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Trial record 68 of 75 for:    "Rabies" | "Immunologic Factors"

Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali

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ClinicalTrials.gov Identifier: NCT00308061
Recruitment Status : Completed
First Posted : March 28, 2006
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
United States Agency for International Development (USAID)
Information provided by:
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: FMP1/AS02A
Biological: Imovax Rabies Vaccine
Enrollment 40
Recruitment Details 40 subjects were randomized at 1:1 ratio to receive either FMP1/AS02A or Imovax Rabies vaccine. All 40 subjects received all 3 immunizations and were followed for 12 months
Pre-assignment Details  
Arm/Group Title FMP1/AS02A Vaccine Imovax Rabies Vaccine
Hide Arm/Group Description

500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.

1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title FMP1/AS02A Vaccine Imovax Rabies Vaccine Total
Hide Arm/Group Description

500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.

1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
40.3  (8.0) 38.5  (10.0) 39.4  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
5
  25.0%
2
  10.0%
7
  17.5%
Male
15
  75.0%
18
  90.0%
33
  82.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Mali Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
1.Primary Outcome
Title Number of Participants With Solicited Adverse Events by Immunization and Type
Hide Description Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.
Time Frame Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imovax Rabies Vaccine FMP1/AS02A Vaccine
Hide Arm/Group Description:

1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.

500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
Immunization 1: Any Symptom
8
  40.0%
18
  90.0%
Immunization 1: Local Symptom
4
  20.0%
13
  65.0%
Immunization 1: General Symptom
4
  20.0%
14
  70.0%
Immunization 2: Any Symptom
12
  60.0%
13
  65.0%
Immunization 2: Local Symptom
7
  35.0%
10
  50.0%
Immunization 2: General Symptom
8
  40.0%
12
  60.0%
Immunization 3: Any Symptom
11
  55.0%
11
  55.0%
Immunization 3: Local Symptom
9
  45.0%
8
  40.0%
Immunization 3: General Symptom
5
  25.0%
8
  40.0%
2.Secondary Outcome
Title Geometric Mean Titers for Anti-FMP1 Antibody
Hide Description Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.
Time Frame Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364
Hide Outcome Measure Data
Hide Analysis Population Description
Immune response was measured by anti-FMP1 endpoint titers. Data were obtained on day 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364. Samples collected on vaccination days (days 0, 30, and 60) were collected immediately prior to vaccination.
Arm/Group Title Geometric Mean Titer
Hide Arm/Group Description:
Geometric Mean Titer (GMT)
Overall Number of Participants Analyzed 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: geometric mean titers
Imovax: Pre-Imm 1
3282
(1423 to 7568)
Imovax: Imm 1+14 days
3089
(1332 to 7161)
Imovax: Pre-Imm 2
3485
(1391 to 8728)
Imovax: Imm 2+14 days
4036
(1796 to 9071)
Imovax: Pre-Imm 3
6915
(3148 to 15190)
Imovax: Imm 3+14 days
7051
(3477 to 14300)
Imovax: Imm 3+30 days
6892
(3645 to 13029)
Imovax: Day 180
9089
(3817 to 21645)
Imovax: Day 272
6367
(2743 to 14779)
Imovax: Day 364
5015
(2194 to 11462)
FMP1/AS02A: Pre-Imm 1
5858
(2650 to 12950)
FMP1/AS02A: Imm 1+14 days
7627
(3561 to 16336)
FMP1/AS02A: Pre-Imm 2
8007
(3809 to 16831)
FMP1/AS02A: Imm 2+14 days
20044
(12994 to 30919)
FMP1/AS02A: Pre-Imm 3
26321
(19611 to 35326)
FMP1/AS02A: Imm 3+14 days
35194
(26245 to 47194)
FMP1/AS02A: Imm 3+30 days
37923
(26788 to 53686)
FMP1/AS02A: Day 180
29150
(18301 to 46432)
FMP1/AS02A: Day 272
19518
(11181 to 34072)
FMP1/AS02A: Day 364
14693
(8216 to 26276)
Time Frame Solicited AEs were recorded during each of the 3 eight day follow-up periods after each vaccination and unsolicited AEs were recorded for 12 months
Adverse Event Reporting Description

Solicited AEs were recorded by occurrence of symptoms elicited during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7. Unsolicited AEs were recorded for 12 months. AEs were listed by Vaccine group, per subject, and immunization number (1, 2, or 3).

Grade 1= Easily tolerated; Grade 2= Interferes with daily activities; Grade 3= Prevents daily activities

 
Arm/Group Title Imovax Rabies Vaccine FMP1/AS02A Vaccine
Hide Arm/Group Description

1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

Imovax Rabies Vaccine: Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.

500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

FMP1/AS02A: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.

