Trials Sponsors Conditions Drugs Pricing

Conditions

Rift Valley Fever

Keywords

Rift Valley Fever, vaccine

Outcome Measures

Primary Outcomes (1)

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.
up to 1 year

Secondary Outcomes (3)

Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus
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
Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12
Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Days 0-14

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

RVF MP-12

Biological: RVF MP-12

Interventions

RVF MP-12Biological

Administer 1 ml SQ

Single Group Assignment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

Sponsors & Collaborators

U.S. Army Medical Research and Development Command
US federal agencylead

Study Sites (1)

US Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

MeSH Terms

Conditions

Rift Valley Fever

Condition Hierarchy (Ancestors)

Hepatitis, Viral, AnimalHepatitis, AnimalInfectionsMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsVirus DiseasesBunyaviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralHepatitisLiver DiseasesDigestive System DiseasesAnimal Diseases

Results Point of Contact

Title: COL Phillip R. Pittman, MD, MPH
Organization: US Army Medical Research Institute of infectious Diseases (USAMRIID)

Study Officials

Phillip Pittman, MD
USAMRIID Medical Division
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: FED
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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
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.

Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Single Group Assignment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Single Group Assignment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations