NCT03824236 is a Phase 2 clinical trial of RTS,S/AS01E (SB257049) in Malaria, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03824236?

NCT03824236 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03824236?

Interventions in NCT03824236: RTS,S/AS01E (SB257049).

Is NCT03824236 still recruiting?

NCT03824236 is currently completed. Last updated 14 August 2020.

Are results published for NCT03824236?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-14 · How we verify

NCT03824236

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 14 August 2020

What this trial tests

Phase 2 trial testing RTS,S/AS01E (SB257049) in Malaria in 61 participants. Completed in 26 September 2019.

Timeline

5 February 2019

Primary endpoint
30 April 2019

26 September 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	61
Start date	5 February 2019
Primary completion	30 April 2019
Estimated completion	26 September 2019
Sites	1 location across United States

Drugs / interventions tested

RTS,S/AS01E (SB257049) — full drug profile →

Conditions studied

Malaria — all drugs for Malaria →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects Reporting Plasmodium Falciparum (P. Falciparum) Parasitemia (Defined by a Positive Blood Slide) Following Sporozoite Challenge (in All Study Groups Versus Infectivity Controls) Primary · During the sporozoite challenge dose follow-up period (from Day 22 up to Day 50)

Occurrence of P. falciparum parasitemia (defined by a positive blood slide) following sporozoite challenge. Post-challenge, parasitemia was determined by microscopy of Giemsa-stained thick blood films (smear). Microscopy was performed on thick smears using a validated standard operation procedure. P. falciparum infection was defined as asexual blood stage P. falciparum parasite density greater than (\>) 0 detected by blood slide reading. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimin

Group	Value	95% CI
P-Fx Group	12
NP-Fx Group	11
Infectivity Control Group	11

Time to Onset of P. Falciparum Parasitemia (Defined by a Positive Blood Slide) Following Sporozoite Challenge Secondary · During the sporozoite challenge period starting at Day 22 (after the vaccine dose administered at Day 1), up to Day 50

For the analyses of time to onset of parasitemia (Kaplan-Meyer and log-rank), time at risk started on first day of challenge. Time at risk was censored on Day 50 (28 days post challenge), drop-out date, start date of anti-malarial treatment or date meeting an endpoint, whichever occured first. Time-at-risk was calculated as: censor date - date challenge + 1.

Group	Value	95% CI
P-Fx Group	14.6	± 1.9
NP-Fx Group	14.1	± 1.6
Infectivity Control Group	11.6	± 0.9

Anti- Circumsporozoite (CS) Repeat Region Antibody Concentrations Secondary · At Day 1, prior to challenge (Day 22), 28 days post-challenge (Day 50) and at study end (Day 190)

Anti-CS antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-linked immunosorbent assay Unit per milliliter (EU/mL). The cut-off for the assay was equal to 1.9 EU/mL. GMC calculations are performed by taking the inverse logarithm of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value of half the cut-off of the assay for the purpose of GMC calculation.

Day 1

Group	Value	95% CI
P-Fx Group	32.8	24.5 – 44.1
NP-Fx Group	7.2	3.9 – 13.4

Day 22

Group	Value	95% CI
P-Fx Group	87.3	67.0 – 113.9
NP-Fx Group	37.3	23.4 – 59.5

Day 50

Group	Value	95% CI
P-Fx Group	77.8	59.5 – 101.8
NP-Fx Group	25.7	15.3 – 43.2

Day 190

Group	Value	95% CI
P-Fx Group	49.7	37.7 – 65.7
NP-Fx Group	12.7	6.9 – 23.4

Anti-Hepatitis B (HBs) Immunoglobulin G (IgG) Antibody Concentrations Secondary · At Day 1, prior to challenge (Day 22), 28 days post-challenge (Day 50) and at study end (Day 190)

Anti-HBs IgG antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milli-International Unit per milliliter (mIU/mL). The cut-off for the assay was equal to 6.2 mIU/mL. GMC calculations are performed by taking the inverse logarithm of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value of half the cut-off of the assay for the purpose of GMC calculation.

