Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis
NCT02080026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2015-08-10
Summary
Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.
Conditions
Interventions
- BIOLOGICAL
-
CPS-immunization
Subjects will receive four 'immunizations' with bites from 15 Plasmodium infected mosquitoes during each immunization, while taking chloroquine prophylaxis.
- BIOLOGICAL
-
Controlled Human Malaria Infection
Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum, NF54 strain.
- DRUG
-
chloroquine
Registered for prophylaxis against infection with Plasmodium falciparum and the treatment of acute infections.
- DRUG
-
atovaquone/proguanil
Registered for use as an antimalarial agent for the treatment of acute infections with Plasmodium falciparum. One tablet contains: atovaquone 250 mg, proguanil(hydrochloride) 100 mg
Sponsors & Collaborators
-
Bill and Melinda Gates Foundation
collaborator OTHER -
Radboud University Medical Center
lead OTHER
Principal Investigators
-
Robert W Sauerwein, Prof. · Radboud University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2015-07-31
- Completion
- 2015-07-31
Countries
- Netherlands
Study Locations
More Related Trials
-
Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers
NCT03163121 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine
NCT01024686 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Re-exposure of Human Volunteers to a Heterologous Strain of P. Falciparum Sporozoites
NCT01660854 ·Status: COMPLETED ·Phase: NA
-
Malaria Challenge in Healthy Volunteers
NCT01500980 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults
NCT02015091 ·Status: COMPLETED ·Phase: PHASE1
-
Experimental Human Malaria Infection by PfSPZ
NCT01086917 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Protective Efficacy of Pb(PfCS@UIS4)
NCT03138096 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Comparison of Three Plasmodium Falciparum Isolates in an Experimental Human Malaria Infection
NCT01002833 ·Status: COMPLETED ·Phase: NA
-
Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune Adults
NCT01624961 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to a Malaria Vaccine (MSP1 42-C1) With or Without CPG 7909 Adjuvant
NCT00320658 ·Status: COMPLETED ·Phase: PHASE1
-
PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States
NCT02773979 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial of the PfSPZ Vaccine
NCT01001650 ·Status: COMPLETED ·Phase: PHASE1
-
Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects
NCT00675064 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study of the Safety and Immunogenicity of a Malaria Transmission-blocking Pfs25-Pfs25 Conjugate Vaccine
NCT00977899 ·Status: WITHDRAWN ·Phase: PHASE1
-
Safety and Efficacy of R0.6C Vaccine
NCT04862416 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety and Effectiveness of Two New Malaria Vaccines
NCT01003314 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Assessing Human-to-Mosquito Transmission in Volunteers Participating in Malaria Vaccine Candidate Trials in Mali
NCT02206451 ·Status: COMPLETED
-
Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen
NCT00408668 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Optimization of Controlled Human Malarial Infection by Injection of P. Falciparum Sporozoites in Non-Immune Adults
NCT01771848 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
NCT03989102 ·Status: COMPLETED ·Phase: PHASE2
-
Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)
NCT01434381 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults
NCT02996695 ·Status: COMPLETED ·Phase: PHASE1
-
Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Trial to Determine Safety and Protective Efficacy of Sanaria PfSPZ Challenge With Concurrent Pyrimethamine Treatment That Inhibits Development of Asexual B...
NCT02511054 ·Status: COMPLETED ·Phase: PHASE1
-
Malaria Vaccine for Children in Mali
NCT00740090 ·Status: COMPLETED ·Phase: PHASE1
-
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
NCT02639299 ·Status: RECRUITING