PfSPZ Vaccine Trial in Malian Children

NCT04940130 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MLSPZV5
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Malaria; Malaria,Falciparum

Keywords

PfSPZ Vaccine; Malaria; Plasmodium falciparum

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Possibly, Probably, or Definitely Related Serious Adverse Events (SAEs)

  Proportion of vaccinees compared to controls experiencing related SAEs from V1 to 26 weeks after V3

  From day of first vaccination until 26 weeks after 3rd vaccination (study day 1 to day 211)

Study Arms (2)

Arm 1 (PfSPZ Vaccine)

EXPERIMENTAL

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

Arm 2 (normal saline)

PLACEBO COMPARATOR

134 children ages 6 - 10 will receive normal saline via DVI at 1, 8, and 29 days

Other: Normal Saline

Interventions

Sanaria® PfSPZ Vaccine BIOLOGICAL

non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).

Arm 1 (PfSPZ Vaccine)

Normal Saline OTHER

placebo control- saline

Arm 2 (normal saline)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanaria Inc.: lead
• Malaria Research and Training Center, Bamako, Mali: collaborator
• University of the Sciences, Techniques and Technologies of Bamako: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Patrick Duffy
• Organization: Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health

patrick.duffy@nih.gov

301.761.5089

Study Officials

• Patrick Duffy, MD

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

• Issaka Sagara, MD MSPH PhD

  Malaria Research and Training Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, placebo controlled, with concurrent arms

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 25, 2021
• Study Start: April 1, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)