Efficacy, Safety and Immunogenicity Study of GlaxoSmithKl... | NCT01857869

NCT01857869

Status Module

Sponsor/Collaborators Module

Name	Class
Walter Reed Army Institute of Research (WRAIR)	FED
The PATH Malaria Vaccine Initiative (MVI)	OTHER

Oversight Module

No data available

No data is available for this block.

Description Module

Detailed Description

This protocol posting has been amended to reflect changes in Amendment 1 of the Protocol (20 April 2014).

Rationale for Protocol Amendment 1:

• In order to assess whether protection is maintained over time, and assess boostability, the protocol has been amended to incorporate another sporozoite challenge, after a single boost of 1/5th standard dose of RTS,S/AS01B, or no boost.

Study design:

Dependent upon enrolment date during the screening period, the study duration will be approximately 19 months for each vaccinated subject in the delayed fractional dose group, 14 months for each vaccinated subject in the 0, 1, 2-month group, 7 months for each infectivity control subject in the challenge phase and 6 months for each infectivity control subject in the rechallenge phase.
Vaccination schedules:
- 0, 1, 7-month followed by sporozoite challenge 21 days (3 weeks) after the third vaccination, with subsequent boosting/no boosting at Booster Phase Study Day 0 followed by sporozoite rechallenge 3 weeks post boost/no boost.
- 0, 1, 2-month followed by sporozoite challenge 21 days (3 weeks) after the third vaccination, with subsequent boosting/no boosting at Booster Phase Study Day 0 followed by sporozoite rechallenge 3 weeks post boost/no boost.
Safety and immunogenicity will be evaluated during the study up to 3 months after rechallenge (Booster Phase Study Day 105).
Treatment allocation:
- Non-randomized for primary phase; subjects will be enrolled to different study groups in a consecutive manner, to ensure the day of sporozoite challenge (conducted over two days) is the same for all.
- For the booster and rechallenge phase, subjects unprotected during the first challenge will receive a 1/5th RTS,S/AS01B booster dose while subjects from each group who were protected in the first challenge will be randomized to receive a 1/5th RTS,S/AS01B booster dose or no booster dose.

This protocol posting has been amended to reflect changes in Amendment 2 of the Protocol (08 January 2015) Rationale for Protocol Amendment 2: In order to have sufficient blood samples for future assay development or testing, evaluation of Hepatitis B (HBs) cellular-mediated immunogenicity (CMI) was de-prioritised from a secondary outcome measure to a tertiary secondary outcome measure and will only be conducted if sufficient cells are available from the thawn cryotube(s) that will be used for circumsporozoite protein (CS) testing.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GSK257049-0,1,7M Group	Experimental	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by another dose of GSK257049 vaccine.	Biological: GSK257049 Dosage 1
GSK257049-0,1,2M Group	Experimental	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months).	Biological: GSK257049 Dosage 2
Infectivity Control Group	Experimental	Volunteers who did not receive any immunization but underwent sporozoite challenge	Procedure: Sporozoite-infected mosquitoes challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK257049 Dosage 1	Biological	RTS,S/AS01B administered as 0.5 mL dose at 0 and 1 months and 0.1 mL dose at 7 months for 0,1,7 M Group (delayed fractional dose group). In subjects unprotected in the first challenge, to receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. In subjects protected in the first challenge, randomization to receive or not receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Plasmodium Falciparum Parasitemia Defined by a Positive Blood Slide, Following Sporozoite Challenge	The definition of malaria for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.	28 days post-challenge (Study Day 245)

Secondary Outcomes

Measure	Description	Time Frame
Time to Onset of P. Falciparum Parasitemia Infection Defined by a Positive Blood Slide, Following Sporozoite Challenge	The time to onset was expressed in days. The definition of malaria infection for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.	Up to 28 days post-challenge (Study Day 245)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion criteria for enrolment to the primary phase:

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or non-pregnant female 18 to 50 years of age at the time of first vaccination.
Written informed consent obtained from the subject before screening procedures.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Available to participate for the duration of the study (approximately 15 months per vaccinated subject in the delayed fractional dose group, approximately 10 months per vaccinated subject in the 0, 1, 2-month schedule and approximately 7 months per subject in the infectivity control group).
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 FDA-approved contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate FDA-approved contraception during the entire treatment period and for 2 months after completion of the vaccination series and/or malaria challenge.

