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

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ClinicalTrials.gov Identifier: NCT00584194
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : July 14, 2017
Last Update Posted : July 14, 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: TSI-GSD 200 RVF Vaccine
Enrollment 278
Recruitment Details 278 subjects were enrolled at USAMRIID to participate
Pre-assignment Details  
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 278
Completed 143
Not Completed 135
Reason Not Completed
Not specified             135
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 153
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants
<=18 years
0
   0.0%
Between 18 and 65 years
153
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants
Female
50
  32.7%
Male
103
  67.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 153 participants
153
1.Primary Outcome
Title Safety: All Incidences of Erythema
Hide Description Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: number of events
Mild 15
Moderate 10
Severe 0
2.Secondary Outcome
Title Immunogenicity: Geometric Mean Titers After 3rd Vaccination
Hide Description Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)
Time Frame 28 days after dose 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is based on responders (defined as a subject achieving a PRNT80 >1:40)
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Male: GMT
47.3
(29.6 to 75.4)
Female: GMT
74.9
(43.6 to 128.6)
3.Secondary Outcome
Title Immunogenicity: Geometric Mean Titers Before 6-month Booster
Hide Description Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B
Time Frame Before 6-month booster
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is based on responders (defined as a subject achieving a PRNT80 >1:40)
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Male: GMT
8.5
(4.7 to 15.3)
Female: GMT
23.9
(8.2 to 68.9)
4.Secondary Outcome
Title Immunogenicity: Geometric Mean Titers at 12 Months
Hide Description Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Time Frame at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is based on responders (defined as a subject achieving a PRNT80 >1:40)
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Male: GMT
48.8
(20.1 to 118.1)
Female: GMT
48.4
(23.1 to 101.5)
5.Secondary Outcome
Title Immunogenicity: Geometric Mean Titers After 6-month Booster
Hide Description Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Time Frame month 6 after dose 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Population is based on responders (defined as a subject achieving a PRNT80 >1:40)
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 67
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Male: GMT
211.8
(140.5 to 319.3)
Female: GMT
189.0
(128.0 to 279.0)
Time Frame Annuals done for 5 years
Adverse Event Reporting Description Of the 278 subjects enrolled, 153 subjects received at least 1 vaccination of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) and 125 subjects were enrolled in the study but did not receive RVF vaccine. Each dose (primary, booster, or supplemental) consisted of 1.0 mL of vaccine delivered subcutaneously in the upper outer aspect of the arm (triceps area).
 
Arm/Group Title TSI-GSD 200 RVF Vaccine
Hide Arm/Group Description 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.
All-Cause Mortality
TSI-GSD 200 RVF Vaccine
Affected / at Risk (%)
