drinkers, males who drink more than 2 drinks a day and females who drink more than 1 drink a day, will be excluded
- Individuals who plan to start a new exercise program within two weeks of vaccination (either two weeks prior to or two weeks following vaccination) will be excluded. Individuals who are already on a regular exercise program and who have normal transaminase levels will not be excluded but will be advised not to increase their level of activity for a period of one month (for two weeks prior to until two weeks after vaccination). Individuals who do not exercise regularly and who participate in this study will be advised not to embark on an exercise program for the same time period.
- Volunteers will be cautioned against salivary contact and contact with infants, children under the age of 8 years, adults over the age of 64 years, and anyone who is immunocompromised or in poor health. Volunteers who feel unable to comply with these restrictions will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702
About this study
Official title: Safety and Immunogenicity of Live-Attenuated MP-12 Rift Valley Fever Vaccine in Humans, and Genetic Characterization of Virus Isolates Recovered From the Blood of Vaccinated Volunteers: A Phase II Study
This study is to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune response (which fights off infection) and if the vaccine is stable or if the virus used to make the vaccine changes into a different form once injected into the body. Twenty healthy volunteers (18-50 years old) will be vaccinated with a single dose of undiluted RVF MP-12, injected into a muscle.
Read the detailed description
Rift Valley Fever (RVF) is a mosquito-borne disease in Africa that affects both humans and animals. The disease poses a significant endemic disease threat, and the etiologic agent (RVF virus) possesses physical and biochemical characteristics that have resulted in its classification as a Category A Agent. Historically, this disease was confined to Africa. In September 2000, however, RVF appeared in the western part of the Kingdom of Saudi Arabia (843 cases with 114 deaths) and in Yemen (1,087 suspected cases with 121 deaths). It is thought that Rift Valley fever was introduced into this new geographic area through importation of infected livestock from Djibouti. Mosquito transmission has been subsequently demonstrated in these areas, suggesting that the disease may have become permanently established. A safe and effective RVF vaccine capable of inducing protective immunity after a single injection is urgently needed. Currently, no drug is available that will alter the course of the disease in humans or animals, nor is any licensed vaccine for RVF approved for human use. This protocol is an open-label, Phase II study to assess the safety, immunogenicity and genetic stability of RVF MP-12 vaccine in humans. The objectives of this study are to collect safety and immunogenicity data for an intramuscular (IM) injection of live, attenuated, mutagenized RVF 12th mutagenesis passage (MP-12) vaccine and characterize isolates of the Rift Valley fever (RVF) MP-12 vaccine recovered from blood of vaccinated volunteers using in vitro systems to evaluate genetic stability. A total of 20 volunteers will be recruited from among military and civilian persons at and around USAMRIID and from the general population in and around Frederick, Maryland, who expect to remain in the area for the duration of the study. Volunteers will be vaccinated with undiluted RVF MP-12 vaccine. Safety will be evaluated by recording the frequency and severity of clinical reactions to the vaccine, as well as by measuring complete blood counts and selected serum biochemistry (enzyme) values. Immunogenicity will be evaluated by measuring 80% plaque reduction neutralization (PRNT80) antibodies to RVF virus for periods up to 1 year following vaccination. Genetic stability of the vaccine will be evaluated by examining isolates recovered from blood of vaccinated volunteers by molecular sequencing techniques, and comparing these findings with those from the vaccine virus inoculum. Subjects will participate in the study for up to 1 year.
- Conditions
- Rift Valley Fever
- Being tested
- RVF MP-12
- Keywords
- Rift Valley Fever, vaccine
- Medical subject headings
- Rift Valley Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVF MP-12Biological
Administer 1 ml SQ
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | RVF MP-12 Receives: Biological: RVF MP-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Measured by the Number of Adverse Events
AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.
Measured: up to 1 year
Secondary outcomes (3)
Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus
Immune response will be assessed by measuring days to peak response for PRNT80 antibodies to RVF virus
Measured: Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12
Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine
Immune response will be assessed by measuring days to peak response for PRNT50 antibodies to RVF virus
Measured: Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
In vitro systems will be used to evaluate genetic stability (examining viremia levels in plasma by direct plaque assay techniques or by blind passage of plasma on Vero cells and sequencing the ribonucleic acid (RNA) and comparing these findings with those from the vaccine virus inoculum).
Measured: Days 0-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startAug 2006
- Primary completionMay 2008
- Study completionMay 2009
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.
