Phase I Safety and Immunogenicity Trial of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51

Herrera, Sócrates; Fernández, Olga Lucía; Vera, Omaira; Cárdenas, William; Ramírez, Óscar; Palácios, Ricardo; Chen-Mok, Mario; Corradin, Giampietro; Arévalo‐Herrera, Myriam

doi:10.4269/ajtmh.2011.09-0516

Cited by 68 publications

(63 citation statements)

References 55 publications

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“…We had the opportunity to test similar vaccine formulations in mice and monkeys, and later on in humans. 31 The reproducibility of the data obtained here with previous studies 6 using similar synthetic protein fragments is encouraging for further vaccine testing. In preliminary studies we had tested the immunogenicity of the individual synthetic protein fragments individually, both in animals and humans, 6,20 with the rationale of selecting the most immunogenic and functionally active CS protein domain.…”

Section: Discussionsupporting

confidence: 76%

Preclinical Vaccine Study of Plasmodium vivax Circumsporozoite Protein Derived-Synthetic Polypeptides Formulated in Montanide ISA 720 and Montanide ISA 51 Adjuvants

Arévalo‐Herrera¹,

Vera²,

Castellanos³

et al. 2011

The American Journal of Tropical Medicine and Hygiene

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Section: Discussionsupporting

confidence: 76%

Preclinical Vaccine Study of Plasmodium vivax Circumsporozoite Protein Derived-Synthetic Polypeptides Formulated in Montanide ISA 720 and Montanide ISA 51 Adjuvants

Arévalo‐Herrera¹,

Vera²,

Castellanos³

et al. 2011

The American Journal of Tropical Medicine and Hygiene

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“…Interestingly, no cohort study examined the protective effect of antibody responses to either the preerythrocytic antigen PvCSP or the gametocyte antigen Pvs25. Both of these have previously been assessed in Phase I trials [6,[71][72][73], and PfCSP comprises the current Phase III P. falciparum vaccine RTS,S, which has demonstrated around 50% efficacy in young children and around 30% efficacy in infants [15,16]. This review shows that very few antigens meet the pre-clinical criteria for prioritizing candidate antigens (targets of protective immunity in humans) for vaccine development, which is particularly pertinent given the difficulties in meeting other in vitro pre-clinical criteria (demonstrating essential/important function, abundance, limited genetic diversity, inhibition of parasite growth, protection in animal models of infection) [7] because of difficulties in maintaining P. vivax in culture.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, only two P. vivax vaccine candidates (Pv Duffy binding protein (PvDBP) and Pv circumsporozoite protein PvCSP) are in clinical trials (Phase I) compared with 23 P. falciparum vaccine candidates (including one in Phase III trials: RTS,S) [5,6]. This may reflect the previous neglect of P. vivax, the difficulty in maintaining P. vivax in culture, and the limited animal models of infection currently available.…”

Section: Introductionmentioning

confidence: 99%

Immunological markers of Plasmodium vivax exposure and immunity: a systematic review and meta-analysis

Cutts¹,

Powell²,

Agius³

et al. 2014

BMC Medicine

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Background: Identifying Plasmodium vivax antigen-specific antibodies associated with P. vivax infection and protective immunity is key to the development of serosurveillance tools and vaccines for malaria. Antibody targets of P. vivax can be identified by seroepidemiological studies of individuals living in P. vivax-endemic areas, and is an important strategy given the limited ability to culture P. vivax in vitro. There have been numerous studies investigating the association between P. vivax antibody responses and P. vivax infection, but there has been no standardization of results to enable comparisons across populations. Methods: We performed a systematic review with meta-analysis of population-based, cross-sectional, case-control, and cohort studies of individuals living in P. vivax-endemic areas. We searched 6 databases and identified 18 studies that met predefined inclusion and quality criteria, and examined the association between antibody responses to P. vivax antigens and P. vivax malaria.

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“…For Montanide ISA 51, though little to no reactogenicity has been reported in animal studies and in some human studies [41,50-52], other human studies have concluded that this adjuvant, with its current composition, might not be suitable for use in humans due to high reactogenicity [42,43]. …”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of multi-antigen AMA1-based vaccines formulated with CoVaccine HT™ and Montanide ISA 51 in rhesus macaques

Kusi

Remarque

Riasat

et al. 2011

Malar J

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BackgroundIncreasing the breadth of the functional antibody response through immunization with Plasmodium falciparum apical membrane antigen 1 (PfAMA1) multi-allele vaccine formulations has been demonstrated in several rodent and rabbit studies. This study assesses the safety and immunogenicity of three PfAMA1 Diversity-Covering (DiCo) vaccine candidates formulated as an equimolar mixture (DiCo mix) in CoVaccine HT™ or Montanide ISA 51, as well as that of a PfAMA1-MSP119 fusion protein formulated in Montanide ISA 51.MethodsVaccine safety in rhesus macaques was monitored by animal behaviour observation and assessment of organ and systemic functions through clinical chemistry and haematology measurements. The immunogenicity of vaccine formulations was assessed by enzyme-linked immunosorbent assays and in vitro parasite growth inhibition assays with three culture-adapted P. falciparum strains.ResultsThese data show that both adjuvants were well tolerated with only transient changes in a few of the chemical and haematological parameters measured. DiCo mix formulated in CoVaccine HT™ proved immunologically and functionally superior to the same candidate formulated in Montanide ISA 51. Immunological data from the fusion protein candidate was however difficult to interpret as four out of six immunized animals were non-responsive for unknown reasons.ConclusionsThe study highlights the safety and immunological benefits of DiCo mix as a potential human vaccine against blood stage malaria, especially when formulated in CoVaccine HT™, and adds to the accumulating data on the specificity broadening effects of DiCo mix.

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Phase I Safety and Immunogenicity Trial of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51

Cited by 68 publications

References 55 publications

Preclinical Vaccine Study of Plasmodium vivax Circumsporozoite Protein Derived-Synthetic Polypeptides Formulated in Montanide ISA 720 and Montanide ISA 51 Adjuvants

Preclinical Vaccine Study of Plasmodium vivax Circumsporozoite Protein Derived-Synthetic Polypeptides Formulated in Montanide ISA 720 and Montanide ISA 51 Adjuvants

Immunological markers of Plasmodium vivax exposure and immunity: a systematic review and meta-analysis

Safety and immunogenicity of multi-antigen AMA1-based vaccines formulated with CoVaccine HT™ and Montanide ISA 51 in rhesus macaques

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