Safety and immunogenicity of a three-component blood-stage malaria vaccine (MSP1, MSP2, RESA) against Plasmodium falciparum in Papua New Guinean children
Details
Serval ID
serval:BIB_29954EC156B6
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Safety and immunogenicity of a three-component blood-stage malaria vaccine (MSP1, MSP2, RESA) against Plasmodium falciparum in Papua New Guinean children
Journal
Vaccine
ISSN
0264-410X (Print)
Publication state
Published
Issued date
12/2003
Volume
22
Number
1
Pages
30-41
Notes
Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: Dec 8
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't --- Old month value: Dec 8
Abstract
Combination B is a malaria vaccine that comprises recombinant Plasmodium falciparum (P. falciparum) blood-stage proteins MSP1, MSP2 and RESA, formulated with the adjuvant Montanide ISA 720. A phase I-IIb double-blind randomised placebo-controlled trial was undertaken in 120 children aged 5-9 years. Subjects were randomised in four groups: (i) No sulphadoxine-pyrimethamine (SP)+vaccine, (ii) No SP+placebo, (iii) SP+vaccine, (iv) SP+placebo. 15 microg of each protein were given in the thigh, at both first and second injection (4 weeks apart). The placebo was adjuvant emulsified with saline. No serious or severe AEs occurred. Moderate AEs were seen in 3% of the vaccine and 3% of the placebo recipients after first injection and in 12 and 10% after second injection. The vaccine induced significant antibody responses to all three antigens but triggered an IFN-gamma response to MSP1 only. At Week 12, the IFN-gamma response to MSP1 was substantially higher in the vaccine group where No SP had been given. Combination B proved to be safe and immunogenic in children aged 5-9 years. Vaccine immunogenicity was neither impaired by circulating parasites nor increased after pre-treatment with SP and pre-treatment is not advisable in future trials of malaria vaccines, at least for those including blood-stage antigens.
Keywords
Animals
Antibodies, Protozoan/analysis/biosynthesis
Cell Division
Child
Child, Preschool
Cohort Studies
Cytokines/analysis/biosynthesis
Double-Blind Method
Enzyme-Linked Immunosorbent Assay
Humans
Immunization
Immunoglobulin G/analysis/biosynthesis
Interferon Type II/biosynthesis
Interleukin-10/analysis/biosynthesis
Interleukin-4/analysis/biosynthesis
Malaria Vaccines/adverse effects/*immunology
Malaria, Falciparum/epidemiology/*immunology/*prevention & control
Monocytes/immunology
Papua New Guinea/epidemiology
Plasmodium falciparum/*immunology
Tumor Necrosis Factor-alpha/analysis/biosynthesis
Pubmed
Web of science
Create date
28/01/2008 11:49
Last modification date
20/08/2019 13:09