PfSPZ Vaccine Trial in Malian Children
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|ClinicalTrials.gov Identifier: NCT04940130|
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : April 12, 2022
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In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of PfSPZ Vaccine (or placebo) at 1, 8, and 29-days using direct venous inoculation (DVI).
The study is composed of a single cohort with two arms (categorized by placebo control/experimental groups) designed to assess the safety, immunogenicity and protective efficacy of PfSPZ Vaccine.
All subjects will receive artemether-lumefantrine (AL) approximately 1- 2 weeks before the first dose of PfSPZ Vaccine or normal saline for clearance of Pf parasitemia. Vaccinated participants and non-immunized controls will be followed for safety and monitored for development of parasitemia through the natural malaria transmission season to estimate vaccine efficacy (VE).
|Condition or disease||Intervention/treatment||Phase|
|Malaria Malaria,Falciparum||Biological: Sanaria® PfSPZ Vaccine Other: Normal Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||268 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, placebo controlled, with concurrent arms|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Trial of Safety, Immunogenicity, and Efficacy Against Plasmodium Falciparum Malaria of PfSPZ Vaccine in Children in Mali|
|Actual Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Arm 1 (PfSPZ Vaccine)
134 children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10^5 PfSPZ) via DVI at 1, 8, and 29 days
Biological: Sanaria® PfSPZ Vaccine
non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
Placebo Comparator: Arm 2 (normal saline)
134 children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days
Other: Normal Saline
placebo control- saline
- Safety of PfSPZ Vaccine in children with respect to the occurrence of possibly, probably, or definitely related serious adverse events (SAEs) [ Time Frame: vaccination 1 to 26 weeks after vaccination 3 ]Proportion of vaccinees compared to controls experiencing related SAEs from V1 to 26 weeks after V3
- Vaccine efficacy against first episode of Pf malaria with symptoms by time-to-event analysis [ Time Frame: 2 weeks after vaccination 3 to 26 weeks after vaccination 3 ]VE computed as one minus the estimated hazard ratio (HR) for first episode of Pf malaria with symptoms from 2 weeks after V3 to 26 weeks after V3 in the modified ITT (mITT) population.
- Safety and tolerability in children [ Time Frame: Vaccination 1 to 14 days after Vaccination 3 ]
The differences in proportions of vaccinees compared to controls experiencing unsolicited AEs from the time of V1 to 14 days after V3 (or last immunization).
- The differences in proportions of vaccinees compared to controls experiencing laboratory abnormalities from time of V1 to 14 days after V3.
- The differences in proportions of vaccinees compared to controls experiencing solicited AEs during the 7 days following each immunization.
- Vaccine Efficacy (VE) by Hazard Ratio (HR) [ Time Frame: 2 to 26 weeks after Vaccination 3 ]VE computed as one minus the estimated HR for first episode of Pf malaria detected by thick blood smear (TBS), from 2 weeks after V3 to 26 weeks after V3 in the mITT population.
- Antibody responses to Pf circumsporozoite protein (CSP) [ Time Frame: 2 to 26 weeks after Vaccination 3 ]Antibody levels to PfCSP by standardized ELISA comparing protected and unprotected vaccinees and controls.
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|Ages Eligible for Study:||6 Years to 10 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Parent(s) or guardian(s) willing and able to provide consent prior to initiation of any study procedures
- Stated willingness of parent(s) or guardian(s) to comply with all study procedures and availability for the duration of the study
- Malaria comprehension exam completed by parent(s) or guardian(s) and passed with a score of ≥80% or per investigator's discretion
- Healthy children 6-10 years of age at enrollment (inclusive)
- Parent(s) or guardian(s) are able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Willing to have blood samples stored for future research
- Medical, behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant's parent and/or legal guardian to understand and comply with the study protocol
- Menstruating females (in order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group)
- Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratory-defined limits of normal and ≥ Grade 2 (subjects may be included at the investigator's discretion for 'not clinically significant' abnormal values)
- Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (subjects may be included at the investigator's discretion for 'not clinically significant' abnormal values)
- Infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Sickle cell disease by history
- Taking or planning to take seasonal malaria chemoprophylaxis
- Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc
History of receipt of the following:
- Investigational malaria vaccine in the last 2 years
- Immunoglobulins and/or blood products within 6 months of enrollment
- Investigational product within 3 months of enrollment
- Chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg/day or equivalent) or immunosuppressive drugs within 30 days of enrollment
- Live vaccine within 30 days of enrollment
- Killed vaccine within 14 days of enrollment or planned receipt of a killed vaccine within 14 days of scheduled vaccination
Known medical problems:
- Pre-existing autoimmune or antibody-mediated diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia)
- Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
- Immunodeficiency disorder
- Asplenia or functional asplenia
- Deep venous thrombosis or thromboembolic event
- Seizures (exception is simple febrile seizures during childhood)
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04940130
|Contact: Issaka Sagara, MD MSPH PhDemail@example.com|
|Malaria Research and Training Center||Recruiting|
|Contact: Issaka Sagara|
|Principal Investigator:||Patrick Duffy, MD||National Institute of Allergy and Infectious Diseases (NIAID)|
|Principal Investigator:||Issaka Sagara, MD MSPH PhD||Malaria Research and Training Center|
|Responsible Party:||Sanaria Inc.|
|Other Study ID Numbers:||
|First Posted:||June 25, 2021 Key Record Dates|
|Last Update Posted:||April 12, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Vector Borne Diseases