Phase 2
N=400
Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
Malaria, Falciparum
Bottom Line
View on ClinicalTrials.gov: NCT00223990 ↗Enrolled (actual)
400
Serious AEs
5.8%
Results posted
May 2020
Primary outcome: Primary: Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population — 107; 121; 25; 29 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FMP1/AS02A (Biological); RabAvert (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Apr 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population |
107; 121; 25; 29; 68; 80 | — |
| SECONDARY Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population |
85; 86; 17; 13; 49; 50 | — |
| SECONDARY Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population |
140; 9; 51; 1; 61; 11 | — |
| SECONDARY Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population |
137; 8; 50; 1; 61; 10 | — |
| SECONDARY Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population |
14; 7; 7; 3; 4; 0 | — |
| SECONDARY Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population |
13; 6; 7; 2; 4; 0 | — |
| SECONDARY Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization |
195; 85; 197; 197; 16; 8 | — |
| SECONDARY Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) |
157; 22; 139; 9; 82; 16 | — |
| SECONDARY Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) |
160; 24; 142; 10; 83; 17 | — |
Summary
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum.
Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions.
This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination.
One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).
Eligibility Criteria
Inclusion Criteria
All subjects must satisfy the following criteria at study entry:
- A healthy male or female child, 12 to 47 months of age on the day of screening
- Written informed consent obtained from at least one parent/guardian before study start
- Available to participate for the study duration (about 14 months)
Exclusion Criteria
- Acute disease at the time of entry into the study that in the opinion of the investigator may pose a threat to the subject
- Prior receipt of a rabies vaccine or any investigational vaccine
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed)
- Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid
- Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S/AS02A)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV test will be performed as part of this study.)
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine components, such as eggs
- History of surgical splenectomy
- Administration of immunoglobulins, blood transfusions, or any other blood products within the six months preceding the first dose of study vaccine or planned administration during the study period
- Simultaneous participation in any other clinical trial
- Acute or chronic cardiovascular, pulmonary, hepatic, or renal condition that in the opinion of the PI, may increase the risk to the subject from participating in the study
- Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject
Data sourced from ClinicalTrials.gov (NCT00223990). 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.