Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

November 6, 2020

Primary Completion Date

June 22, 2022

Study Completion Date

August 17, 2022

Conditions
Plasmodium Falciparum
Interventions
BIOLOGICAL

Malaria Vaccine RTS,S/AS01E

RTS,S/AS01E vaccine 0.5 mL, containing 25 μg protein comprising circumsporozoite protein (CS) and hepatitis B surface antigen (RTS,S), 25 μg monophosphoryl lipid (AMPL), 25 μg Quillaja saponaria 21 (QS21) in a liposomal formulation) for the first two immunizations. One-fifth dose RTS,S/AS01E vaccine was used for the third immunization.

BIOLOGICAL

Abhayrab rabies vaccine

Abhayrab rabies vaccine, 0.5 mL, contains 2.5 IU rabies antigen.

DRUG

Dihydroartemisinin-piperaquine (DHA/Pip)

"Dihydroartemisinin (120 mg or 160 mg based on weight) and piperaquine tetraphosphate (960 mg or 1280 mg based on weight) mg) administered once a day for 3 days.~DHA/Pip is a long acting anti-malarial used to clear asexual stage and young gametocyte parasites."

DRUG

Artemether / Lumefantrine

"Artemether (80 mg) and lumefantrine (480 mg) administered twice a day for 3 days.~Coartem is a short-acting artemisinin combination therapy used to provide clearance of blood stage parasites in order to establish a clean baseline for determination of vaccine efficacy."

DRUG

Primaquine

One dose of 15 mg primaquine. Low dose primaquine (LD PQ) is used to clear mature gametocytes of P. falciparum.

Trial Locations (1)

40100

Lucas O Tina, Kisumu

All Listed Sponsors
collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Kenya Medical Research Institute

OTHER

collaborator

FHI Clinical SA Proprietary Limited

INDUSTRY

collaborator

DF/Net

UNKNOWN

lead

PATH

OTHER