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

Summary

The main goal of this study is to assess the efficacy of RTS,S/AS01E, a candidate vaccine against malaria caused by Plasmodium falciparum (P. falciparum), in adults positive for P. falciparum at the start of the study, but treated with anti-malarial medications to clear the parasite before receiving multiple doses of the vaccine. The goal is to overcome the reduced vaccine efficacy (hypo-responsiveness to the vaccine) reported in actively or chronically infected adults.

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.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• GlaxoSmithKline

  collaborator INDUSTRY

• Kenya Medical Research Institute

  collaborator OTHER

• FHI Clinical SA Proprietary Limited

  collaborator INDUSTRY

• DF/Net

  collaborator UNKNOWN

• PATH

  lead OTHER

Principal Investigators

• Lucas O Tina, MD, MTM&H · Kombewa Clinical Research Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-06

Primary Completion

2022-06-22

Completion

2022-08-17

Countries

• Kenya

Study Locations