All-Cause Mortality
Imovax Rabies Vaccine FMP1/AS02A Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Imovax Rabies Vaccine FMP1/AS02A Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      2/20 (10.00%)    
Reproductive system and breast disorders     
Tubal ectopic pregnancy (right side) * 1 [1]  0/20 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Sinusitus * 1 [2]  0/20 (0.00%)  0 1/20 (5.00%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
[1]
Immunization 3
[2]
Immunization 2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Imovax Rabies Vaccine FMP1/AS02A Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      20/20 (100.00%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  2/20 (10.00%)  2 1/20 (5.00%)  1
Malaria * 1  5/20 (25.00%)  5 5/20 (25.00%)  5
Cardiac disorders     
Bradycardia * 1  2/20 (10.00%)  2 0/20 (0.00%)  0
Heart murmur * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Ear and labyrinth disorders     
Otitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Eye disorders     
Lacrimation abnormal * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Pruritus ocular * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Pterygium * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Vision accomodation abnormal * 1  2/20 (10.00%)  2 0/20 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Anus disorder * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Bloody diarrhea * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Constipation * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Diarrhea * 1  3/20 (15.00%)  3 5/20 (25.00%)  5
Dyspepsia * 1  5/20 (25.00%)  5 1/20 (5.00%)  1
Gastritis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Gastroenteritis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Glossitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Nausea * 1  1/20 (5.00%)  1 2/20 (10.00%)  2
Nausea  1  3/20 (15.00%)  3 5/20 (25.00%)  5
Peptic ulcer * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Saliva increased * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Stomatitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Tooth ache * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Tooth caries aggrevated * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Tooth disorder * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Vomiting * 1  0/20 (0.00%)  0 3/20 (15.00%)  3
General disorders     
Asthenia * 1  1/20 (5.00%)  1 2/20 (10.00%)  2
Ataxia * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Fatigue * 1  2/20 (10.00%)  2 3/20 (15.00%)  3
Fever  1  3/20 (15.00%)  3 7/20 (35.00%)  7
Fever * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
Flu like symptoms * 1  5/20 (25.00%)  5 3/20 (15.00%)  3
Malaise * 1  3/20 (15.00%)  3 0/20 (0.00%)  0
Malaise  1  7/20 (35.00%)  7 8/20 (40.00%)  8
Sweating increased * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Swelling  1  15/20 (75.00%)  15 20/20 (100.00%)  20
Infections and infestations     
Bacterial infection * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Conjunctivitis * 1  8/20 (40.00%)  8 2/20 (10.00%)  2
Infection * 1  5/20 (25.00%)  5 10/20 (50.00%)  10
Otitis media * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Rhinitis * 1  8/20 (40.00%)  8 10/20 (50.00%)  10
Injury, poisoning and procedural complications     
Inflammation at injection site * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Injection site reaction * 1  8/20 (40.00%)  8 3/20 (15.00%)  3
Injury * 1  4/20 (20.00%)  4 1/20 (5.00%)  1
Pain at injection site  1  6/20 (30.00%)  6 20/20 (100.00%)  20
Pain at injection site * 1  2/20 (10.00%)  2 0/20 (0.00%)  0
Site mass at injection site * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Metabolism and nutrition disorders     
Thirst * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arm motion limitation  1  0/20 (0.00%)  0 6/20 (30.00%)  6
Arthralgia * 1  0/20 (0.00%)  0 3/20 (15.00%)  3
Back pain * 1  3/20 (15.00%)  3 2/20 (10.00%)  2
Chills  1  4/20 (20.00%)  4 8/20 (40.00%)  8
Chills * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Joint pain  1  1/20 (5.00%)  1 7/20 (35.00%)  7
Muscle weakness * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
Myalgia  1  0/20 (0.00%)  0 11/20 (55.00%)  11
Myalgia * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Rigors * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Torticollis * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Nervous system disorders     
Dizziness * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Headache * 1  4/20 (20.00%)  4 6/20 (30.00%)  6
Headache  1  8/20 (40.00%)  8 20/20 (100.00%)  20
Neuralgia * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Taste perversion * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Psychiatric disorders     
Insomnia * 1  1/20 (5.00%)  1 2/20 (10.00%)  2
Renal and urinary disorders     
Dysuria * 1  3/20 (15.00%)  3 0/20 (0.00%)  0
Urinary tract infection * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Reproductive system and breast disorders     
Leukorrhea * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Pregnancy * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Bradypnea * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Bronchitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Coughing * 1  1/20 (5.00%)  1 2/20 (10.00%)  2
Laryngitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Pharyngitis * 1  4/20 (20.00%)  4 3/20 (15.00%)  3
Skin and subcutaneous tissue disorders     
Eczema * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Pruritus * 1  1/20 (5.00%)  1 2/20 (10.00%)  2
Rash maculo-papular * 1  3/20 (15.00%)  3 1/20 (5.00%)  1
Skin ulceration * 1  2/20 (10.00%)  2 1/20 (5.00%)  1
Urticaria * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders     
Hemorrhoids * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Hot flushes * 1  10/20 (50.00%)  10 20/20 (100.00%)  20
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
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: Mahamadou A. Thera, MD MPH
Organization: University of Bamako Faculty of Medicine, Mali
Phone: 223-222-1809
ClinicalTrials.gov Identifier: NCT00308061     History of Changes
Other Study ID Numbers: WRAIR 1029
NIH DMID 02-184
Univ of Maryland IRB 0303311
HSRRB A-12093
NIAID IRB 177
First Submitted: March 24, 2006
First Posted: March 28, 2006
Results First Submitted: January 4, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017