Total   0/153 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
TSI-GSD 200 RVF Vaccine
Affected / at Risk (%) # Events
Total   11/153 (7.19%)    
Cardiac disorders   
Atrial fibrillation * 1  1/153 (0.65%)  1
Injury, poisoning and procedural complications   
Loss of consciousness during physcial assault * 1  1/153 (0.65%)  1
Skin and subcutaneous tissue disorders   
Cyst exicision * 1  1/153 (0.65%)  1
Surgical and medical procedures   
Rotator cuff surgery * 1  1/153 (0.65%)  1
Thyroidectomy * 1  1/153 (0.65%)  1
Obstructive sleep apnea surgery * 1  1/153 (0.65%)  1
Back surgery * 1  1/153 (0.65%)  1
Meniscus repair surgery * 1  1/153 (0.65%)  1
Partial sigmoidectomy * 1  1/153 (0.65%)  1
Laproscopic surgery for RLQ pain * 1  1/153 (0.65%)  1
Left nephrectomy * 1  1/153 (0.65%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TSI-GSD 200 RVF Vaccine
Affected / at Risk (%) # Events
Total   75/153 (49.02%)    
Blood and lymphatic system disorders   
Swollen neck glands  1 [1]  1/153 (0.65%)  1
Lymphadenopathy  1 [2]  1/153 (0.65%)  1
Tender lymph nodes  1 [2]  1/153 (0.65%)  1
Cardiac disorders   
Chest pain  1 [1]  1/153 (0.65%)  1
Chest pain  1 [2]  1/153 (0.65%)  1
Tight chest  1 [2]  1/153 (0.65%)  1
Bradycardia  1 [1]  1/153 (0.65%)  1
Ear and labyrinth disorders   
Ear pressure  1 [1]  1/153 (0.65%)  1
Gastrointestinal disorders   
Sore throat  1 [1]  3/153 (1.96%)  3
Sore throat  1 [3]  2/153 (1.31%)  2
Sore throat  1 [2]  4/153 (2.61%)  4
Nausea  1 [1]  1/153 (0.65%)  1
Nausea  1 [3]  2/153 (1.31%)  2
Nausea  1 [2]  2/153 (1.31%)  2
Diarrhea  1 [2]  2/153 (1.31%)  2
Scratchy throat  1 [3]  2/153 (1.31%)  2
Abdominal cramping  1 [2]  1/153 (0.65%)  1
Stomach ache  1 [2]  1/153 (0.65%)  1
GI problems  1 [2]  1/153 (0.65%)  1
Stomach virus  1 [1]  1/153 (0.65%)  1
Abdomen pain  1 [1]  1/153 (0.65%)  1
Bil umbilial hernias  1 [1]  1/153 (0.65%)  1
Inguinal hernia  1 [1]  1/153 (0.65%)  1
General disorders   
Fatigue  1 [1]  2/153 (1.31%)  2
Fatigue  1 [3]  8/153 (5.23%)  8
Fatigue  1 [2]  1/153 (0.65%)  1
Malaise  1 [1]  2/153 (1.31%)  2
Malaise  1 [3]  6/153 (3.92%)  6
Malaise  1 [2]  1/153 (0.65%)  1
Fever  1 [1]  1/153 (0.65%)  1
Fever  1 [3]  2/153 (1.31%)  2
warm  1 [2]  1/153 (0.65%)  1
Pain  1 [1]  2/153 (1.31%)  2
Axillary tenderness  1 [4]  1/153 (0.65%)  1
Swelling  1 [2]  1/153 (0.65%)  1
Neck swollen  1 [1]  1/153 (0.65%)  1
Absence from work  1 [5]  1/153 (0.65%)  1
Pressure  1 [3]  1/153 (0.65%)  1
Sweating  1 [3]  1/153 (0.65%)  1
Induration  1 [4]  10/153 (6.54%)  10
Induration  1 [1]  1/153 (0.65%)  1
Warm  1 [4]  1/153 (0.65%)  1
Axillary pain  1 [6]  1/153 (0.65%)  1
Swelling  1 [4]  1/153 (0.65%)  1
Burning and pinching  1 [1]  1/153 (0.65%)  1
Immune system disorders   
Hives  1 [2]  1/153 (0.65%)  1
Upper eyelid swollen  1 [1]  1/153 (0.65%)  1
Face swelling  1 [2]  1/153 (0.65%)  1
Infections and infestations   
Chest congestion  1 [1]  1/153 (0.65%)  1
Bronchitis  1 [1]  1/153 (0.65%)  1
Nail fungus  1 [1]  1/153 (0.65%)  1
Pinkeye  1 [1]  1/153 (0.65%)  1
Abcess  1 [1]  1/153 (0.65%)  1
Injury, poisoning and procedural complications   
Bruising  1 [1]  1/153 (0.65%)  1
Fracture  1 [1]  2/153 (1.31%)  2
Lacerations  1 [1]  2/153 (1.31%)  2
Admittance  1 [1]  1/153 (0.65%)  1
Concussion  1 [1]  1/153 (0.65%)  1
Bump on right arm  1 [1]  1/153 (0.65%)  1
Knee injury  1 [1]  1/153 (0.65%)  1
Itchy bumps on arms  1 [6]  1/153 (0.65%)  1
Eye trauma  1 [1]  1/153 (0.65%)  1