Inclusion criteria for enrolment to the booster phase:

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 before screening procedures.
Subjects vaccinated in the primary phase of the study (not applicable to new infectivity controls), having undergone sporozoite challenge during the primary phase of the study.
Available to participate for the duration of the booster phase of the study (approximately 3 months).
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 booster phase of the study, if the subject:
- has practiced adequate FDA-approved contraception for 30 days prior to day of booster vaccination, and
- has a negative pregnancy test on the day of booster vaccination, and
- has agreed to continue adequate FDA-approved contraception during the entire treatment period and for 2 months after completion of the booster vaccination and/or malaria rechallenge.

Exclusion Criteria:

For enrolment to the primary & booster phase:

Any confirmed or suspected immunosuppressive or immunodeficient condition, including immunodeficiency virus (HIV) infection.
Acute disease and/or fever at the time of enrolment to booster phase.
- Acute disease is defined as the presence of a moderate or severe illness with or without fever. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Fever is defined as temperature ≥ 38.0°C (100.4°F) on oral, axillary or tympanic setting. The preferred route for recording temperature in this study will be oral.
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.

Note: NHANES I criteria will be applied for all subjects including subjects aged 18-35 years old.

An abnormal baseline screening electrocardiogram (EKG), defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm excluding isolated premature atrial contractions; right or left bundle branch block; or advanced A-V heart block.
Female who intends to become pregnant during the study or planning to discontinue contraceptive measures.

For enrolment to the primary phase:

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol within 7 days of the first dose of vaccines.
Prior receipt of an investigational malaria vaccine.
Chronic use of antibiotics with antimalarial effects.
History of malaria chemoprophylaxis within 60 days prior to vaccination.
Any history of malaria.
Planned travel to malaria endemic areas during the study period.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including latex.
History of allergic disease or reactions 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.
Any history of anaphylaxis in reaction to any previous vaccination.
History of severe reactions to mosquito bites.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to first vaccine dose. For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 20 mg/day. Inhaled and topical steroids are allowed.
Family history of congenital or hereditary immunodeficiency.
History of splenectomy.
Major congenital defects or serious chronic illness.
History of any neurological disorders or seizures, except for a single episode of simple febrile seizure in childhood.
Any abnormal baseline laboratory screening tests: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), creatinine, hemoglobin, platelet count, total white blood cell count, out of normal range as defined in the protocol.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Personal history of autoimmune disease.
Seropositive for hepatitis B surface antigen or Hepatitis C virus.
Pregnant or lactating female.
Suspected or known current alcohol abuse.
Chronic or active intravenous drug use.
History of blood donation within 56 days preceding enrolment.
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.

For enrolment to the booster phase:

Planned use of any investigational or non-registered product other than the study vaccine during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol within 7 days of booster dose of study vaccine.
Planned administration of immunoglobulins and/or any blood products during the study period.
An abnormal baseline laboratory screening test, graded 2 or more as defined in the protocol.
Any abnormal baseline laboratory screening tests out of normal range as defined in the protocol and of clinical concern according to the Principal Investigator.
Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in the booster phase of the study.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Silver Spring	Maryland	20910	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27296848	Background	Regules JA, Cicatelli SB, Bennett JW, Paolino KM, Twomey PS, Moon JE, Kathcart AK, Hauns KD, Komisar JL, Qabar AN, Davidson SA, Dutta S, Griffith ME, Magee CD, Wojnarski M, Livezey JR, Kress AT, Waterman PE, Jongert E, Wille-Reece U, Volkmuth W, Emerling D, Robinson WH, Lievens M, Morelle D, Lee CK, Yassin-Rajkumar B, Weltzin R, Cohen J, Paris RM, Waters NC, Birkett AJ, Kaslow DC, Ballou WR, Ockenhouse CF, Vekemans J. Fractional Third and Fourth Dose of RTS,S/AS01 Malaria Candidate Vaccine: A Phase 2a Controlled Human Malaria Parasite Infection and Immunogenicity Study. J Infect Dis. 2016 Sep 1;214(5):762-71. doi: 10.1093/infdis/jiw237. Epub 2016 Jun 13.
39377226

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
117014	Dataset Specification	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (controlled human malaria infection [CHMI]).
FG001	GSK257049-0,1,2M Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG0030 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

FG0040 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

FG0050 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

FG0060 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

FG0070 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

FG0080 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

FG0090 subjectsOnly GSK257049-0,1,7M,GSK257049-0,1,2M and Infectivity Control Groups were included in Primary phase

The number of participants included in the Booster/Rechallenge Phase (0,1,7 M P-NoBo Group; 0,1,7 M P-Bo Group; 0,1,7 NP-Bo Group; 0,1,2 M P-NoBo Group; 0,1,2 M P-Bo Group; 0,1,2 M NP-Bo Group; and Control Group Follow-up) were also in Primary/Challenge Phase (GSK257049-0,1,7M Group; GSK257049-0,1,2M Group; and Infectivity Control Group).

