CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
RTS,S/AS01E +2 morebiological
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/NCT03162614
NCT03162614Phase 2Completed
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Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Various Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults

GlaxoSmithKline·interventional·Posted May 22, 2017·Updated Oct 27, 2020

In Brief

A Phase 2 clinical trial evaluating RTS,S/AS01E, RTS,S/AS01B, and 1 other intervention for Malaria. Completed, enrolled 154 participants across 1 site.

Detailed Summary

This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study is to investigate whether changes in dosing schedule are associated with increased or equivalent protection, and to evaluate the immune mechanisms associated with vaccine efficacy under varying dosing schedules.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited States
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 22, 2017
Enrollment StartMay 24, 2017
Primary CompletionJul 9, 2018
Study CompletionSep 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.1 years ago

Interventions

RTS,S/AS01Ebiological

Subjects will receive intramuscular injection of RTS,S/AS01E.

RTS,S/AS01Bbiological

Subjects will receive intramuscular injection of RTS,S/AS01B.

Sporozoite-infected mosquitoes challenge.procedure

Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed. The challenge occurs approximately 90 days (three months) after the last vaccination. Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.