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

Completed · Phase 2

Conditions studied: Malaria

In brief

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.

Key facts

Study ID

NCT03162614

Run by

GlaxoSmithKline

People needed

154

Starts

2017-05-24

Expected to finish

2018-09-24

Last updated by the study team

2020-10-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing of any study specific procedure.
• A male or female between, and including, 18 and 55 years of age at the time of enrolment.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Available to participate for the duration of the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test at enrolment, and
• has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series and/or malaria challenge.

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Chronic use of antibiotics with antimalarial effects.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Documented HIV-positive subject.
• Previous vaccination against malaria.
• History of malaria chemoprophylaxis within 60 days prior to vaccination.
• Any history of malaria (for the vaccine groups).
• Planned travel to malaria endemic areas during the study period.
• History of splenectomy.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• History of anaphylaxis post-vaccination.
• Hypersensitivity to latex.
• History of any reaction or hypersensitivity likely to be exacerbated by chloroquine.
• History of psoriasis and porphyria, which may be exacerbated after chloroquine treatment.
• Current use of medications known to cause drug reactions to chloroquine.
• History of severe reactions to mosquito bites.
• Major congenital defects.
• Serious chronic illness.

Where it is running

• GSK Investigational Site — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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