Day 1

Group	Value	95% CI
P-Fx Group	7788	4822.8 – 12576.4
NP-Fx Group	6608.1	3147.2 – 13874.8

Day 22

Group	Value	95% CI
P-Fx Group	25344.5	16377.3 – 39221.5
NP-Fx Group	29271.3	18417.1 – 46522.4

Day 50

Group	Value	95% CI
P-Fx Group	21203.1	14058.2 – 31979.2
NP-Fx Group	19894.8	11569.4 – 34211.1

Day 190

Group	Value	95% CI
P-Fx Group	11593.9	7446.0 – 18052.6
NP-Fx Group	9092.5	4652.8 – 17768.4

Number of Subjects With Any Solicited Local Adverse Events (AEs) in the Booster Vaccination Groups Secondary · Within 7 days after vaccination (day of vaccination and 6 subsequent days) in the booster vaccination groups

Solicited local AEs assessed are erythema, pain and swelling. Any occurrence of AE regardless of intensity grade are reported. Any Erythema or any Swelling symptom = any symptom recorded with a surface diameter greater than 0 millimeter.

Erythema

Group	Value	95% CI
P-Fx Group	8
NP-Fx Group	4

Pain

Group	Value	95% CI
P-Fx Group	11
NP-Fx Group	10

Swelling

Group	Value	95% CI
P-Fx Group	4
NP-Fx Group	4

Number of Subjects With Any Solicited General AEs in the Booster Vaccination Groups Secondary · Within 7 days after vaccination (day of vaccination and 6 subsequent days) in the booster vaccination groups

Solicited general AEs assessed are fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any occurrence of symptom regardless of intensity grade and relationship to the vaccination. Fever was defined as temperature equal or greater than 37.5 °C (preferably oral route measure).

Fatigue

Group	Value	95% CI
P-Fx Group	7
NP-Fx Group	4

Gastrointestinal symptoms

Group	Value	95% CI
P-Fx Group	2
NP-Fx Group	0

Headache

Group	Value	95% CI
P-Fx Group	6
NP-Fx Group	5

Fever

Group	Value	95% CI
P-Fx Group	3
NP-Fx Group	0

Number of Subjects With Any Unsolicited AEs After Vaccination, in the Booster Vaccination Groups Secondary · Up to 21 days after booster vaccination period (day of vaccination and 20 subsequent days), after booster vaccination

An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event is any event 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.

Group	Value	95% CI
P-Fx Group	5
NP-Fx Group	1

Number of Subjects With Any Unsolicited AEs After Challenge, in All Study Groups Secondary · Within 29 days after challenge (day of challenge and 28 subsequent days)

An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.

Group	Value	95% CI
P-Fx Group	19
NP-Fx Group	19
Infectivity Control Group	12

Number of Subjects With AEs of Specific Interest (Potential Immune-mediated Diseases [pIMDs] and Meningitis), in All Study Groups Secondary · From Day 1 up to study conclusion (Day 190)

AEs of specific interest are potential immune-mediated diseases (pIMDs) and meningitis. pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Group	Value	95% CI
P-Fx Group	0
NP-Fx Group	0
Infectivity Control Group	0

Number of Subjects With Serious Adverse Events (SAEs) (Any, Fatal or Related to Investigational Vaccine) During the Whole Study Period, in All Study Groups Secondary · From Day 1 up to study conclusion (Day 190)

An SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

Any SAEs

Group	Value	95% CI
P-Fx Group	2
NP-Fx Group	0
Infectivity Control Group	0

Related SAEs

Group	Value	95% CI
P-Fx Group	0
NP-Fx Group	0
Infectivity Control Group	0

Fatal SAEs

Group	Value	95% CI
P-Fx Group	0
NP-Fx Group	0
Infectivity Control Group	0

Number of Subjects With Abnormal Laboratory Values Secondary · At screening, Day(D)1, D8, D22 (day of first parasitemia) and D50 (28 days post-challenge) for the booster vaccination groups; and at screening, D22 (day of first parasitemia) and D50 (28 days post-challenge) for the infectivity control subjects

Biochemistry (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\] and Creatinine) and hematological (Hemoglobin, Platelets, White Blood Cells \[WBC\] decrease and WBC increase) laboratory values were presented according to toxicity grading scales and tabulated by group. Grading scale adapted from FDA guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (September 2007).

