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Safety and Immunogenicity Study of Rift Valley Fever Vaccine (RVF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584194
First Posted: January 2, 2008
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
Results First Submitted: February 22, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Rift Valley Fever
Intervention: Biological: TSI-GSD 200 RVF Vaccine

  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
278 subjects were enrolled at USAMRIID to participate

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
TSI-GSD 200 RVF Vaccine Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.

Participant Flow:   Overall Study
    TSI-GSD 200 RVF Vaccine
STARTED   278 
COMPLETED   143 
NOT COMPLETED   135 
Not specified                135 



  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.
Baseline includes all subjects vaccinated and doesn't account for drop outs, deviations, and withdraws. Demographics weren't given in Final Clinical Study Report. Numbers are reliant on numbers of females and males receiving vaccination.

Reporting Groups
  Description
TSI-GSD 200 RVF Vaccine

Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.

TSI-GSD 200 RVF Vaccine: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.


Baseline Measures
   TSI-GSD 200 RVF Vaccine 
Overall Participants Analyzed 
[Units: Participants]
 153 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      153 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      50  32.7% 
Male      103  67.3% 
Region of Enrollment 
[Units: Participants]
 
United States   153 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety: All Incidences of Erythema   [ Time Frame: 12 months ]

2.  Secondary:   Immunogenicity: Geometric Mean Titers After 3rd Vaccination   [ Time Frame: 28 days after dose 3 ]

3.  Secondary:   Immunogenicity: Geometric Mean Titers Before 6-month Booster   [ Time Frame: Before 6-month booster ]

4.  Secondary:   Immunogenicity: Geometric Mean Titers at 12 Months   [ Time Frame: at 12 months ]

5.  Secondary:   Immunogenicity: Geometric Mean Titers After 6-month Booster   [ Time Frame: month 6 after dose 4 ]


  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
No text entered.


  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: Janice Rusnak, MD
Organization: USAMRIID Medical Division
phone: 301-619-4156
e-mail: janice.rusnak@amedd.army.mil



Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00584194     History of Changes
Other Study ID Numbers: A-12592
FY03-05 ( Other Identifier: SIP )
First Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: February 22, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017