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Trial record 4 of 40 for:    "Yellow fever"

Trial of Yellow Fever Inactivated Vaccine

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ClinicalTrials.gov Identifier: NCT00995865
Recruitment Status : Completed
First Posted : October 15, 2009
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Yellow Fever
Interventions Biological: XRX-001 Inactivated yellow fever vaccine
Biological: Placebo
Enrollment 60
Recruitment Details 2 of the Subjects in the High-Dose made it thru the study, however, it was later found that those 2 subjects vaccinated prior to joining this study. One (1) subject in the "Placebo" went thru the the study, but was later lost to follow-up.
Pre-assignment Details 60 Subjects enrolled in this study. 3 Subjects discontinued in this study.
Arm/Group Title High Dose Mid Dose Placebo
Hide Arm/Group Description XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL

NaCl Injectable 0.9%

Placebo: NaCl Injectable 0.9%

Period Title: Overall Study
Started 24 24 12
Completed 22 24 11
Not Completed 2 0 1
Reason Not Completed
Protocol Violation             2             0             0
Lost to Follow-up             0             0             1
Arm/Group Title High Dose Group Mid-Dose Group Placebo Group Total
Hide Arm/Group Description Two groups of 24 subjects each, (one arm called a high dose group, the other a Mid-Dose group) were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for the (mid dose). Two groups of 24 subjects each were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for this (mid dose) group. This third group of 12 subjects were to receive a placebo (0.9% normal saline for injection). Total of all reporting groups
Overall Number of Baseline Participants 22 24 11 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 11 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
24
 100.0%
11
 100.0%
57
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 24 participants 11 participants 57 participants
34  (10.0) 31  (9.1) 29  (8.2) 32  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 24 participants 11 participants 57 participants
Female
9
  40.9%
10
  41.7%
6
  54.5%
25
  43.9%
Male
13
  59.1%
14
  58.3%
5
  45.5%
32
  56.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 24 participants 11 participants 57 participants
22 24 11 57
1.Primary Outcome
Title The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.
Hide Description

Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.

After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.

Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.

At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.

Time Frame Measured from 0 up to 21 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were to return to the clinic on Days 3,10, 21, 24, 31,and 42 with the second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.
Arm/Group Title High Dose Group Mid Dose Group Placebo Group
Hide Arm/Group Description:

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.

24 Subjects were examined in this group.

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL

Subjects were administered with NaCl Injectable 0.9%.

12 Subjects were examined in this group.

Overall Number of Participants Analyzed 24 24 12
Measure Type: Number
Unit of Measure: participants
Days 0-21 (1st injection)-Pain 13 13 2
Days 0-21 (1st injection)-Redness 22 21 10
Days 0-21 (1st injection)-Tenderness 15 19 4
Days 0-21 (1st injection)-Swelling 22 21 10
Days 0-21 (1st injection)-Itching 3 1 0
Days 0-21 (1st injection)-Diarrhea 0 4 3
Days 0-21 (1st injection)-Malaise 4 2 3
Days 0-21 (1st injection)-Headache 2 8 7
Days 0-21 (1st injection)-Tiredness 7 2 5
Days 0-21 (1st injection)-Nausea 3 0 1
2.Primary Outcome
Title The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.
Hide Description

Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.

After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.

Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.

At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.

Time Frame Measured from 22 up to 42 Days.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were to combined at days 22 to 42 . At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.
Arm/Group Title High Dose Group Mid Dose Group Placebo Group
Hide Arm/Group Description:

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.

24 Subjects were examined in this group.

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL

Subjects were administered with NaCl Injectable 0.9%.

