A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 55
Updated:2/23/2019
Start Date:February 5, 2019
End Date:September 12, 2019
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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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

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.


Inclusion Criteria:

Only for subjects from MALARIA-092 study (NCT03162614):

• Subjects vaccinated and having undergone sporozoite challenge during the primary study
(MALARIA-092 [NCT03162614]).

For all subjects:

- 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 any
study-specific procedure.

- 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.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- Has practiced adequate contraception for 30 days prior to Day 1, and has agreed
to continue adequate contraception during the entire treatment period and for two
months after malaria challenge (only for subjects from the MALARIA-092 study
[NCT03162614]).

- Has practiced adequate contraception for 30 days prior to malaria challenge, and
has agreed to continue adequate contraception up to two months after malaria
challenge (only for the infectivity control subjects).

- Has a negative pregnancy test at enrollment.

For the infectivity control subjects:

• Male or female subjects between, and including, 18 and 55 years of age.

Exclusion Criteria:

For all subjects except the infectivity control subjects:

- Any medical condition that in the judgment of the investigator would make
intramuscular injection unsafe.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine.

- History of anaphylaxis post-vaccination.

For all subjects:

- Use of any investigational or non-registered product other than the study vaccine
during the period starting 30 days before Day 1 (Day -29 to Day 1) (for P-Fx and NP-Fx
groups)/before the malaria challenge (for infectivity control subjects), or planned
use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs during
the period starting six months prior to Day 1 (for P-Fx and NP-Fx groups) or malaria
challenge (for infectivity control subjects). 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 anti-malarial effects.

- Planned administration/administration of a vaccine not foreseen by the study protocol
in the period within seven days of Day 1 (for P-Fx and NP-Fx groups) or the malaria
challenge (for infectivity control subjects).

- 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 Human Immunodeficiency Virus, Hepatitis B surface antigen or
Hepatitis C Virus.

- Planned travel to malaria endemic areas during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- History of any reaction or hypersensitivity that would prevent the subject from
utilizing all of the following: chloroquine, atovaquone/proguanil,
artemether/lumefantrine.

- Current use of medications known to cause drug reactions that would prevent the
subject from utilizing any of the following: chloroquine, atovaquone/proguanil,
artemether/lumefantrine.

- History of severe reactions to mosquito bites.

- Acute disease and/or fever at the time of enrollment.

- Fever is defined as temperature ≥37.5°C/99.5°F for oral, axillary or tympanic
route.

- Subjects with a minor illness without fever may be enrolled at the discretion of
the investigator.

- Hepatomegaly, right upper quadrant abdominal pain or tenderness.

- Any abnormal baseline laboratory screening tests: ALT, AST, creatinine, hemoglobin,
platelet count, total WBC, out of normal range.

- Personal history of auto-immune disease.

- Administration of immunoglobulins and/or any blood products during the period starting
three months before Day 1 (for P-Fx and NP-Fx groups)/the malaria challenge (for
infectivity control subjects), or planned administration during the study period.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- History of chronic alcohol consumption and/or drug abuse.

- History of blood donation within 56 days preceding enrollment.

- Any other significant finding that in the opinion of the investigator would increase
the risk of having an adverse outcome from participating in this study.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.

- Evidence of increased cardiovascular disease risk, "moderate" or "high", according to
the National Health And Nutrition Examination Survey I (NHANES I) criteria.

Only for infectivity control subjects:

- Previous vaccination against malaria.

- History of splenectomy.

- Family history of congenital or hereditary immunodeficiency.

- Major congenital defects.

- Serious chronic illness.

- History of any neurological disorders or seizures.

- Diagnosed with malaria within the last 5 years (inclusive).
We found this trial at
1
site
Silver Spring, Maryland 20910
Principal Investigator: James E Moon
Phone: 877-379-3718
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Silver Spring, MD
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