Arm/Group Information

ID	Title	Description
BG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
BG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
BG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).
BG003	GSK257049-0,1,7M P-NoBo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
BG004	GSK257049-0,1,7M P-Bo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
BG005	GSK257049-0,1,7M NP-Bo Group	Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
BG006	GSK257049-0,1,2M P-NoBo Group	Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallange.
BG007	GSK257049-0,1,2M P-Bo Group	Subjects from GSK257049-0,1,2M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
BG008	GSK257049-0,1,2M NP-Bo Group	Subjects from GSK257049-0,1,2M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
BG009	Control Group Follow-up	Subjects from Control Group in Primary Phase who remained uninfected with P. falciparum malaria and enrolled as infectivity controls for Follow-up Phase to undergo sporozoite rechallange.
BG010	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

This baseline measure refers to the Primary/challenge phase population.

Mean

Standard Deviation

Years

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00117 ParticipantsBG00212 ParticipantsBG003

Sex: Female, Male

This baseline measure refers to the Primary/challenge phase population.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00117 ParticipantsBG002

Race/Ethnicity, Customized

This baseline measure refers to the Primary/challenge phase population.

Count of Participants

Participants

Title	Denominators	Categories
Geographic ancestry	ParticipantsBG00034 ParticipantsBG00117 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Plasmodium Falciparum Parasitemia Defined by a Positive Blood Slide, Following Sporozoite Challenge

The definition of malaria for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.

The analysis was based on the According-to-Protocol (ATP) population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.

Posted

Count of Participants

Participants

28 days post-challenge (Study Day 245)

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Units	Counts
Participants	OG00030 OG00116 OG00212

Title

Denominators

Categories

Title	Measurements
	OG0004 OG0016 OG00212

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Vaccine efficacy (VE) was defined as 100*(1-Relative Risk [RR]).	Mantel Haenszel		<0.0001	Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.	1-Relative Risk	86.7			2-Sided	95	66.8	94.6					Other
OG001

Secondary

Time to Onset of P. Falciparum Parasitemia Infection Defined by a Positive Blood Slide, Following Sporozoite Challenge

The time to onset was expressed in days. The definition of malaria infection for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.

The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI. This analysis included those subjects with a positive blood slide.

Posted

Mean

Standard Deviation

Days

Up to 28 days post-challenge (Study Day 245)

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Secondary

Number of Subjects With Plasmodium Falciparum Parasitemia Defined by a Positive Blood Slide, Following Sporozoite Rechallenge

The definition of malaria infection for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.

The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge Phase, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge.

Posted

Count of Participants

Participants

Up to 28 days post rechallenge (Booster Phase Day 49)

ID	Title	Description
OG000	GSK257049-0,1,7M P-NoBo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
OG001	GSK257049-0,1,7M P-Bo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
OG002	GSK257049-0,1,7M NP-Bo Group	Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.

Secondary

Time to Onset of P. Falciparum Parasitemia Infection Defined by a Positive Blood Slide, Following Sporozoite Rechallenge

Posted

Mean

Standard Deviation

Days

Up to 28 days post rechallenge (Booster Phase Day 49)

ID	Title	Description
OG000	GSK257049-0,1,7M P-NoBo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
OG001	GSK257049-0,1,7M P-Bo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
OG002	GSK257049-0,1,2M P-NoBo Group

Secondary

Anti-circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations

Anti-CS antibody concentrations were determined by Enzyme Linked Immunosorbent Assay (ELISA) and expressed as EU/mL.

The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

7 days before vaccination (D-7), post-dose 1 at Day 28, post-dose 2 at Days 42, 56, 98, 196, at DoC Primary Phase (PP) (Day of CHMI = Day 217), at DoC PP (Day 217) + 7, 14, 28, 42, 56, 70, 84, 159 days (Days 224, 231, 245, 259, 273, 287, 301, 376).

