CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 620 enrolled
Drug / intervention
Malaria Vaccine RTS,S/AS01E +4 morebiological
Likely dose
Malaria Vaccine RTS,S/AS01E 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04661579
NCT04661579Phase 2Completed
CompareCT.gov

A Phase 2b Randomized, Open-label, Controlled, Single Center Study in Plasmodium Falciparum-infected and Uninfected Adults Age 18-55 Years Old in Kenya to Evaluate the Efficacy of the Delayed, Fractional Dose RTS,S/AS01E Malaria Vaccine in Subjects Treated With Artemisinin Combination Therapy Plus Primaquine

PATH·interventional·Posted Dec 10, 2020·Updated Jul 19, 2024

In Brief

A Phase 2 clinical trial evaluating Malaria Vaccine RTS,S/AS01E, Abhayrab rabies vaccine, and 3 other interventions for Plasmodium Falciparum. Completed, enrolled 620 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasmodium Falciparum
CountriesKenya
CollaboratorsWalter Reed Army Institute of Research (WRAIR), GlaxoSmithKline, Kenya Medical Research Institute, FHI Clinical SA Proprietary Limited, DF/Net

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 10, 2020
Enrollment StartNov 6, 2020
Primary CompletionJun 22, 2022
Study CompletionAug 17, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.6 years ago

Interventions

Malaria Vaccine RTS,S/AS01Ebiological

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.

Abhayrab rabies vaccinebiological

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

Dihydroartemisinin-piperaquine (DHA/Pip)drug

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.

Artemether / Lumefantrinedrug

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.

Primaquinedrug

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