Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

May 24, 2017

Primary Completion Date

July 9, 2018

Study Completion Date

September 24, 2018

Conditions
Malaria
Interventions
BIOLOGICAL

RTS,S/AS01E

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

BIOLOGICAL

RTS,S/AS01B

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

PROCEDURE

Sporozoite-infected mosquitoes challenge.

"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."

Trial Locations (1)

20910

GSK Investigational Site, Silver Spring

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The PATH Malaria Vaccine Initiative (MVI)

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT03162614 - Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults | Biotech Hunter | Biotech Hunter