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Secondary

Anti-CS Repeat Region Antibody Concentrations for the Rechallenge Phase

Anti-CS antibody concentrations were determined by Enzyme Linked Immunosorbent Assay (ELISA) and expressed as EU/mL.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Day 0 of rechallenge (pre-booster dose) and at DoC PP (Day 217 = Day of rechallenge)

ID	Title	Description
OG000	GSK257049-0,1,7M P-NoBo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
OG001	GSK257049-0,1,7M P-Bo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
OG002	GSK257049-0,1,7M NP-Bo Group	Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.

Secondary

Frequency of CS Repeat and T-cell Epitope (RT)-Specific Cluster of Differentiation 4 (CD4) T-cells

Frequency of Cluster of Differentiation 4 (CD4) polypositives T-cells with at least 2 cytokines/activation markers between CD40-Ligand (CD40-L), interferon gamma (INF-g), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-a) was assessed for peripheral blood mononuclear cells (PBMC) with intracellular cytokine staining (ICS).

Posted

Mean

Standard Deviation

CD4+ T-cells/million CD4 T-cells

7 days before vaccination (D-7), post-dose 1 at Day 14, post-dose 2 at Day 42, at DoC PP (Day of CHMI = Day 217), at DoC PP (Day 217) + 7, 28, 84, 159 days (Days 224, 245, 301, 376).

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002

Secondary

Frequency of CS Repeat and T-cell Epitope (RT)-Specific CD8 T-cells

Frequency of CD8 polypositives T-cells with at least 2 cytokines/activation markers between CD40-L, INF-g, IL-2 and TNF-a was assessed for PBMC with ICS.

Posted

Mean

Standard Deviation

CD8+ T-cells/million CD8 T-cells

7 days before vaccination (D-7), post-dose 1 at Day 14, post-dose 2 at Day 42, at DoC PP (Day of CHMI = Day 217), at DoC PP (Day 217) + 7, 28, 84, 159 days (Days 224, 245, 301, 376).

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Secondary

Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)

Anti-HBs antibody concentrations were determined by Chemiluminometric Immunoassay (CLIA) and expressed as miliinternation units per mililier (mIU/mL).

The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

7 days before vaccination (D-7), post-dose 1 at Day 28, post-dose 2 at Days 42, 56, 98, 196 after first dose, at DoC PP (Day of CHMI = Day 217), at DoC PP (Day 217)+ 7, 14, 28, 42, 56, 70, 84, 159 days (Days 224, 231, 245, 259, 273, 287, 301, 376).

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Secondary

Anti-HBs Antibody Concentrations for Rechallenge Phase

Anti-HBs antibody concentrations were determined by Chemiluminometric Immunoassay (CLIA).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At Day 0 of rechallenge (pre-booster dose) and at DoC PP (Day 217 = Day of rechallenge)

ID	Title	Description
OG000	GSK257049-0,1,7M P-NoBo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
OG001	GSK257049-0,1,7M P-Bo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
OG002	GSK257049-0,1,7M NP-Bo Group	Subjects from GSK257049-0,1,7M Group who were not protected (NP) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.

Secondary

Anti-CS Repeat Region Immunoglobulin G (IgG) Avidity Index for the Challenge Phase

The avidity index percentage was calculated by anti-CS repeat region concentration under chaotropic reagent/anti-CS repeat region concentration without chaotropic reagent. The median and inter-quartile (Q1 and Q3) range was reported at the prespecified time-points.

The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.

Posted

Median

Inter-Quartile Range

Avidity index

Post-dose 1 at Day 28, post-dose 2 at Days 56, and 196, DoC PP (DoC = the day of CHMI, Day 217), DoC PP (Day 217) + 84 days (Day 301) and DoC PP (Day 217) +159 days (Day 376)

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group

Secondary

Anti-CS Repeat Region IgG Avidity Index for the Rechallenge Phase

The avidity index percentage was calculated by anti-CS repeat region titer under chaotropic reagent/anti-CS repeat region titer without chaotropic reagent. The median and inter-quartile (Q1 and Q3) range was reported at the prespecified time-points.

The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge. Results were not reported for the Control Group Follow-up, since subjects from this group did not receive any immunization.