12 Subjects were examined in this group.

Overall Number of Participants Analyzed 24 24 12
Measure Type: Number
Unit of Measure: participants
Days 22-42 (2nd injection)-Pain 6 8 0
Days 22-42 (2nd injection)-Tenderness 8 10 0
Days 22-42 (2nd injection)-Redness 12 16 7
Days 22-42 (2nd injection)-Swelling 12 16 7
Days 22-42 (2nd injection)-Vomiting 1 2 3
Days 22-42 (2nd injection)-Malaise 1 4 5
Days 22-42 (2nd injection)-Headache 1 6 5
Days 22-42 (2nd injection)-Muscle Ache 0 3 3
Days 22-42 (2nd injection)-Feverishness 0 3 3
Days 22-42 (2nd injection)-Chills 0 2 1
Days 22-42 (2nd injection)-Tiredness 2 4 4
Days 22-42 (2nd injection)-Nausea 1 3 3
Days 22-42 (2nd injection)-Drowsiness 1 5 3
Days 22-42 (2nd injection)-Shortness of Breath 0 2 0
3.Secondary Outcome
Title Percentage of Subjects With Seroconversions or Who Are Seropositive Using 2 Dose Levels of XRX-001
Hide Description Secondary immunogenicity endpoints will use 2 dose levels of XRX-001 inactivated yellow fever vaccine determined by 50% plaque reduction neutralization test (PRNT50). Dose groups were to be compared for neutralizing antibody seroconverison rate, distribution of antibody titers, and geometric mean antibody titers (GMTs) to yellow fever 17D virus. The seroconversion rates and GMT neutralizing antibody titers for each dose group and all dose groups combined; The reverse cumulative distribution curve of antibody titers;
Time Frame Days 21 and 42, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositive was to show a significant level of serum antibodies, or other immunologic marker in the serum, indicating previous exposure to the infectious agent being tested. In immunology, seroconversion is the time period during which a specific antibody develops and becomes detectable in the blood.
Arm/Group Title High Dose Group Mid Dose Group Placebo Group
Hide Arm/Group Description:
XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL

NaCl Injectable 0.9%

Placebo: NaCl Injectable 0.9%

Overall Number of Participants Analyzed 22 24 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Seropositive-Day 21(21 Days after 1st Injection)
46
(24 to 68)
13
(3 to 32)
0
(0 to 29)
Serocovert-Day 21 (21 Days after 1st Injection)
32
(14 to 55)
13
(3 to 32)
0
(0 to 29)
Seropositivity-Day 31 (10 Days after second Inj)
100
(85 to 100)
88
(68 to 97)
0
(0 to 29)
Seroconvert- Day 31 (10 Days after second Inj)
100
(85 to 100)
75
(53 to 90)
0
(0 to 29)
Seropositivity -Day 42 (21 Days after 2nd Inj)
100
(85 to 100)
88
(68 to 97)
0
(0 to 29)
Seroconvert-Day 42 (21 Days after 2nd Inj)
100
(85 to 100)
71
(49 to 87)
0
(0 to 29)
4.Secondary Outcome
Title Distribution of Geometric Mean Antibody Titers (GMTs) to Yellow Fever 17D Virus.
Hide Description Geometric mean antibody titers (GMT) neutralizing antibody titers for each dose groups.
Time Frame GMT titers measured at days 21, 31 and 42 for different dose rates.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Group Mid Dose Group Placebo Group
Hide Arm/Group Description:
XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL

NaCl Injectable 0.9%

Placebo: NaCl Injectable 0.9%

Overall Number of Participants Analyzed 22 24 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric Antibody titers
Geometric mean titer Day 21--21 Days 1st Inj)
10
(7 to 15)
6
(5 to 8)
5
(5 to 5)
Geometric mean titer Day 31--10 Days after 2nd Inj
146
(104 to 203)
39
(22 to 69)
5
(5 to 5)
Geometric mean titer Day 42--21 Days after 2nd Inj
113
(81 to 159)
30
(18 to 49)
5
(5 to 5)
Time Frame Two intramuscular injections at an interval of 21 days
Adverse Event Reporting Description Two intramuscular injections at an interval of 21 days. First injection administered on day with an interval of 21 days followed by a second injection on day 22.
 
Arm/Group Title High Dose First Injection Mid Dose First Injection Placebo First Injection High Dose Second Injection Mid Dose Second Injection Placebo Second Injection
Hide Arm/Group Description

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.

First injection.

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.

First injection.

NaCl Injectable 0.9%

Placebo: NaCl Injectable 0.9% First injection.

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.

Second injection at an interval of 21 days

XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.

Second injection.

NaCl Injectable 0.9%

Placebo: NaCl Injectable 0.9% Second injection.

