CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
RTS,S/AS01E (SB257049)biological
Likely dose
Not stated in 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/NCT03824236
NCT03824236Phase 2Completed
CompareCT.gov

Efficacy, Immunogenicity and Safety Study Evaluating a Fractional (Fx) Booster Dose of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults

GlaxoSmithKline·interventional·Posted Jan 31, 2019·Updated Aug 14, 2020

In Brief

A Phase 2 clinical trial evaluating RTS,S/AS01E (SB257049) for Malaria. Completed, enrolled 61 participants across 1 site.

Detailed Summary

MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study (follow-up to MALARIA-092 \[NCT03162614\] study) is to evaluate if protection can be extended with an additional Fx booster dose and if unprotected subjects can be protected following a Fx booster dose. In this booster study, subjects from MALARIA-092 (NCT03162614) study who completed vaccination and challenge will receive a Fx booster dose of RTS,S/AS01E and undergo a second controlled human malaria infection (CHMI) three to four weeks after vaccination. Additionally, subjects will be newly enrolled and will only undergo the sporozoite challenge as infectivity controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited States
CollaboratorsPATH

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 31, 2019
Enrollment StartFeb 5, 2019
Primary CompletionApr 30, 2019
Study CompletionSep 26, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.4 years ago

Interventions

RTS,S/AS01E (SB257049)biological

Subjects from the P-Fx and NP-Fx groups will receive one Fx booster dose of RTS,S/AS01E at Day 1.