Introduction: Helicobacter pylori infection is among the most common human infections and the major risk factor for peptic disease and gastric cancer. Immunization with vaccines containing the H pylori vacuolating cytotoxin A (VacA), cytotoxin-associated antigen (CagA), and neutrophil-activating protein(NAP), alone or in combination, have been shown to prevent experimental infection in animals. Aim: We sought to study the safety and immunogenicity of a vaccine consisting of recombinant VacA, CagA, and NAP given intramuscularly with aluminium hydroxide as an adjuvant to noninfected healthy subjects.Methods: This controlled, single-blind Phase I study randomized 57 H pylori-negative volunteers into 7 study arms exploring 2 dosages (10 and 25 g) of each antigen and 3 schedules (0, 1, 2 weeks; 0, 1, 2 months; and 0, 1, 4 months) versus alum controls. All participants were followed for 5 months. Thirty-six subjectsreceived a booster vaccination 18–24 months after the completion of the primary vaccination. Results: Local and systemic adverse reactions were mild and similar in placebo and vaccine recipients on the monthly schedules. All subjects responded to 1 or 2 of the antigens and 86% of all vaccines mounted immunoglobulinG antibody responses to all 3 antigens. Vaccinees exhibitedan antigen-specific cellular response. Vaccination 18–24 months later elicited anamnestic antibody and cellular responses. Conclusions: This intramuscular H pylori vaccine demonstrated satisfactory safety and immunogenicity, produced antigen-specific T-cell memory, and, therefore, warrants further clinical study.

Safety and immunogencity of an intramuscular Helicobacter pylori vaccine in noninfected volunteers: a phase I study / Malfertheiner, P.; Schultze, V.; Rosenkranz, B.; Kaufmann, S. H.; Ulrichs, T.; Novicki, D.; Norelli, F.; Contorni, M.; Peppoloni, Samuele; Berti, D.; Tornese, D.; Ganju, J.; Palla, E.; Rappuoli, R.; Scharschmidt, B. F.; Del Giudice, G.. - In: GASTROENTEROLOGY. - ISSN 0016-5085. - STAMPA. - 135 (3)(2008), pp. 787-795.

Safety and immunogencity of an intramuscular Helicobacter pylori vaccine in noninfected volunteers: a phase I study

PEPPOLONI, Samuele;
2008

Abstract

Introduction: Helicobacter pylori infection is among the most common human infections and the major risk factor for peptic disease and gastric cancer. Immunization with vaccines containing the H pylori vacuolating cytotoxin A (VacA), cytotoxin-associated antigen (CagA), and neutrophil-activating protein(NAP), alone or in combination, have been shown to prevent experimental infection in animals. Aim: We sought to study the safety and immunogenicity of a vaccine consisting of recombinant VacA, CagA, and NAP given intramuscularly with aluminium hydroxide as an adjuvant to noninfected healthy subjects.Methods: This controlled, single-blind Phase I study randomized 57 H pylori-negative volunteers into 7 study arms exploring 2 dosages (10 and 25 g) of each antigen and 3 schedules (0, 1, 2 weeks; 0, 1, 2 months; and 0, 1, 4 months) versus alum controls. All participants were followed for 5 months. Thirty-six subjectsreceived a booster vaccination 18–24 months after the completion of the primary vaccination. Results: Local and systemic adverse reactions were mild and similar in placebo and vaccine recipients on the monthly schedules. All subjects responded to 1 or 2 of the antigens and 86% of all vaccines mounted immunoglobulinG antibody responses to all 3 antigens. Vaccinees exhibitedan antigen-specific cellular response. Vaccination 18–24 months later elicited anamnestic antibody and cellular responses. Conclusions: This intramuscular H pylori vaccine demonstrated satisfactory safety and immunogenicity, produced antigen-specific T-cell memory, and, therefore, warrants further clinical study.
135 (3)
787
795
Safety and immunogencity of an intramuscular Helicobacter pylori vaccine in noninfected volunteers: a phase I study / Malfertheiner, P.; Schultze, V.; Rosenkranz, B.; Kaufmann, S. H.; Ulrichs, T.; Novicki, D.; Norelli, F.; Contorni, M.; Peppoloni, Samuele; Berti, D.; Tornese, D.; Ganju, J.; Palla, E.; Rappuoli, R.; Scharschmidt, B. F.; Del Giudice, G.. - In: GASTROENTEROLOGY. - ISSN 0016-5085. - STAMPA. - 135 (3)(2008), pp. 787-795.
Malfertheiner, P.; Schultze, V.; Rosenkranz, B.; Kaufmann, S. H.; Ulrichs, T.; Novicki, D.; Norelli, F.; Contorni, M.; Peppoloni, Samuele; Berti, D.; Tornese, D.; Ganju, J.; Palla, E.; Rappuoli, R.; Scharschmidt, B. F.; Del Giudice, G.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11380/613145
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