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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

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ClinicalTrials.gov Identifier: NCT03162614
Recruitment Status : Completed
First Posted : May 22, 2017
Results First Posted : July 24, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE May 22, 2017
Results First Submitted Date  ICMJE July 1, 2019
Results First Posted Date  ICMJE July 24, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date July 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Number of Subjects With at Least One Occurrence of Plasmodium Falciparum (P. Falciparum) Parasitemia for Each Vaccination Schedule Versus Infectivity Controls [ Time Frame: Following sporozoite challenge starting 3 months after the last vaccine dose (Day 287) for up to 28 days post-challenge (Day 315). ]
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. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimination was applied for subjects not completing the entire protocol defined post challenge follow-up (Day 315 - 28 days post challenge).
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide) [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aims at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx group) versus infectivity controls.
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aims at comparing RTS,S/AS01E as double dose administered at Month 0 and Month 1 and double 1/5th dose at Month 7 (2Ped Fx group) versus infectivity controls.
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aims at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx group) versus infectivity controls.
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aims at comparing RTS,S/AS01B administered as a full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx group) versus infectivity controls.
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aims at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx group) versus infectivity controls.
Change History Complete list of historical versions of study NCT03162614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
  • Time to Onset of P. Falciparum Parasitemia After Sporozoite Challenge for Each Vaccination Schedule [ Time Frame: Following sporozoite challenge starting 3 months after the last vaccine dose (at Day 287) for up to 28 days post-challenge (at Day 315). ]
    For the analyses of time to onset of parasitemia, time at risk started on first day of challenge. Time at risk was censored on Day 315 (28 days post challenge), drop-out date, start date of antimalarial treatment or date meeting an endpoint, whichever occurs first.
  • Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations [ Time Frame: At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group ]
    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 1.9 EU/mL. The GMC calculations were performed by taking the anti-log of the mean of the log transformations (base 10). Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off (=1.0) for the purpose of GMC calculation.
  • Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations [ Time Frame: At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group ]
    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 6.2 mIU/mL.
  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3. ]
    Solicited local symptoms assessed are pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (>) 0 millimeter (mm).
  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3. ]
    Solicited general symptoms assessed are fatigue, gastrointestinal symptoms, headache and fever. Any occurrence of symptom regardless of intensity grade. Fever was defined as temperature equal or greater than (≥) 37.5 degrees Celsius (°C) for oral route, axillary or tympanic route or 38.0°C for rectal route.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination [ Time Frame: Within the 30-day period (Days 1-30), after any vaccination (across doses) ]
    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.
  • Number of Subjects With Any Unsolicited AEs After Challenge [ Time Frame: Within the 30-day (Days 1-30) period post-challenge ]
    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.
  • Number of Subjects With Any, Fatal or Related Serious Adverse Events (SAEs) After Each Vaccination [ Time Frame: Within the 30-day period (Days 1-30) after any vaccination (across doses) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Any, Fatal or Related SAEs During the Whole Study Period [ Time Frame: From Day 1 up to study conclusion (Day 377) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Any AE and SAE Leading to Withdrawal From Further Vaccination [ Time Frame: From Day 1 up to study conclusion (Day 377) ]
    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. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [ Time Frame: From Day 1 up to study conclusion (Day 377) ]
    Potential immune-mediated diseases (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.
  • Number of Subjects With Meningitis [ Time Frame: From Day 1 up to study conclusion (Day 377) ]
    Meningitis is to be reported as an adverse event of specific interest and tabulated per study group.
  • Number of Subjects With Abnormal Laboratory Values Gradings [ Time Frame: At Visit 1 Screening (Day -89 to Day 1), Day 36, Day 59, Day 204, Day 227, between Day 292 & Day 313, and Day 315 for each vaccinated subject.For Infectivity Control subjects at Visit 1b Screening (Day 231 to Day 287),between Day 292 & Day 313,and Day 315 ]
    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 (Grade 0 [GR0], Grade 1 [GR1], Grade 2 [GR2] Grade 3 [GR3]) and tabulated by group. Grading scale is taken from the [FDA guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (September 2007)].
  • Number of Subjects With Any, Fatal or Related SAE, After Challenge [ Time Frame: From day of challenge (Day 287) to the end of the challenge phase (Day 315) ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aims at comparing RTS,S/AS01E administered as double dose at Month 0 and Month 1 and double 1/5th dose at Month 7 (2PedFx group) versus immunization schedule of reference (AduFx group).
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314). ]
    The analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx) versus immunization schedule of reference (AduFx group).
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge ( at Day 314). ]
    The analysis aims at comparing RTS,S/AS01B administered as one full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx) versus immunization schedule of reference (AduFx group).
  • Number of subjects with P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: 28 days after sporozoite challenge (at Day 314 ). ]
    The analysis aims at comparing RTS,S/AS01B administered as one full dose at Month 0 and 1/5th full doses at Month 7 (Adu1Fx) versus immunization schedule of reference (AduFx group).
  • Time to onset of P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: Following sporozoite challenge three months after the last vaccine dose for up to 28 days. ]
    The analysis will be performed on each vaccination schedule versus immunization schedule of reference (AduFx group).
  • Time to onset of P. falciparum parasitemia (defined by a positive blood slide). [ Time Frame: Following sporozoite challenge three months after the last vaccine dose for up to 28 days. ]
    The analysis will be performed on each vaccination schedule versus infectivity controls.
  • Anti- Circumsporozoite (CS) repeat region antibody concentrations. [ Time Frame: At Day 0, Day 58, Day 196, Day 226, Day 286, Day 314, and Day 376 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx groups. Day 0, Day 196, Day 226, Day 286, Day 314, and Day 376 for subjects from Adu1Fx group. ]
    Concentrations expressed as Geometric Mean Concentrations (GMCs).
  • Anti-HBs IgG antibody concentrations. [ Time Frame: At Day 0, Day 58, Day 196, Day 226, Day 286, Day 314, and Day 376 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx groups. Day 0, Day 196, Day 226, Day 286, Day 314, and Day 376 for subjects from Adu1Fx group. ]
    Concentrations expressed as Geometric Mean Concentrations (GMCs).
  • Number of subjects with any solicited local and general symptoms. [ Time Frame: Within the 7-day period after each vaccination (Days 0-6). ]
    Solicited local symptoms assessed are pain, redness and swelling. Solicited general symptoms assessed are fatigue, fever, gastrointestinal symptoms and headache. Any occurrence of symptom regardless of intensity grade.
  • Number of subjects with any unsolicited adverse events (AEs) after each vaccination. [ Time Frame: Within the 30-day period after each vaccination (Days 0-29). ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
  • Number of subjects with any AE after challenge. [ Time Frame: Within the 30-day period after challenge (Days 0-29). ]
    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.
  • Number of subjects with any, fatal or related serious adverse events (SAEs) after each vaccination. [ Time Frame: Within the 30-day period after each vaccination (Days 0-29). ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of subjects with any, fatal or related SAEs. [ Time Frame: From Dose 1 (Day 0) up to study conclusion (Day 376). ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of subjects with any AE and SAE leading to withdrawal from further vaccination. [ Time Frame: From Dose 1 (Day 0) up to study conclusion (Day 376). ]
    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. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of subjects with potential Immune mediated diseases (pIMDs). [ Time Frame: From Dose 1 (Day 0) up to study conclusion (Day 376). ]
    Potential immune-mediated diseases (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.
  • Number of subjects with meningitis. [ Time Frame: From Dose 1 (Day 0) up to study conclusion (Day 376). ]
    The number of subjects reporting meningitis will be tabulated per study group.
  • Number of subjects with abnormal laboratory values. [ Time Frame: At screening, Day 35, Day 58, Day 203, Day 226, the day of first parasitemia, and Day 314 for each vaccinated subject and at screening, the day of first parasitemia and Day 314 for the infectivity control subjects. ]
    The assessed parameters will be summarised by toxicity grading scales and by group.
  • Number of subjects with any AE after challenge dose. [ Time Frame: Within the 30-day period after challenge(Day of challenge and 29 subsequent days). ]
    The analysis will be performed on the Infectivity control Group. 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.
  • Number of subjects with any, fatal or related SAE. [ Time Frame: From day of challenge (Day 286) to the end of the challenge phase (Day 314). ]
    The analysis will be performed on the Infectivity control Group. SAEs assessed will include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Various Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
Brief Summary 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.
Detailed Description

