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

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ClinicalTrials.gov Identifier: NCT00415051
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : February 1, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Rift Valley Fever
Intervention Biological: RVF MP-12
Enrollment 20
Recruitment Details 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  
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

Overall Number of Baseline Participants 19
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
33
(23 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Safety as Measured by the Number of Adverse Events
Hide Description 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.
Time Frame up to 1 year
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[Not Specified]
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: AEs
Local AEs Related and Not Related to Study Drug 22
Systemic AEs Related and Not Related to Study Drug 130
2.Secondary Outcome
Title Immune Response Assessed by Measuring Days to Peak Response for PRNT80 Antibodies to RVF Virus
Hide Description Immune response will be 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
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[Not Specified]
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Days
Days to peak PRNT80 71.1  (74.4)
Days to peak PRNT80 response 16.6  (6.7)
3.Secondary Outcome
Title Immune Response Assessed by Measuring Days to Peak Response for (PRNT50) RVP MP-12 Vaccine
Hide Description Immune response will be assessed by measuring days to peak response for PRNT50 antibodies to RVF virus
Time Frame Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12
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[Not Specified]
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Days
Days to peak PRNT50 82.2  (101.1)
Days to peak PRNT50 response 15.0  (6.8)
4.Secondary Outcome
Title Genetic Stability - Characterize Viral Isolate (Plasma) Frequency
Hide Description 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).
Time Frame Days 0-14
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1 subject was excluded for receiving another vaccination within 30 days of intended MP-12 vaccination.
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0 after vaccination - Negative
18
  94.7%
Day 0 after vaccination - Positive
0
   0.0%
Day 1 after vaccination - Negative
19
 100.0%
Day 1 after vaccination - Positive
0
   0.0%
Day 2 after vaccination - Negative
19
 100.0%
Day 2 after vaccination - Positive
0
   0.0%
Day 3 after vaccination - Negative
19
 100.0%
Day 3 after vaccination - Positive
0
   0.0%
Day 4 after vaccination - Negative
18
  94.7%
Day 4 after vaccination - Positive
1
   5.3%
Day 5 after vaccination - Negative
17
  89.5%
Day 5 after vaccination - Positive
2
  10.5%
Day 6 after vaccination - Negative
17
  89.5%
Day 6 after vaccination - Positive
2
  10.5%
Day 7 after vaccination - Negative
18
  94.7%
Day 7 after vaccination - Positive
1
   5.3%
Day 8 after vaccination - Negative
18
  94.7%
Day 8 after vaccination - Positive
1
   5.3%
Day 9 after vaccination - Negative
17
  89.5%
Day 9 afterr vaccination - Positive
2
  10.5%
Day 10 after vaccination - Negative
19
 100.0%
Day 10 after vaccination - Positive
0
   0.0%
Day 11 after vaccination - Negative
19
 100.0%
Day 11 after vaccination - Positive
0
   0.0%
Day 12 afterr vaccination - Negative
19
 100.0%
Day 12 after vaccination - Positive
0
   0.0%
Day 13 after vaccination - Negative
19
 100.0%
Day 13 after vaccination - Positive
0
   0.0%
Day 14 after vaccination - Negative
19
 100.0%
Day 14 after vaccination - Positive
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
 
Arm/Group Title Single Group Assignment
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RVF MP-12

