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- Hu, Jinhong, et al.
(författare)
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Safety and immunogenicity of a malaria vaccine, Plasmodium falciparum AMA-1/MSP-1 chimeric protein formulated in montanide ISA 720 in healthy adults
- 2008
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Ingår i: PLOS ONE. - : PLOS. - 1932-6203. ; 3:4
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The P. falciparum chimeric protein 2.9 (PfCP-2.9) consisting of the sequences of MSP1-19 and AMA-1 (III) is a malaria vaccine candidate that was found to induce inhibitory antibodies in rabbits and monkeys. This was a phase I randomized, single-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of the PfCP-2.9 formulated with a novel adjuvant Montanide ISA720. Fifty-two subjects were randomly assigned to 4 dose groups of 10 participants, each receiving the test vaccine of 20, 50, 100, or 200 microg respectively, and 1 placebo group of 12 participants receiving the adjuvant only.METHODS AND FINDINGS: The vaccine formulation was shown to be safe and well-tolerated, and none of the participants withdrew. The total incidence of local adverse events (AEs) was 75%, distributed among 58% of the placebo group and 80% of those vaccinated. Among the vaccinated, 65% had events that were mild and 15% experienced moderate AEs. Almost all systemic adverse reactions observed in this study were graded as mild and required no therapy. The participants receiving the test vaccine developed detectable antibody responses which were boosted by the repeated vaccinations. Sixty percent of the vaccinated participants had high ELISA titers (>1:10,000) of antigen-specific antibodies which could also recognize native parasite proteins in an immunofluorescence assay (IFA).CONCLUSION: This study is the first clinical trial for this candidate and builds on previous investigations supporting PfCP-2.9/ISA720 as a promising blood-stage malaria vaccine. Results demonstrate safety, tolerability (particularly at the lower doses tested) and immunogenicity of the formulation. Further clinical development is ongoing to explore optimizing the dose and schedule of the formulation to decrease reactogenicity without compromising immunogenicity.TRIAL REGISTRATION: Chinese State Food and Drug Administration (SFDA) 2002SL0046; Controlled-Trials.com ISRCTN66850051 [66850051].
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| 2. |
- Peng, Yongmei, et al.
(författare)
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Fatty acid composition of diet, cord blood and breast milk in Chinese mothers with different dietary habits.
- 2009
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Ingår i: Prostaglandins, leukotrienes, and essential fatty acids. - : Elsevier BV. - 1532-2823 .- 0952-3278. ; 81:5-6, s. 325-30
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Tidskriftsartikel (refereegranskat)abstract
- The influence of two different dietary patterns on maternal fatty acid (FA) intake on the composition of umbilical cord blood plasma phospholipids and transitional breast milk was investigated. A 7-day dietary record was completed in the last trimester of pregnancy by women living in an inland and a coastal area of south-eastern China. The FA composition in maternal diet was calculated using the 2002 Chinese food composition database. Cord blood and transitional breast milk samples were collected and their FA composition was analyzed by capillary gas-liquid chromatography. Mothers in the coastal area showed higher intake of long-chain polyunsaturated FA (LCPUFA) including docosahexaenoic acid (DHA, 22:6omega) and eicosapentaenoic acid (EPA,20:5omega3) but lower linoleic acid (LA, 18:2omega6) and alpha-linolenic acid (ALA, 18:3omega3) than the mothers in the inland area. The intake of arachidonic acid (AA, 20:4omega6) did not differ between the two areas. LA, ALA, AA and DHA in breast milk of day 5 reflected the maternal diet except that the EPA content in breast milk at day 5 was similar for the areas. LA, ALA and AA were lower and EPA higher in umbilical cord plasma phospholipids in infants from the costal compared to the inland area. There were significant differences in maternal intakes of FA confirming different dietary habits, which influenced the FA composition of cord plasma phospholipids and transitional breast milk. Since FA influence gene expression the found variation implies that the long-term follow-up of this cohort will be interesting.
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