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FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
University of Maryland
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00349713
First received: July 6, 2006
Last updated: April 25, 2017
Last verified: April 2017
Results First Received: December 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Malaria
Plasmodium Falciparum Malaria
Interventions: Biological: FMP2.1/AS02A
Biological: Rabies vaccine (RabAvert)

  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
175 participants were screened; 115 were excluded; 60 subjects were randomized in a 2:1 ratio into 2 cohorts

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
Cohort 1: FMP2.1 / AS02A

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

Cohort 2: FMP2.1 / AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

Cohorts 1 and 2: Rabies Vaccine (RabAvert)

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine


Participant Flow:   Overall Study
    Cohort 1: FMP2.1 / AS02A   Cohort 2: FMP2.1 / AS02A   Cohorts 1 and 2: Rabies Vaccine (RabAvert)
STARTED   20   20   20 
COMPLETED   20   20   20 
NOT COMPLETED   0   0   0 



  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.
No text entered.

Reporting Groups
  Description
Cohort 1: 25ug FMP2.1 / AS02A

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

Cohort 2: 50ug FMP2.1 / AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

Cohorts 1 and 2: Rabies Vaccine (RabAvert)

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Total Total of all reporting groups

Baseline Measures
   Cohort 1: 25ug FMP2.1 / AS02A   Cohort 2: 50ug FMP2.1 / AS02A   Cohorts 1 and 2: Rabies Vaccine (RabAvert)   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   20   60 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      20 100.0%      20 100.0%      60 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4  20.0%      4  20.0%      3  15.0%      11  18.3% 
Male      16  80.0%      16  80.0%      17  85.0%      49  81.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Mali   20   20   20   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety and Reactogenicity (SAEs and AEs)   [ Time Frame: 12 months ]

2.  Secondary:   Antibody Response to FMP2.1 Over Time   [ Time Frame: 90 Days ]

3.  Secondary:   Anti-AMA1 Log Antibody Titers Over Time   [ Time Frame: 90 Days ]

4.  Secondary:   Geometric Mean Antibody Titers Over Time   [ Time Frame: 90 Days ]

5.  Secondary:   Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time   [ Time Frame: 90 Days ]


  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: Mahamadou A. Thera, MD, MPH, Professor
Organization: University of Bamako
phone: 223-20-22-81-09
e-mail: mthera@icermaili.org



Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00349713     History of Changes
Other Study ID Numbers: 04-031
N01AI085346-006 ( U.S. NIH Grant/Contract )
N01AI085346-005 ( U.S. NIH Grant/Contract )
N01AI085346-000 ( U.S. NIH Grant/Contract )
102231 ( Malaria-037) ( Other Identifier: GSK )
HSRRB A-12855 ( Other Identifier: USAMRMC )
Study First Received: July 6, 2006
Results First Received: December 20, 2016
Last Updated: April 25, 2017