ALT, Screening, Grade 0

Group	Value	95% CI
P-Fx Group	24
NP-Fx Group	23
Infectivity Control Group	11

ALT, Screening, Grade 1

Group	Value	95% CI
P-Fx Group	1
NP-Fx Group	1
Infectivity Control Group	1

ALT, Day 1, Grade 0

Group	Value	95% CI
P-Fx Group	25
NP-Fx Group	23

ALT, Day 1, Grade 1

Group	Value	95% CI
P-Fx Group	0
NP-Fx Group	1

ALT, Day 8, Grade 0

Group	Value	95% CI
P-Fx Group	24
NP-Fx Group	24

ALT, Day 8, Grade 1

Group	Value	95% CI
P-Fx Group	1
NP-Fx Group	0

ALT, Day 22, Grade 0

Group	Value	95% CI
P-Fx Group	23
NP-Fx Group	23
Infectivity Control Group	12

ALT, Day 22, Grade 1

Group	Value	95% CI
P-Fx Group	2
NP-Fx Group	1
Infectivity Control Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs were collected within the 7-day post-booster period. Unsolicited AEs were collected within the 21-day post-booster or within the 29-day post-challenge period. SAEs were collected from Day 1 up to study conclusion (Day 190).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

P-Fx Group

Serious: 2/25 (8%)

Deaths: 0/25

NP-Fx Group

Serious: 0/24 (0%)

Deaths: 0/24

Infectivity Control Group

Serious: 0/12 (0%)

Deaths: 0/12

Serious adverse events (3 terms)

Reaction	System	P-Fx Group	NP-Fx Group	Infectivity Control Group
Hypobarism	Injury, poisoning and procedural complications	—	—	—
Injury	Injury, poisoning and procedural complications	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—

Other adverse events (43 terms — click to expand)

Reaction	System	P-Fx Group	NP-Fx Group	Infectivity Control Group
Malaria	Infections and infestations	—	—	—
Injection site pain	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Injection site swelling	General disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Chills	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Feeling hot	General disorders	—	—	—
Malaise	General disorders	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—
Peripheral swelling	General disorders	—	—	—
Thirst	General disorders	—	—	—
Infection	Infections and infestations	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—
Muscle tightness	Musculoskeletal and connective tissue disorders	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Joint warmth	Musculoskeletal and connective tissue disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Post procedural discomfort	Injury, poisoning and procedural complications	—	—	—

Most-reported serious reactions: Hypobarism, Injury, Road traffic accident.

Data from ClinicalTrials.gov NCT03824236 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Immunomodulatory Nanosystems.
Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101
Virus-like particle vaccinology, from bench to bedside.
Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8
A phase IIA extension study evaluating the effect of booster vaccination with a fractional dose of RTS,S/AS01<sub>E</sub> in a controlled human malaria infection challenge.
Moon JE, Greenleaf ME, Regules JA, Debois M, et al · · 2021 · cited 13× · PMID 34593270 · DOI 10.1016/j.vaccine.2021.09.024
Identification of RTS,S/AS01 vaccine-induced humoral biomarkers predictive of protection against controlled human malaria infection.
Spreng RL, Seaton KE, Lin L, Hilliard S, et al · · 2024 · cited 3× · PMID 39377226 · DOI 10.1172/jci.insight.178801

Verify or expand the search:

Other recruiting trials for Malaria

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months · Phase 2 · recruiting
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha · Phase 1 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03824236 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 14 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03824236.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing