Literature DB >> 19410624

A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel with CPG 7909, using two different formulations and dosing intervals.

Ruth D Ellis1, Gregory E D Mullen, Mark Pierce, Laura B Martin, Kazutoyo Miura, Michael P Fay, Carole A Long, Donna Shaffer, Allan Saul, Louis H Miller, Anna P Durbin.   

Abstract

A Phase 1 study was conducted in 24 malaria naïve adults to assess the safety and immunogenicity of the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with CPG 7909 in two different formulations (phosphate buffer and saline), and given at two different dosing schedules, 0 and 1 month or 0 and 2 months. Both formulations were well tolerated and frequency of local reactions and solicited adverse events was similar among the groups. Peak antibody levels in the groups receiving CPG 7909 in saline were not significantly different than those receiving CPG 7909 in phosphate. Peak antibody levels in the groups vaccinated at a 0,2 month interval were 2.52-fold higher than those vaccinated at a 0,1 month interval (p=0.037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85% (0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p=0.056).

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Year:  2009        PMID: 19410624      PMCID: PMC2722923          DOI: 10.1016/j.vaccine.2009.04.077

Source DB:  PubMed          Journal:  Vaccine        ISSN: 0264-410X            Impact factor:   3.641


  27 in total

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5.  In vitro studies with recombinant Plasmodium falciparum apical membrane antigen 1 (AMA1): production and activity of an AMA1 vaccine and generation of a multiallelic response.

Authors:  Michael C Kennedy; Jin Wang; Yanling Zhang; Aaron P Miles; Farideh Chitsaz; Allan Saul; Carole A Long; Louis H Miller; Anthony W Stowers
Journal:  Infect Immun       Date:  2002-12       Impact factor: 3.441

6.  A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali.

Authors:  Issaka Sagara; Alassane Dicko; Ruth D Ellis; Michael P Fay; Sory I Diawara; Mahamadoun H Assadou; Mahamadou S Sissoko; Mamady Kone; Abdoulbaki I Diallo; Renion Saye; Merepen A Guindo; Ousmane Kante; Mohamed B Niambele; Kazutoyo Miura; Gregory E D Mullen; Mark Pierce; Laura B Martin; Amagana Dolo; Dapa A Diallo; Ogobara K Doumbo; Louis H Miller; Allan Saul
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Authors:  Jeffrey A Lyon; Evelina Angov; Michael P Fay; JoAnn S Sullivan; Autumn S Girourd; Sally J Robinson; Elke S Bergmann-Leitner; Elizabeth H Duncan; Christian A Darko; William E Collins; Carole A Long; John W Barnwell
Journal:  PLoS One       Date:  2008-07-30       Impact factor: 3.240

10.  Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria.

Authors:  Gregory E D Mullen; Ruth D Ellis; Kazutoyo Miura; Elissa Malkin; Caroline Nolan; Mhorag Hay; Michael P Fay; Allan Saul; Daming Zhu; Kelly Rausch; Samuel Moretz; Hong Zhou; Carole A Long; Louis H Miller; John Treanor
Journal:  PLoS One       Date:  2008-08-13       Impact factor: 3.240

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  28 in total

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2.  Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali.

Authors:  Ruth D Ellis; Issaka Sagara; Anna Durbin; Alassane Dicko; Donna Shaffer; Louis Miller; Mahamadoun H Assadou; Mamady Kone; Beh Kamate; Ousmane Guindo; Michael P Fay; Dapa A Diallo; Ogobara K Doumbo; Ezekiel J Emanuel; Joseph Millum
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5.  Lack of allele-specific efficacy of a bivalent AMA1 malaria vaccine.

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6.  A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults.

Authors:  Issaka Sagara; Ruth D Ellis; Alassane Dicko; Mohamed B Niambele; Beh Kamate; Ousmane Guindo; Mahamadou S Sissoko; Michael P Fay; Merepen A Guindo; Ousmane Kante; Renion Saye; Kazutoyo Miura; Carole Long; Gregory E D Mullen; Mark Pierce; Laura B Martin; Kelly Rausch; Amagana Dolo; Dapa A Diallo; Louis H Miller; Ogobara K Doumbo
Journal:  Vaccine       Date:  2009-10-27       Impact factor: 3.641

7.  Comparison of the immunological responses and efficacy of gamma-irradiated V3526 vaccine formulations against subcutaneous and aerosol challenge with Venezuelan equine encephalitis virus subtype IAB.

Authors:  Shannon S Martin; Russell R Bakken; Cathleen M Lind; Patricia Garcia; Erin Jenkins; Pamela J Glass; Michael D Parker; Mary Kate Hart; Donald L Fine
Journal:  Vaccine       Date:  2009-11-13       Impact factor: 3.641

Review 8.  Clinical evaluation of CpG oligonucleotides as adjuvants for vaccines targeting infectious diseases and cancer.

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Journal:  Vaccine       Date:  2014-06-24       Impact factor: 3.641

Review 9.  Recent progress concerning CpG DNA and its use as a vaccine adjuvant.

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10.  Phase 1 trial of the Plasmodium falciparum blood stage vaccine MSP1(42)-C1/Alhydrogel with and without CPG 7909 in malaria naïve adults.

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Journal:  PLoS One       Date:  2010-01-22       Impact factor: 3.240

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