Safety and Immunogenicity of a Malaria Vaccine, Plasmodium falciparum AMA-1/MSP-1 Chimeric Protein Formulated in Montanide ISA 720 in Healthy Adults

التفاصيل البيبلوغرافية
العنوان: Safety and Immunogenicity of a Malaria Vaccine, Plasmodium falciparum AMA-1/MSP-1 Chimeric Protein Formulated in Montanide ISA 720 in Healthy Adults
المؤلفون: Jia He, Jun Gu, Qiang Wang, Xuegong Pan, Wenjie Li, Li Qu, Yongmei Zhu, Haitao Liu, Xiangyang Xue, Zhifang Cao, Dongmei Zhang, Zarifah Reed, Marie-Paule Kieny, Zhen Li, Qian Shen, Yang Cao, Qingfeng Zhang, Mobin Wan, Zhihui Chen, Jinhong Hu, Xiudong Huang, Weiqing Pan
المصدر: PLoS ONE
PLoS ONE, Vol 3, Iss 4, p e1952 (2008)
بيانات النشر: Public Library of Science, 2008.
سنة النشر: 2008
مصطلحات موضوعية: Adult, Male, Adolescent, medicine.medical_treatment, Recombinant Fusion Proteins, Population, Plasmodium falciparum, Protozoan Proteins, lcsh:Medicine, Antigens, Protozoan, Oleic Acids, Antigen, Immunity, Immunology/Immunity to Infections, parasitic diseases, Malaria Vaccines, medicine, Animals, Humans, Mannitol, Malaria, Falciparum, lcsh:Science, education, Merozoite Surface Protein 1, education.field_of_study, Multidisciplinary, biology, business.industry, Malaria vaccine, Immunogenicity, lcsh:R, Infectious Diseases/Protozoal Infections, Membrane Proteins, Middle Aged, medicine.disease, biology.organism_classification, Virology, Protein Subunits, Immunology, Immunology/Immune Response, lcsh:Q, Female, Safety, business, Adjuvant, Malaria, Research Article, Infectious Diseases/Tropical and Travel-Associated Diseases
الوصف: 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].
اللغة: English
تدمد: 1932-6203
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d1c75427b72ddfdd87065333bf9d0952
http://europepmc.org/articles/PMC2276862
Rights: OPEN
رقم الانضمام: edsair.doi.dedup.....d1c75427b72ddfdd87065333bf9d0952
قاعدة البيانات: OpenAIRE