Posted

Median

Inter-Quartile Range

Avidity index

Pre-booster dose (Booster phase Day 0) and at DoC Booster/rechallenge phase (Day of Controlled Human Malaria Infection - Day 21)

ID	Title	Description
OG000	GSK257049-0,1,7M P-NoBo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received no booster dose (NoBo) of GSK257049 vaccine and underwent sporozoite rechallenge.
OG001	GSK257049-0,1,7M P-Bo Group	Subjects from GSK257049-0,1,7M Group who were protected (P) during first CHMI and who received a booster fractional low-formulated (Bo) of GSK257049 vaccine and underwent sporozoite rechallange.
OG002

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The analysis was based on the Intention-to-Treat (ITT) population, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. Results were not reported for the Infectivity Control Group, since subjects from this group did not receive any immunization.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting and/or abdominal pain), headache and fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. Results were not reported for the Infectivity Control Group, since subjects from this group did not receive any immunization.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The analysis was based on the ITT population for the rechallenge, which included subjects from the ITT population consenting to the rechallenge. For the purpose of the analysis, subjects who received a low fractional formulation booster dose of GSK257049 vaccine have been pooled into a single group and results were tabulated accordingly.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post- booster vaccination period

ID	Title	Description
OG000	Boosted Group	Pooled group comprising subjects from the GSK257049-0,1,7M P-Bo Group; GSK257049-0,1,7M NP-Bo Group; GSK257049-0,1,2M P-Bo Group and GSK257049-0,1,2M NP-Bo Group (protected and not protected subjects from the Primary Phase groups, that received a low fractional formulation booster dose of GSK257049 vaccine).

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Posted

Count of Participants

Participants

Within the 7-day (Days 0-6) post- booster vaccination period

ID	Title	Description
OG000	Boosted Group	Pooled group comprising subjects from the GSK257049-0,1,7M P-Bo Group; GSK257049-0,1,7M NP-Bo Group; GSK257049-0,1,2M P-Bo Group and GSK257049-0,1,2M NP-Bo Group (protected and not protected subjects from the Primary Phase groups, that received a low fractional formulation booster dose of GSK257049 vaccine).

Units	Counts
Participants

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented. Results were not reported for the Infectivity Control Group, since subjects from this group did not receive any immunization.

Posted

Count of Participants

Participants

Within 30-days (Days 0-29) post-primary vaccination

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

Posted

Count of Participants

Participants

Within 30-days (Days 0-29) post- booster vaccination

ID	Title	Description
OG000	Boosted Group	Pooled group comprising subjects from the GSK257049-0,1,7M P-Bo Group; GSK257049-0,1,7M NP-Bo Group; GSK257049-0,1,2M P-Bo Group and GSK257049-0,1,2M NP-Bo Group (protected and not protected subjects from the Primary Phase groups, that received a low fractional formulation booster dose of GSK257049 vaccine).

Units	Counts
Participants

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented and who had post-first CHMI available results.

Posted

Count of Participants

Participants

Within 30-days (Days 0-29) post-first CHMI

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

The analysis was based on the ITT population for the rechallenge, which included subjects from the ITT population consenting to the rechallenge.

Posted

Count of Participants

Participants

Within 30-days (Days 0-29) post- second CHMI

ID	Title	Description
OG000	Non Boosted Group	Pooled group comprising subjects from the GSK257049-0,1,7M P-NoBo and GSK257049-0,1,2M P-NoBo Group (protected subjects from the Primary Phase groups, that did not receive a booster dose of GSK257049 vaccine.
OG001	Boosted Group	Pooled group comprising subjects from the GSK257049-0,1,7M P-Bo Group; GSK257049-0,1,7M NP-Bo Group; GSK257049-0,1,2M P-Bo Group and GSK257049-0,1,2M NP-Bo Group (protected and not protected subjects from the Primary Phase groups, that received a low fractional formulation booster dose of GSK257049 vaccine).

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

From study start to end of Primary Phase (Study Day 245)

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the entire study period (Up to Day 105 of Booster Phase)

ID	Title	Description
OG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).
OG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).
OG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	GSK257049-0,1,7M Group	Subjects receiving 2 doses of GSK257049 vaccine given at 0 and 1 months and followed 6 months later (At Month 7) by a fractional dose of GSK257049 vaccine and underwent sporozoite challenge (CHMI).	34	1	34	34	34
EG001	GSK257049-0,1,2M Group	Subjects receiving 3 doses of GSK257049 vaccine given one month apart (0,1 and 2 months) and underwent sporozoite challenge (CHMI).	17	0	17	17	17
EG002	Infectivity Control Group	Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).	12	0	12	0	12