All-Cause Mortality
High Dose First Injection Mid Dose First Injection Placebo First Injection High Dose Second Injection Mid Dose Second Injection Placebo Second Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose First Injection Mid Dose First Injection Placebo First Injection High Dose Second Injection Mid Dose Second Injection Placebo Second Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/12 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose First Injection Mid Dose First Injection Placebo First Injection High Dose Second Injection Mid Dose Second Injection Placebo Second Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/24 (100.00%)      24/24 (100.00%)      12/12 (100.00%)      24/24 (100.00%)      24/24 (100.00%)      12/12 (100.00%)    
Gastrointestinal disorders             
Diarrhea  1 [1]  0/24 (0.00%)  0 4/24 (16.67%)  4 3/12 (25.00%)  3 0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0
Nausea  1 [2]  3/24 (12.50%)  3 0/24 (0.00%)  0 1/12 (8.33%)  1 1/24 (4.17%)  1 3/24 (12.50%)  3 3/12 (25.00%)  3
Vomiting  1 [3]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 2/24 (8.33%)  2 3/12 (25.00%)  3
General disorders             
Malaise  1 [4]  4/24 (16.67%)  4 2/24 (8.33%)  2 3/12 (25.00%)  3 1/24 (4.17%)  1 4/24 (16.67%)  4 5/12 (41.67%)  5
Headache  1 [5]  2/24 (8.33%)  2 8/24 (33.33%)  8 7/12 (58.33%)  7 1/24 (4.17%)  1 6/24 (25.00%)  6 5/12 (41.67%)  5
Tiredness  1 [6]  7/24 (29.17%)  7 2/24 (8.33%)  2 5/12 (41.67%)  5 2/24 (8.33%)  2 4/24 (16.67%)  4 4/12 (33.33%)  4
Feverishness  1 [7]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 3/24 (12.50%)  3 3/12 (25.00%)  3
Chills  1 [8]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 1/12 (8.33%)  1
Drowsiness  1 [9]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 1/24 (4.17%)  1 5/24 (20.83%)  5 3/12 (25.00%)  3
Musculoskeletal and connective tissue disorders             
Muscle Ache  1 [10]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 3/24 (12.50%)  3 3/12 (25.00%)  3
Respiratory, thoracic and mediastinal disorders             
Shortness of Breath  1 [11]  0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders             
Pain at Injection site  1 [12]  13/24 (54.17%)  13 13/24 (54.17%)  13 2/12 (16.67%)  2 6/24 (25.00%)  6 8/24 (33.33%)  8 0/12 (0.00%)  0
Tenderness at injection site  1 [13]  15/24 (62.50%)  15 19/24 (79.17%)  19 4/12 (33.33%)  4 8/24 (33.33%)  8 10/24 (41.67%)  10 0/12 (0.00%)  0
Redness at Site of Inection  1 [14]  22/24 (91.67%)  22 21/24 (87.50%)  21 10/12 (83.33%)  10 12/24 (50.00%)  12 16/24 (66.67%)  16 7/12 (58.33%)  7
Swelling at site of injection  1 [15]  22/24 (91.67%)  22 21/24 (87.50%)  21 10/12 (83.33%)  10 12/24 (50.00%)  12 16/24 (66.67%)  16 7/12 (58.33%)  7
Itching at site of ijnection  1 [16]  3/24 (12.50%)  3 1/24 (4.17%)  1 0/12 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
[1]
Diarrhea
[2]
Nausea
[3]
Vomiting
[4]
Malaise
[5]
Headache
[6]
Tiredness
[7]
Feverishness
[8]
Chills
[9]
Drowsiness
[10]
Muscle Ache
[11]
Shortness of Breath
[12]
General pain at the site of injection
[13]
Tenderness at the site of injection
[14]
Redness at the site of injection
[15]
Swelling at the site of injection
[16]
Itching a the site of injection
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: Amanda Culliton
Organization: GE Healthcare- Life Sciences
Phone: 1-508-683-2232
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00995865     History of Changes
Other Study ID Numbers: X-100-001
First Submitted: October 8, 2009
First Posted: October 15, 2009
Results First Submitted: October 12, 2015
Results First Posted: May 5, 2016
Last Update Posted: May 5, 2016