Phase 1
N=100
Phase I Pediatric FMP2.1/AS02A Trial in Mali
Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00358332 ↗Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Mar 2009
Primary outcome: Primary: Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- FMP2.1/AS02A (Biological); Rabies vaccine (RabAvert) (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60. |
4; 7; 10; 2 | — |
| PRIMARY Number of Subjects Spontaneously Reporting Any Serious Adverse Event. |
1; 1; 0; 2 | — |
| PRIMARY Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. |
11; 27; 27; 6; 13; 28 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0 |
2.73; 2.70; 3.04; 2.66 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30 |
4.09; 4.20; 4.31; 2.57 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60 |
4.78; 4.98; 4.97; 2.53 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90 |
4.93; 5.22; 5.05; 2.41 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180 |
4.53; 4.73; 4.57; 2.15 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272. |
4.25; 4.43; 4.51; 2.13 | — |
| SECONDARY Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364 |
4.36; 4.68; 4.42; 2.56 | — |
Summary
The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage. This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved. During the study, the child's health will be checked in the clinic and during home visits. Children may participate for about 14 months, and blood will be taken from each child throughout the study. If the child becomes sick from malaria, he/she will be treated. Information from this study may be used to develop a malaria vaccine that will help control the disease.
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 (14 months).
Exclusion Criteria
- Previous vaccination with an investigational vaccine or a rabies vaccine.
- Use of a 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 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 or Imidazole.
- 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 creatinine greater than the upper limit of normal of the testing laboratory = 0.5 mg/dL (44.2 micromol/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).
- 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, renal or neurological condition, severe malnutrition, or any other clinical findings that in the opinion of the Principal Investigator (PI) may increase the risk of participating in the study.
- Other condition that in the opinion of the 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 (NCT00358332). 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.