ClinicalTrials.gov

History of Changes for Study: NCT00460525
Phase 2 FMP2.1 Trial in Mali
Latest version (submitted October 11, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 12, 2007 None (earliest Version on record)
2 April 26, 2007 Study Status
3 May 10, 2007 Recruitment Status, Study Status and Contacts/Locations
4 May 11, 2007 Sponsor/Collaborators and Study Status
5 May 17, 2007 References and Study Status
6 May 24, 2007 Study Status
7 May 31, 2007 Study Status
8 June 14, 2007 Study Status
9 June 21, 2007 Study Status
10 June 22, 2007 Study Status
11 June 28, 2007 Study Status
12 July 5, 2007 Sponsor/Collaborators and Study Status
13 July 12, 2007 Study Status
14 July 19, 2007 Study Status
15 July 26, 2007 Study Status
16 August 2, 2007 Study Status
17 August 9, 2007 Recruitment Status, Study Status and Contacts/Locations
18 August 16, 2007 Study Status
19 August 23, 2007 Study Status
20 September 6, 2007 Sponsor/Collaborators and Study Status
21 September 10, 2007 Sponsor/Collaborators and Study Status
22 September 13, 2007 Study Status
23 September 20, 2007 Study Status
24 September 27, 2007 Study Status
25 October 2, 2007 Study Status
26 October 4, 2007 Study Status
27 October 11, 2007 Study Status
28 October 18, 2007 Study Status
29 October 25, 2007 Study Status
30 November 1, 2007 Study Status
31 November 8, 2007 Study Status
32 November 15, 2007 Study Status
33 November 20, 2007 Study Status
34 November 29, 2007 Sponsor/Collaborators and Study Status
35 December 6, 2007 Sponsor/Collaborators and Study Status
36 December 10, 2007 Study Status
37 December 13, 2007 Study Status
38 December 19, 2007 Study Status
39 January 10, 2008 Sponsor/Collaborators and Study Status
40 January 17, 2008 Sponsor/Collaborators and Study Status
41 January 24, 2008 Study Status
42 January 31, 2008 Study Status
43 February 7, 2008 Study Status
44 February 14, 2008 Study Status
45 February 21, 2008 Study Status
46 February 28, 2008 Study Status
47 March 6, 2008 Study Status
48 March 13, 2008 Study Status
49 March 20, 2008 Study Status
50 March 27, 2008 Study Status
51 April 3, 2008 Study Status
52 April 10, 2008 Study Status
53 May 1, 2008 Study Status, Eligibility, Arms and Interventions and Conditions
54 May 8, 2008 Study Status
55 May 15, 2008 Study Status
56 May 22, 2008 Study Status
57 May 29, 2008 Study Status
58 June 5, 2008 Study Status
59 June 12, 2008 Study Status
60 June 19, 2008 Study Status
61 June 26, 2008 Study Status
62 July 3, 2008 Study Status
63 July 10, 2008 Study Status
64 July 17, 2008 Study Status
65 July 24, 2008 Study Status, Arms and Interventions, Study Design, Outcome Measures and Sponsor/Collaborators
66 July 31, 2008 Study Status
67 August 7, 2008 Study Description and Study Status
68 August 14, 2008 Study Status
69 August 20, 2008 Study Status
70 August 28, 2008 Study Status
71 September 4, 2008 Study Status
72 September 11, 2008 Study Status
73 September 16, 2008 Study Status
74 September 18, 2008 Study Status
75 September 25, 2008 Study Status
76 September 26, 2008 Study Status
77 October 2, 2008 Study Status
78 October 9, 2008 Study Status
79 October 16, 2008 Study Status
80 October 23, 2008 Study Status
81 October 24, 2008 Study Status
82 October 30, 2008 Study Status
83 November 6, 2008 Study Status
84 November 13, 2008 Study Status
85 November 20, 2008 Study Status
86 November 26, 2008 Study Status
87 December 4, 2008 Study Status
88 December 11, 2008 Study Status
89 December 18, 2008 Study Status
90 December 26, 2008 Study Status
91 December 31, 2008 Study Status
92 January 8, 2009 Study Status
93 January 15, 2009 Study Status
94 January 22, 2009 Study Status
95 January 29, 2009 Study Status
96 February 5, 2009 Study Status
97 February 12, 2009 Study Status, Eligibility, Outcome Measures, Arms and Interventions, Study Description and Study Identification
98 February 19, 2009 Study Status
99 February 26, 2009 Study Status
100 March 5, 2009 Study Status
101 March 12, 2009 Study Status
102 March 19, 2009 Study Status
103 March 26, 2009 Study Status
104 April 2, 2009 Study Status
105 April 9, 2009 Study Status
106 April 16, 2009 Study Status
107 April 23, 2009 Study Status
108 April 30, 2009 Study Status
109 May 1, 2009 Study Status
110 May 7, 2009 Study Status
111 May 14, 2009 Study Status
112 May 18, 2009 Sponsor/Collaborators and Study Status
113 May 21, 2009 Sponsor/Collaborators and Study Status
114 May 28, 2009 Sponsor/Collaborators and Study Status
115 June 4, 2009 Study Status
116 June 11, 2009 Study Status
117 June 18, 2009 Sponsor/Collaborators and Study Status
118 June 25, 2009 Study Status
119 July 2, 2009 Study Status
120 July 9, 2009 Study Status
121 July 16, 2009 Study Status
122 July 23, 2009 Study Status
123 July 30, 2009 Study Status
124 August 6, 2009 Study Status
125 August 13, 2009 Study Status
126 August 27, 2009 Arms and Interventions, Study Design, Study Description, Study Status and Study Identification
127 September 3, 2009 Study Status
128 September 10, 2009 Study Status
129 September 17, 2009 Study Status
130 September 24, 2009 Study Status
131 October 1, 2009 Study Status
132 October 8, 2009 Recruitment Status and Study Status
133 October 15, 2009 Study Status
134 October 22, 2009 Study Status
135 October 29, 2009 Sponsor/Collaborators and Study Status
136 November 5, 2009 Sponsor/Collaborators and Study Status
137 November 12, 2009 Study Status
138 November 19, 2009 Study Status
139 November 25, 2009 Study Status
140 December 3, 2009 Study Status
141 December 10, 2009 Study Status
142 December 17, 2009 Study Status
143 December 23, 2009 Study Status
144 December 31, 2009 Study Status and Study Identification
145 January 7, 2010 Study Status and Study Identification
146 January 14, 2010 Study Status
147 January 21, 2010 Study Status
148 January 28, 2010 Study Status
149 February 4, 2010 Study Status
150 February 11, 2010 Study Status
151 February 18, 2010 Study Status
152 February 25, 2010 Study Status
153 March 4, 2010 Study Status
154 March 11, 2010 Study Status
155 March 18, 2010 Study Status
156 March 25, 2010 Study Status
157 April 1, 2010 Study Status
158 April 8, 2010 Study Status
159 April 15, 2010 Study Status
160 April 22, 2010 Study Status and Study Identification
161 April 29, 2010 Study Status
162 May 6, 2010 Study Identification and Study Status
163 May 13, 2010 Study Status
164 May 20, 2010 Study Status
165 May 27, 2010 Study Status
166 June 3, 2010 Study Status
167 August 4, 2010 Outcome Measures, Study Status, Results and Sponsor/Collaborators
168 August 9, 2010 Adverse Events, Outcome Measures and Study Status
169 August 19, 2010 Study Status and Sponsor/Collaborators
170 August 26, 2010 Sponsor/Collaborators and Study Status
171 September 2, 2010 Sponsor/Collaborators and Study Status
172 September 16, 2010 Study Status
173 October 28, 2010 Study Status
174 November 11, 2010 Study Status
175 December 16, 2010 Study Status
176 December 30, 2010 Study Status
177 January 6, 2011 Study Status
178 January 13, 2011 Study Status
179 February 10, 2011 Adverse Events, Outcome Measures and Study Status
180 June 9, 2011 Sponsor/Collaborators and Study Status
181 October 12, 2011 Sponsor/Collaborators, Study Identification, Study Design and Study Status
182 October 18, 2011 Study Status
183 June 1, 2012 Sponsor/Collaborators, Study Identification, Study Design, Study Status, Contacts/Locations and Oversight
184 August 9, 2012 Study Status
185 May 18, 2015 Sponsor/Collaborators, Outcome Measures, Baseline Characteristics and Study Status
186 October 11, 2018 Study Status, Outcome Measures, Sponsor/Collaborators
Comparison Format:

Scroll up to access the controls

Study NCT00460525
Submitted Date:  April 12, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 07-0003
Brief Title: Phase 2 FMP2.1 Trial in Mali
Official Title: Randomized, Controlled Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the AMA-1 Malaria Vaccine FMP2.1/AS02A Versus Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali
Secondary IDs: Malaria-056 (110060)
Open or close this module Study Status
Record Verification: April 2007
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: April 12, 2007
First Submitted that
Met QC Criteria:
April 12, 2007
First Posted: April 16, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 12, 2007
Last Update Posted: April 16, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: Malaria is a disease that affects many people in Africa. Malaria is caused by germs that are spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of children who get malaria after receiving a vaccine for rabies (an approved vaccine that does not prevent malaria). The children will be assigned to one of the vaccine groups by chance. Participants and doctors will not know which vaccine was given. Study participants will include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3 vaccine doses, by injection, to their upper arm. Study procedures will include physical exams and several blood samples. Participants will be involved in the study for 26 months.
Detailed Description: This is a randomized, controlled clinical trial to evaluate the efficacy, safety and immunogenicity of the AMA-1 malaria vaccine FMP2.1/AS02A using rabies vaccine as a control in healthy children 1-6 years old in Bandiagara, Mali. This phase 2 study is linked to Division of Microbiology and Infectious Diseases (DMID) protocol 05-0146, which is a phase 1 dose escalation trial at the same site in the same population. In this study, 400 subjects will be randomized in a 1:1 ratio to receive either 50 micrograms of FMP2.1 in 0.5 mL AS02A or rabies vaccine. Immunizations will be given on days 0, 30 and 60. Solicited adverse events will be recorded on the days of immunization and at 1, 2, 3 and 7 days after each immunization. Unsolicited adverse events will be recorded for 30 days after each immunization. Passive case detection will be used to capture clinical malaria episodes and adverse events including serious adverse events, and will occur by continuous availability of clinical care in a population with high utilization of this care. Active surveillance will be used to capture malaria infections and adverse events including serious adverse events. For active case detection, following the third dose, participants will be followed monthly for 6 months and then at 12, 18 and 24 months after randomization, for clinical assessment, malaria smear and hemoglobin. Routine monthly malaria smears will not be read immediately unless symptoms are present. Children will be followed for 2 years after the first immunization. Sera will be collected for anti-FMP2.1 antibody titers on the days of immunization and 1, 3, 6, 8, 12, 18 and 24 months after the first immunization. PBMCs will be collected on the days of immunization, 30 days after the third immunization and 8, 12, 18 and 24 months after the first immunization. The study Final Report will be based on data collected up to 6 months after the assigned date of the third immunization. A supplemental report will include data from the entire 24-month observation period. Primary study objectives are to: determine the efficacy of FMP2.1/AS02A in children aged 1-6 years against first clinical malaria episodes (axillary temperature of greater than or equal to 37.5 degrees C and parasitemia of greater than or equal to 2500/cubic mm) occurring between randomization and 6 months after the assigned date of the third immunization; and assess the safety of the vaccine in children aged 1-6 years. Secondary study objectives are to: describe the dynamics of anti-AMA-1 antibody responses in recipients of the malaria vaccine compared to natural responses in the control group; determine whether serum anti-AMA-1 IgG titer by ELISA 1 month after the third immunization correlates with protection against clinical malaria episode; measure allele-specific efficacy against parasites with AMA-1 genotypes homologous to and heterologous to the 3D7 clone of P. falciparum; determine vaccine efficacy against clinical malaria episodes occurring between randomization and 6 months after the assigned date of the third immunization; and if efficacy is observed based on the primary endpoint, to determine vaccine efficacy against first clinical malaria episode and all clinical episodes (using increasing parasitemia thresholds) occurring during 2 years after randomization.
Open or close this module Conditions
Conditions: Plasmodium Falciparum Malaria
Keywords: Malaria, Mali, Children, FMP2.1/AS02A, Plasmodium falciparum
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 400
Open or close this module Arms and Interventions
Intervention Details:
Biological: FMP2.1/AS02A
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age: 6 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. Age 1-6 years inclusive at the time of screening
  2. Residing in Bandiagara town
  3. Appear to be in generally good health based on clinical and laboratory investigation
  4. Separate written informed consent obtained from the parent/guardian before screening and study start, respectively
  5. Available to participate in follow-up for the duration of study (26 months)

Exclusion Criteria:

  1. Previous vaccination with an investigational vaccine or a rabies vaccine
  2. Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
  3. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This exclusion includes any dose level of oral steroids or inhaled steroids, but not topical steroids.
  4. Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  5. Confirmed or suspected autoimmune disease
  6. History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
  7. History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
  8. History of allergy to tetracycline, doxycycline, nickel, Imidazole, eggs, neomycin, chlortetracycline or amphotericin B
  9. History of splenectomy
  10. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory = 49.6 U/L)
  11. Laboratory evidence of renal disease (serum or plasma creatinine greater than 62 micro mol/L), or more than trace protein or blood on urine dipstick testing)
  12. Laboratory evidence of hematologic disease (absolute leukocyte count <5,300/cubic mm or >15,300/cubic mm, absolute lymphocyte count <2,300 cubic mm, platelet count <133,000/cubic mm, or hemoglobin <9.0 g/dL)
  13. Hepatitis B surface antigen positive
  14. Chronic skin condition that could interfere with vaccine site reactogenicity assessment
  15. Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period
  16. Simultaneous participation in any other interventional clinical trial
  17. Acute or chronic pulmonary, cardiovascular, hepatic (including hepatomegaly), renal or neurological condition, severe malnutrition, or any other clinical findings that in the opinion of the PI may increase the risk of participating in the study
  18. Other condition that in the opinion of the Principal Investigator (PI) would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Open or close this module Contacts/Locations
Central Contact Person: Mahamadou Thera
Telephone: + 223-222 81 09
Locations: Mali
University of Bamako, Malaria Research and Training Center
Bamako, Mali
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services