RVF MP-12: Administer 1 ml SQ

All-Cause Mortality
Single Group Assignment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Group Assignment
Affected / at Risk (%) # Events
Total   0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Group Assignment
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Cervial nodes slightly tender  [1]  1/19 (5.26%)  1
Increase in bleeding post venipuncture  [1]  1/19 (5.26%)  1
Cardiac disorders   
Heart palpitations  [2]  1/19 (5.26%)  1
Ear and labyrinth disorders   
Ear discomfort  [1]  1/19 (5.26%)  1
Eye disorders   
Left eye itching  [1]  1/19 (5.26%)  1
Gastrointestinal disorders   
Sore throat  [1]  3/19 (15.79%)  3
Throat scratchy and sore  [1]  1/19 (5.26%)  1
Nausea  [1]  5/19 (26.32%)  5
Diarrhea  [1]  4/19 (21.05%)  4
Vomiting  [1]  2/19 (10.53%)  2
Abdominal cramping  [1]  1/19 (5.26%)  1
Dehydration  [1]  1/19 (5.26%)  1
Sore throat  [2]  2/19 (10.53%)  2
Emesis  [2]  1/19 (5.26%)  1
Indigestion  [2]  1/19 (5.26%)  1
Nausea  [2]  1/19 (5.26%)  1
General disorders   
Fatigue  [1]  10/19 (52.63%)  10
Fever  [1]  4/19 (21.05%)  4
Immune system disorders   
Allergic reaction  [2]  1/19 (5.26%)  1
Infections and infestations   
Conjunctivitis (OS)  [1]  1/19 (5.26%)  1
Injury, poisoning and procedural complications   
Shoulder injury  [2]  1/19 (5.26%)  1
Traumatic injury to L middle finger  [2]  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Chills  [1]  2/19 (10.53%)  2
Muscle pain  [1]  6/19 (31.58%)  6
Pain  [1]  1/19 (5.26%)  1
Back pain  [1]  1/19 (5.26%)  1
Lower back discomfort  [1]  1/19 (5.26%)  1
Knee joint pain  [1]  1/19 (5.26%)  1
Dental pain  [1]  1/19 (5.26%)  1
Ankel pain  [1]  1/19 (5.26%)  1
Stiff neck  [1]  1/19 (5.26%)  1
Knee pain  [2]  1/19 (5.26%)  1
Muscle ache  [2]  3/19 (15.79%)  3
Pain  [2]  1/19 (5.26%)  1
Pain (chest and back)  [2]  1/19 (5.26%)  1
Pain (lower back)  [2]  1/19 (5.26%)  1
Pain (shoulder)  [2]  1/19 (5.26%)  1
Shin splints  [2]  1/19 (5.26%)  1
Stiff neck  [2]  1/19 (5.26%)  1
Nervous system disorders   
Headache  [1]  16/19 (84.21%)  16
Blurred vision  [1]  2/19 (10.53%)  2
Eyelid twitching  [1]  1/19 (5.26%)  1
Dizziness  [1]  1/19 (5.26%)  1
Lightheaded  [1]  1/19 (5.26%)  1
Spacey  [1]  1/19 (5.26%)  1
Eye twitching  [2]  1/19 (5.26%)  1
Dizziness  [2]  1/19 (5.26%)  1
Migrane  [2]  2/19 (10.53%)  2
Psychiatric disorders   
Insomnia  [2]  1/19 (5.26%)  1
Reproductive system and breast disorders   
Menstrual cramps  [1]  1/19 (5.26%)  1
Pain (testicle)  [2]  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Flu-like symptoms  [1]  6/19 (31.58%)  6
Nasal congestion  [1]  6/19 (31.58%)  6
Rhinorrhea  [1]  5/19 (26.32%)  5
Cough  [1]  3/19 (15.79%)  3
Chest congestion  [1]  1/19 (5.26%)  1
Cold  [2]  2/19 (10.53%)  2
Laryngitis  [2]  1/19 (5.26%)  1
Nasal congestion  [2]  1/19 (5.26%)  1
Cough  [2]  3/19 (15.79%)  3
Pneumonia  [2]  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Tenderness (vaccine site)  [1]  9/19 (47.37%)  9
Induration  [1]  3/19 (15.79%)  3
Redness (vaccine site)  [1]  3/19 (15.79%)  3
Clammy skin (hands)  [1]  2/19 (10.53%)  2
Bruise  [1]  2/19 (10.53%)  2
Itching  [1]  2/19 (10.53%)  2
Injection site warm  [1]  1/19 (5.26%)  1
Redness (phlebotomy site)  [1]  1/19 (5.26%)  1
Cold sore  [1]  1/19 (5.26%)  1
Surgical and medical procedures   
Scar reconstruction ABD wall liposuction  [2]  1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
< 30 Days Post Vaccination
[2]
31 days - 1 year post vaccine
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
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
First Submitted: December 21, 2006
First Posted: December 22, 2006
Results First Submitted: December 6, 2016
Results First Posted: February 1, 2017
Last Update Posted: May 19, 2017