Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine☆

Ockenhouse, Christian F.; Angov, Evelina; Kester, Kent E.; Diggs, Carter L.; Soisson, Lorraine; Cummings, James F.; Stewart, Ann; Palmer, Dupeh R.; Mahajan, Babita; Krzych, Urszula; Tornieporth, Nadia; Delchambre, Martine; Vanhandenhove, M; Ofori-Anyinam, Opokua; Cohen, Joe; Lyon, Jeffrey A.; Heppner, D. Gray

doi:10.1016/j.vaccine.2005.11.028

Cited by 91 publications

(106 citation statements)

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“…This brisk schedule proved to be well tolerated and was not associated with any new or higher incidence of AEs than had been observed in initial trials of FMP1/AS02A given on a 0-, 1-, and 3-month schedule in healthy malaria-naïve adults ( [18] and Cumming's unpublished data).…”

Section: Discussionmentioning

confidence: 75%

“…By the same token, we did not observe differences in endpoint titers against MSP-1 42 sub-fragments but we demonstrated a higher rate of antibody development against these peptides in FMP1/AS02A recipients. The FMP1/AS02A vaccine was highly immunogenic in the initial trials conducted in malaria-naïve adults in the USA ( [18] and Cumming's unpublished data). These data suggest that this vaccine will induce an even greater fold increase in anti-FMP1 titers when evaluated in children with lower baseline antibody titers.…”

Section: Discussionmentioning

confidence: 99%

“…Preclinical evaluation of FMP1 in the rhesus monkey safety and immunogenicity model identified AS02A as a safe, well-tolerated, and highly immunogenic adjuvant [17]. FMP1 formulated with GlaxoSmithKline's proprietary adjuvant AS02A proved safe and immunogenic in two previous trials conducted in 60 malaria naïve volunteers in the USA ( [18] and Cumming's unpublished data). The study presented here, the first Phase 1 trial of FMP1/AS02A in a malaria-experienced population, provides further safety and immunogenicity data as part of a clinical development plan that aims to develop vaccines to prevent disease in children.…”

Section: Introductionmentioning

confidence: 94%

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Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

Stoute

Gombe

Withers

et al. 2007

Vaccine

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randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya" (2007 AbstractWe report the first trial of candidate malaria vaccine antigen FMP1, a 42 kDa fragment from the C-terminus of merozoite surface protein-1 (MSP-1) from the 3D7 strain of Plasmodium falciparum, in an endemic area. Forty adult male and female residents of western Kenya were enrolled to receive 3 doses of either FMP1/AS02A or Imovax ® rabies vaccine by intra-deltoid injection on a 0, 1, 2 month schedule. Thirty-seven volunteers received all three immunizations and 38 completed the 12-month evaluation period. Slightly more recipients of the FMP1/AS02A vaccine experienced any instance of pain at 24 h post-immunization than in the Imovax ® group This document is a U.S. government work and is not subject to copyright in the United States. J. A. Stoute et al. / Vaccine 25 (2007) 176-184 177 (95% versus 65%), but otherwise the two vaccines were equally safe and well-tolerated. Baseline antibody levels were high in both groups and were boosted in the FMP1/AS02A group. Longitudinal models revealed a highly significant difference between groups for both the average post-baseline antibody responses to MSP-1 42 (F 1,335 = 13.16; P < 0.001) and the Day 90 responses to MSP-1 42 (F 1,335 = 16.69; P < 0.001). The FMP1/AS02A vaccine is safe and immunogenic in adults and should progress to safety testing in children at greatest risk of malaria. Published by Elsevier Ltd.

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Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 94%

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Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

Stoute

Gombe

Withers

et al. 2007

Vaccine

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“…The vaccine was shown to be safe and created minimum reactogenicity with no severe adverse effects in all subjects. A high titre of parasite-reactive anti-MSP-1 antibodies was induced and 80% of immunizedsubject sera reached the minimum functional inhibitory level of 15% inhibition in parasite growth inhibition assay (65). The same vaccine was evaluated in the falciparummalaria endemic areas, including western Kenya (66) and Mali (67), with 40 adult volunteers in a Phase I trial.…”

Section: Msp-1 In Human Trialsmentioning

confidence: 99%

Immunogenicity of the Merozoite Surface Protein-1 (Msp-1) of Human Plasmodium Sp.

Yl¹,

Fw²,

My³

2015

JUMMEC

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Malaria is a major cause of mortality and morbidity globally. Great efforts have been made in the prevention and the elimination of malaria, especially in controlling the malaria vector, the mosquito. Another promising approach would be the development of malaria vaccines. Malaria vaccine studies can be focused on the pre-erythrocytic-stage antigens and the blood-stage antigens, and on the transmission blocking agents targeting the malaria gametocytes. The blood-stage antigens are the leading candidates in malaria vaccine development, as the blood-stage parasites are responsible for causing symptomatic malaria. Human acquired immunity largely targets on blood-stage antigens. This review focuses on one of the most extensively studied blood-stage antigen, the merozoite surface protein-1 (MSP-1), specifically on its evaluation and immunogenicity in rodents and primate models, and its safety and immunogenicity in human clinical trials.

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“…Highlighted in this section are the most frequently targeted of those antigens: -MSP-1: the properties and functions of this antigen will be discussed in detail in Section 5 since this antigen represents a major blood stage vaccine candidate (Ockenhouse et al, 2006;Ogutu et al, 2009). -MSP-2: immunization with the recombinant protein MSP-2 protects non-human primates and has yielded allele-specific reduced parasite density in field studies (Genton et al, 2002).…”

Section: Merozoite Surface Coat Antigensmentioning

confidence: 99%

The Impact of Immune Responses on the Asexual Erythrocytic Stages of Plasmodium and the Implication for Vaccine Development

Bergmann‐Leitner¹,

Duncan²,

Angov³

2012

Malaria Parasites

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Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine☆

Cited by 91 publications

References 41 publications

Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

Immunogenicity of the Merozoite Surface Protein-1 (Msp-1) of Human Plasmodium Sp.

The Impact of Immune Responses on the Asexual Erythrocytic Stages of Plasmodium and the Implication for Vaccine Development

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