Phase 2
N=400
Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali
Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00460525 ↗Enrolled (actual)
400
Serious AEs
2.5%
Results posted
Aug 2010
Primary outcome: Primary: Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination — 0; 5; 0; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FMP2.1/AS02A (Biological); Rabies Vaccine (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination |
0; 5; 0; 12; 3; 25 | — |
| PRIMARY Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination. |
0; 0; 1; 5; 1; 10 | — |
| PRIMARY Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination. |
1; 0; 2; 6; 0; 3 | — |
| PRIMARY Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination |
7; 4; 0; 0; 5; 5 | — |
| PRIMARY Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination |
1; 2; 0; 1; 1; 1 | — |
| PRIMARY Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination |
7; 1; 0; 0; 8; 7 | — |
| PRIMARY Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C. |
201; 199; 1; 0; 4; 1 | 0.175 |
| PRIMARY Number of Subjects Reporting Serious Adverse Events |
2; 8 | — |
| SECONDARY Incidence Density of Clinical Malaria Episode |
1.187263; 0.949683 | 0.068 |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0 |
430.4; 393.1 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30. |
403.7; 21248.7 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60. |
512.2; 98199.0 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90. |
781.8; 188449.1 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150. |
1202.9; 100746.5 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240. |
774.6; 65031.7 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364 |
505.0; 42596.8 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547 |
1589.3; 81205.1 | — |
| SECONDARY Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730 |
636.5; 40605.3 | — |
Summary
Malaria is a disease that affects many people in Africa. Malaria is caused by germs 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.
Eligibility Criteria
Inclusion Criteria
- Age 1-6 years inclusive at the time of screening
- Residing in Bandiagara town
- Appear to be in generally good health based on clinical and laboratory investigation
- Separate written informed consent obtained from the parent/guardian before screening and study start, respectively
- Available to participate in follow-up for the duration of study (26 months)
Exclusion Criteria
- Previous vaccination with an investigational vaccine or a rabies vaccine
- 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
- 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.
- Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Confirmed or suspected autoimmune disease
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
- History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
- History of allergy to tetracycline, doxycycline, nickel, Imidazole, eggs, neomycin, chlortetracycline or amphotericin B
- History of splenectomy
- Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory = 49.6 U/L)
- 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)
- Laboratory evidence of hematologic disease (absolute leukocyte count 15,300/mm^3, absolute lymphocyte count <2,300 mm^3, platelet count <133,000/mm^3, or hemoglobin <9.0 g/dL)
- Hepatitis B surface antigen positive
- Chronic skin condition that could interfere with vaccine site reactogenicity assessment
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period
- Simultaneous participation in any other interventional clinical trial
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00460525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.