Tender at site  1 [4]  8/153 (5.23%)  8
Bruising  1 [4]  6/153 (3.92%)  6
Warmth at site  1 [4]  4/153 (2.61%)  4
Tenderness  1 [4]  3/153 (1.96%)  3
Soreness  1 [4]  2/153 (1.31%)  2
Hot at site  1 [4]  1/153 (0.65%)  1
Tender to touch  1 [4]  1/153 (0.65%)  1
Pain at site  1 [4]  1/153 (0.65%)  1
Swelling at site  1 [4]  1/153 (0.65%)  1
Investigations   
Elevated B/P  1 [4]  1/153 (0.65%)  1
URI  1 [3]  1/153 (0.65%)  1
Metabolism and nutrition disorders   
Loss of appetite  1 [2]  1/153 (0.65%)  1
Edema  1 [4]  2/153 (1.31%)  2
Musculoskeletal and connective tissue disorders   
Myalgia  1 [3]  8/153 (5.23%)  8
Myalgia  1 [2]  1/153 (0.65%)  1
Chills  1 [1]  1/153 (0.65%)  1
Chills  1 [3]  2/153 (1.31%)  2
Chills  1 [2]  1/153 (0.65%)  1
Back pain  1 [1]  1/153 (0.65%)  1
Back pain  1 [3]  1/153 (0.65%)  1
Low back pain  1 [1]  2/153 (1.31%)  2
Arthralgia  1 [3]  1/153 (0.65%)  1
Stiff neck  1 [3]  1/153 (0.65%)  1
Knee pain  1 [1]  1/153 (0.65%)  1
Muscle strain  1 [1]  1/153 (0.65%)  1
Neck pain  1 [1]  1/153 (0.65%)  1
Muscle fatigue  1 [3]  1/153 (0.65%)  1
Joint pain  1 [3]  1/153 (0.65%)  1
Nervous system disorders   
Headache  1 [1]  1/153 (0.65%)  1
Headache  1 [3]  13/153 (8.50%)  13
Headache  1 [2]  1/153 (0.65%)  1
Headache  1 [6]  2/153 (1.31%)  2
Light headedness  1 [1]  1/153 (0.65%)  1
Light headedness  1 [3]  1/153 (0.65%)  1
Blurred vision  1 [1]  1/153 (0.65%)  1
Foggy head  1 [1]  1/153 (0.65%)  1
Feeling faint  1 [4]  1/153 (0.65%)  1
Flashes of light  1 [2]  1/153 (0.65%)  1
Sinus headache  1 [3]  1/153 (0.65%)  1
Migraine  1 [3]  1/153 (0.65%)  1
Burning sensation  1 [4]  1/153 (0.65%)  1
Tingling  1 [4]  1/153 (0.65%)  1
Psychiatric disorders   
Hoarseness  1 [2]  1/153 (0.65%)  1
Renal and urinary disorders   
Urination discomfort  1 [1]  1/153 (0.65%)  1
Respiratory, thoracic and mediastinal disorders   
Sinusitis  1 [1]  5/153 (3.27%)  5
Sinusitis  1 [3]  1/153 (0.65%)  1
Sinusitis  1 [2]  1/153 (0.65%)  1
Congestion  1 [1]  1/153 (0.65%)  1
Congestion  1 [3]  4/153 (2.61%)  4
Congestion  1 [2]  1/153 (0.65%)  1
Cough  1 [1]  2/153 (1.31%)  2
Cough  1 [3]  2/153 (1.31%)  2
Cough  1 [2]  1/153 (0.65%)  1
Nasal congestion  1 [1]  3/153 (1.96%)  3
Nasal congestion  1 [3]  1/153 (0.65%)  1
Sinus congestion  1 [3]  2/153 (1.31%)  2
Sinus congestion  1 [2]  1/153 (0.65%)  1
Stuffy nose  1 [1]  1/153 (0.65%)  1
Stuffy nose  1 [2]  1/153 (0.65%)  1
Dry cough  1 [1]  1/153 (0.65%)  1
Dry cough  1 [2]  1/153 (0.65%)  1
Runny nose  1 [1]  1/153 (0.65%)  1
Runny nose  1 [3]  1/153 (0.65%)  1
Head cold  1 [2]  1/153 (0.65%)  1
Sneezing  1 [2]  1/153 (0.65%)  1
Wheezing  1 [2]  1/153 (0.65%)  1
Skin and subcutaneous tissue disorders   
Pruritus  1 [4]  1/153 (0.65%)  1
Pruritus  1 [1]  2/153 (1.31%)  2
Pruritus  1 [2]  1/153 (0.65%)  1
Rash  1 [1]  2/153 (1.31%)  2
Upper eyelid pain to touch  1 [1]  1/153 (0.65%)  1
Upper eyelid itchy  1 [1]  1/153 (0.65%)  1
Pruritus  1 [4]  11/153 (7.19%)  11
Pruritus  1 [1]  1/153 (0.65%)  1
Erythema  1 [4]  14/153 (9.15%)  14
Erythema  1 [1]  2/153 (1.31%)  2
Ecchymosis  1 [4]  2/153 (1.31%)  2
Redness  1 [4]  1/153 (0.65%)  1
Surgical and medical procedures   
Rotator cuff screw removal  1 [1]  1/153 (0.65%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
[1]
Unrelated
[2]
Unlikely related
[3]
Possibly related
[4]
Definitely related
[5]
No data
[6]
Probably related
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
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