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
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资源简介:
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.
提供机构:
Vivli
创建时间:
2021-11-08



