Malaria, Falciparum Clinical Trial
Official title:
Phase I/IIa Safety, Immunogenicity, and Preliminary Efficacy of an Administration Schedule of FMP1 and SmithKlineBeecham Biologicals' Candidate Malaria Vaccine RTS,S Each Adjuvanted With SBAS2, Given Concomitantly in Separate Injections
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS,
combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are
safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines
can prevent malaria infection.
The RTS,S vaccine contains a malaria protein in combination with a portion of the
commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria
protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are
done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after
the 3rd vaccination.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02329301 -
Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia
|
N/A | |
| Recruiting |
NCT01944189 -
Artemether/ Lumefantrine: A Study of the Effect of Local Food on Pharmacokinetics and Population Pharmacokinetics
|
Phase 4 | |
| Terminated |
NCT01442168 -
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
|
Phase 1/Phase 2 | |
| Completed |
NCT01325974 -
Time to Become Negative of Three Rapid Diagnostic Tests for Malaria
|
N/A | |
| Terminated |
NCT00374205 -
Randomized Trial on Effectiveness of ACTs in Ghana
|
Phase 4 | |
| Completed |
NCT00375128 -
Sporozoite Challenge of Polyprotein Vaccinees
|
Phase 1/Phase 2 | |
| Completed |
NCT04609098 -
Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)
|
Phase 2 | |
| Completed |
NCT02851108 -
Methylene Blue Against Falciparum Malaria in Burkina Faso
|
Phase 2 | |
| Completed |
NCT02434952 -
Safety and Tolerability of Low Dose Primaquine
|
Phase 4 | |
| Terminated |
NCT02281344 -
MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
|
Phase 1 | |
| Completed |
NCT01213966 -
Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection
|
Phase 2 | |
| Completed |
NCT00479206 -
Artemisinin Resistance in Cambodia
|
N/A | |
| Completed |
NCT00126906 -
Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi
|
N/A | |
| Completed |
NCT01019408 -
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
|
Phase 4 | |
| Completed |
NCT00529867 -
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
|
Phase 4 | |
| Completed |
NCT00137553 -
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
|
Phase 4 | |
| Completed |
NCT02637128 -
In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria
|
Phase 4 | |
| Completed |
NCT01222962 -
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers
|
Phase 1 | |
| Unknown status |
NCT00152204 -
The Community Effectiveness of IPTi in Southern Tanzania
|
Phase 3 | |
| Terminated |
NCT00084240 -
Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia
|
Phase 2/Phase 3 |