Protocol Amendment 1 incorporated: additional blood sampling for assessment of parasitemia (polymerase chain reaction [PCR] testing); clarification that blood samples for both peripheral blood mononuclear cells (PBMC) and plasma will be collected for repository storage; revision of volume of whole blood samples to be taken for parasitemia assessment; clarification that urine pregnancy tests will be conducted for all females and not just those of childbearing potential; deletion of visit at Day 1 post day of challenge; clarification that RNA sequencing and not deep sequencing will be performed in this study.

Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE
  • Biological: RTS,S/AS01E
    Subjects will receive intramuscular injection of RTS,S/AS01E.
  • Biological: RTS,S/AS01B
    Subjects will receive intramuscular injection of RTS,S/AS01B.
  • Procedure: Sporozoite-infected mosquitoes challenge.

    Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed.

    The challenge occurs approximately 90 days (three months) after the last vaccination.

    Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs.

Study Arms  ICMJE
  • Active Comparator: AduFx Group
    Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.
    Interventions:
    • Biological: RTS,S/AS01B
    • Procedure: Sporozoite-infected mosquitoes challenge.
  • Experimental: 2PedFx Group
    Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.
    Interventions:
    • Biological: RTS,S/AS01E
    • Procedure: Sporozoite-infected mosquitoes challenge.
  • Experimental: PedFx Group
    Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.
    Interventions:
    • Biological: RTS,S/AS01E
    • Procedure: Sporozoite-infected mosquitoes challenge.
  • Experimental: Adu2Fx Group
    Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.
    Interventions:
    • Biological: RTS,S/AS01B
    • Procedure: Sporozoite-infected mosquitoes challenge.
  • Active Comparator: Adu1Fx Group
    Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.
    Interventions:
    • Biological: RTS,S/AS01B
    • Procedure: Sporozoite-infected mosquitoes challenge.
  • Control Group
    Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge.
    Intervention: Procedure: Sporozoite-infected mosquitoes challenge.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2018)
154
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2017)
150
Actual Study Completion Date  ICMJE September 24, 2018
Actual Primary Completion Date July 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.

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

  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Any abnormal baseline laboratory screening tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, hemoglobin, platelet count, total white blood cells (WBC), out of normal range as defined in the protocol.
  • Evidence of increased cardiovascular disease risk, "moderate" or "high", according to the National health and nutrition examination survey I criteria.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Personal history of autoimmune disease.
  • Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03162614
Other Study ID Numbers  ICMJE 205081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE The PATH Malaria Vaccine Initiative (MVI)
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP