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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00415051
First received: December 21, 2006
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: December 6, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: Rift Valley Fever
Intervention: Biological: RVF MP-12

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty subjects were planned; 31 were screened, 11 did not meet the inclusion/exclusion criteria, 20 satisfied inclusion/exclusion criteria, 20 were enrolled, 1 was excluded (received another vaccine within 30 days of intended MP-12 vaccination), and 19 received vaccine and completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Group Assignment

RVF MP-12

RVF MP-12: Administer 1 ml SQ


Participant Flow:   Overall Study
    Single Group Assignment
STARTED   20 
COMPLETED   19 
NOT COMPLETED   1 
Protocol Violation                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Group Assignment

RVF MP-12

RVF MP-12: Administer 1 ml SQ


Baseline Measures
   Single Group Assignment 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      19 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 33 
 (23 to 50) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  47.4% 
Male      10  52.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  10.5% 
White      17  89.5% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures
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1.  Primary:   Safety as Measured by the Number of Adverse Events   [ Time Frame: up to 1 year ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   Genetic Stability - Characterize Viral Isolate (Plasma) Frequency   [ Time Frame: Days 0-14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: COL Phillip R. Pittman, MD, MPH
Organization: US Army Medical Research Institute of infectious Diseases (USAMRIID)
phone: 301-619-4994
e-mail: phillip.pitman@amedd.army.mil



Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00415051     History of Changes
Other Study ID Numbers: FY04-33, Log A-13698
Study First Received: December 21, 2006
Results First Received: December 6, 2016
Last Updated: April 14, 2017