- Other trials for Rift Valley FeverStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Phillip Pittman, MD, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415051
- Sponsor's protocol ID
- FY04-33, Log A-13698
- Acronym
- MP-12
- Status last verified
- Dec 2019
- First submitted
- 21 Dec 2006
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Safety and Immunogenicity of Live-Attenuated MP-12 Rift Valley Fever Vaccine in Humans, and Genetic Characterization of Virus Isolates Recovered From the Blood of Vaccinated Volunteers: A Phase II Study
- ClinicalTrials.gov ID
- NCT00415051
- Acronym / sponsor ID
- MP-12 / FY04-33, Log A-13698
- Conditions
- Rift Valley Fever
- Keywords
- Rift Valley Fever, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Aug 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Posted 1 Feb 2017
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 to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune response (which fights off infection) and if the vaccine is stable or if the virus used to make the vaccine changes into a different form once injected into the body. Twenty healthy volunteers (18-50 years old) will be vaccinated with a single dose of undiluted RVF MP-12, injected into a muscle.
Detailed description
Rift Valley Fever (RVF) is a mosquito-borne disease in Africa that affects both humans and animals. The disease poses a significant endemic disease threat, and the etiologic agent (RVF virus) possesses physical and biochemical characteristics that have resulted in its classification as a Category A Agent. Historically, this disease was confined to Africa. In September 2000, however, RVF appeared in the western part of the Kingdom of Saudi Arabia (843 cases with 114 deaths) and in Yemen (1,087 suspected cases with 121 deaths). It is thought that Rift Valley fever was introduced into this new geographic area through importation of infected livestock from Djibouti. Mosquito transmission has been subsequently demonstrated in these areas, suggesting that the disease may have become permanently established. A safe and effective RVF vaccine capable of inducing protective immunity after a single injection is urgently needed. Currently, no drug is available that will alter the course of the disease in humans or animals, nor is any licensed vaccine for RVF approved for human use. This protocol is an open-label, Phase II study to assess the safety, immunogenicity and genetic stability of RVF MP-12 vaccine in humans. The objectives of this study are to collect safety and immunogenicity data for an intramuscular (IM) injection of live, attenuated, mutagenized RVF 12th mutagenesis passage (MP-12) vaccine and characterize isolates of the Rift Valley fever (RVF) MP-12 vaccine recovered from blood of vaccinated volunteers using in vitro systems to evaluate genetic stability. A total of 20 volunteers will be recruited from among military and civilian persons at and around USAMRIID and from the general population in and around Frederick, Maryland, who expect to remain in the area for the duration of the study. Volunteers will be vaccinated with undiluted RVF MP-12 vaccine. Safety will be evaluated by recording the frequency and severity of clinical reactions to the vaccine, as well as by measuring complete blood counts and selected serum biochemistry (enzyme) values. Immunogenicity will be evaluated by measuring 80% plaque reduction neutralization (PRNT80) antibodies to RVF virus for periods up to 1 year following vaccination. Genetic stability of the vaccine will be evaluated by examining isolates recovered from blood of vaccinated volunteers by molecular sequencing techniques, and comparing these findings with those from the vaccine virus inoculum. Subjects will participate in the study for up to 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Biological: RVF MP-12RVF MP-12 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Between 18 and 50 years old
- Free of chronic medical conditions requiring ongoing therapy and in general good health as determined by a physician investigator
- Have a current (within 30 days of scheduled blood donation for this study) complete blood (cell) count (CBC) to include a Hct and Hgb that show no evidence of anemia, and total white blood cell with differential platelet counts that are within normal range, as well as hepatic enzyme (AST, ALT, LDH) values that are within normal laboratory ranges
- Negative human immunodeficiency virus (HIV) antibody test within 3 months preceding vaccination
- No evidence of pre-existing liver disease or current infection with Hepatitis A, B, or C virus as determined by serology
Key exclusion criteria (14 listed)
- History or evidence of liver disease/abnormality
- History of pre-existing thymic disease or thymic dysfunction (any cellular immune or antibody disorders)
- Be taking any medication, prescription or non-prescription (excluding dietary supplements), on a regular basis with the exception of contraceptive pills. This includes the regular use of statins, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, antivirals, topical steroidal creams, and nasal sprays. Conditions requiring intermittent medications and other decisions regarding eligibility due to medication use will be deferred to physician investigators.
- Elevation above the upper limit of laboratory normal values in liver enzymes, or history of unexplained elevation in liver enzymes
- History or evidence of eye disease (excluding changes in refraction and strabismus)
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 |
|---|---|---|
| RVF MP-12Administer 1 ml SQ | Biological | Single Group Assignment |
Primary outcome
Safety as Measured by the Number of Adverse Events
Time frame: up to 1 year
AE's will be assessed through study completion. Safety will be evaluated by recording the frequency of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.
3 secondary outcomes
Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus
Time frame: Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12
Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine
Time frame: Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Time frame: Days 0-14
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.
- Individual participant dataSharing planned: Undecided
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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 Pittman, MD principal investigator
USAMRIID Medical Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVF MP-12 in people with Rift Valley Fever, 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 16 inclusion and 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Feb 2017). 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?
Safety as Measured by the Number of Adverse Events (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.