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 events1 affected34 at risk EG0010 events0 affected17 at risk EG0020 events0 affected12 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0013 events3 affected17 at risk EG0020 affected12 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0005 events4 affected34 at risk EG0015 events4 affected17 at risk EG0020 affected12 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected17 at risk EG0020 affected12 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG00050 events27 affected34 at risk EG00123 events13 affected17 at risk EG0020 affected12 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG00039 events20 affected34 at risk EG00119 events10 affected17 at risk EG0020 affected12 at risk
Feeling hot	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00015 events8 affected34 at risk EG00112 events8 affected17 at risk EG0020 affected12 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00044 events21 affected34 at risk EG00130 events12 affected17 at risk EG0020 affected12 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00012 events10 affected34 at risk EG0016 events4 affected17 at risk EG0020 affected12 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG00088 events32 affected34 at risk EG00143 events16 affected17 at risk EG0020 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected34 at risk EG0010 events0 affected17 at risk EG0020 affected12 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0009 events8 affected34 at risk EG0014 events4 affected17 at risk EG0020 affected12 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk
Swelling	General disorders	MedDRA 18.0	Systematic Assessment	EG00039 events23 affected34 at risk EG0018 events6 affected17 at risk EG0020 affected12 at risk
Tooth abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0011 events1 affected17 at risk EG0020 affected12 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events1 affected17 at risk EG0020 affected12 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected34 at risk EG0017 events7 affected17 at risk EG0020 affected12 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected34 at risk EG0012 events2 affected17 at risk EG0020 affected12 at risk

ID	Term
D008288	Malaria

ID	Term
C526041	RTS,S-AS01B vaccine

Volunteers who did not receive any immunization but underwent sporozoite challenge (CHMI).

Units	Counts
Participants	OG00034 OG00117

Units	Counts
Participants	OG00034 OG00117

Units	Counts
Participants	OG00034 OG00117 OG00212

Units	Counts
Participants	OG00034 OG00117 OG00212

OG00116.3(8.0 to 33.2)

OG00164.4(34.1 to 121.8)

OG00157.9(30.7 to 109.4)

OG001100.1(63.5 to 157.8)

OG0020.4(0.2 to 0.8)

OG00191.7(57.5 to 146.2)

OG0020.4(0.2 to 0.8)

OG00179.4(48.5 to 130.0)

OG0020.4(0.2 to 0.8)

OG00175.7(45.8 to 125.2)

OG0020.5(0.3 to 1.0)

OG00173.6(45.3 to 119.7)

OG0020.6(0.3 to 1.1)

OG00163.2(34.9 to 114.3)

OG0020.5(0.3 to 1.0)

OG00159.2(35.1 to 99.8)

OG0020.5(0.3 to 1.0)

OG00155.3(34.4 to 88.9)

OG0020.5(0.3 to 1.0)

OG00134.6(20.9 to 57.0)

OG0020.5(0.3 to 1.0)

OG001242.53± 262.97

OG001866.87± 779.25

OG001555.86± 487.16

OG001539.40± 416.68

OG001472.63± 287.64

OG002162.22± 275.51

OG001472.63± 287.64

OG001307.87± 231.91

OG0017318.2(643.5 to 83221.5)

(14549.0 to 84279.4)

OG00127205.5(5504.0 to 134473.9)

OG00120625.8(3809.7 to 111668.5)

(20777.5 to 54709.5)

OG00131798.7(8809.6 to 114779.3)

OG00227.9(6.6 to 118.1)

(18090.1 to 49428.5)

OG00128989.2(7097.6 to 118403.1)

OG00232.5(7.3 to 145.1)

(20513.7 to 61092.8)

OG00124952.2(6402.7 to 97242.0)

OG00225.7(6.4 to 103.0)

(14413.9 to 45303.2)

OG00125944.1(7496.3 to 89790.9)

OG00227.5(6.5 to 116.4)

(13130.3 to 42986.3)

OG00120000.3(5110.6 to 78271.6)

OG00232.8(7.3 to 146.6)

(14012.2 to 47937.4)

OG00123199.5(5472.8 to 98343.4)

OG00234.6(7.7 to 155.2)

(12431.5 to 45268.1)

OG00123313.8(6098.3 to 89128.6)

OG00231.9(7.3 to 139.8)

(10713.8 to 34247.0)

OG00119631.5(6184.8 to 62313.2)

OG00226.3(6.5 to 106.5)

OG00113495.2(3956.7 to 46028.2)

OG00226.2(6.5 to 106.0)

OG00131.10(19.85 to 33.50)

OG00129.00(22.40 to 34.05)

OG00128.30(18.70 to 31.50)

OG00232.10(20.50 to 43.70)

OG00128.90(19.60 to 32.70)

OG00232.05(21.90 to 42.20)

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases