Multicenter study for the evaluation of the antibody response against salmonella typhi Vi vaccination (EMPATHY) for the diagnosis of Anti -polysaccharide antibody production deficiency in patients with primary immunodeficiency

Sánchez-Ramón, Silvia; Gracia, Javier de; García-Alonso, A.M.; Molina, Juan; Melero, Josefa; Andrés, Ana De; Morales, José María García Ruiz de; Ferreira, Antônio Walter; Ocejo-Vinyals, Javier Gonzalo; Cid, Javier; Martinez, Juan; Lasheras, T; Vargas, Marı́a Luisa; Gil-Herrera, Juana; Rodrı́guez, Marı́a C.; Castañer, J.; Granado, L.I. González; Allende, Luís M.; Soler‐Palacín, Pere; Herráiz, L; López-Hoyos, Marcos; Bellón, José M.; G, Silva; Gurbindo, Dolores; Carbone, J.; Rodríguez-Sáinz, Carmen; Matamoros, N.; Parker, Antony R.; Fernández‐Cruz, Eduardo

doi:10.1016/j.clim.2016.05.006

Cited by 33 publications

(43 citation statements)

References 18 publications

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“…However, pneumococcal response was assessed by a commercial PPV-coated ELISA and these ELISAs, measuring a combined IgG response, have limited value to diagnose patients with SAD (13). Using the same commercial ELISA kit for S. typhi Vi vaccine, Sánchez-Ramón and colleagues found a minimum postvaccination IgG concentration of 32 and 7.4 U/ml and minimum fold increase of 3.4 and 1 in a healthy and Common Variable Immunodeficiency group, respectively, which shows that our proposed criteria discriminate healthy subjects from SAD subjects (16). Ferry et al found a greater than threefold increase in 95% of 23 healthy vaccinated individuals, using an in-house ELISA (15).…”

Section: Discussionmentioning

confidence: 75%

“…We, thereby, addressed three major limitations of previous studies describing S. typhi Vi antibody responses: limited number of healthy individuals studied (15, 16), use of an in-house hence not widely available ELISA (15), radio-immuno assay (31), or bead-based assay (32) for detection of anti- S. typhi Vi antibodies and restricted age groups [in children 2–16 years (33) or 2–5 years (34) old]. A comparison of pneumococcal polysaccharide antibody response and S. typhi Vi vaccine response was recently conducted in 16 healthy volunteers, 22 common variable immunodeficiency patients, and 27 hypogammaglobulinemic patients and showed superiority of anti- S. typhi Vi vaccine responses to discriminate between groups.…”

Section: Discussionmentioning

confidence: 99%

“…S. typhi Vi vaccine contains purified Vi capsular polysaccharide of S. typhi , to which the specific antibody response can reliably be measured by ELISA (15, 16). Seroconversion rates were described in two small healthy cohorts [ N = 26 (15) and N = 16 (16)]; the results were not compared to the gold standard pneumococcal antibody assay.…”

Section: Introductionmentioning

confidence: 99%

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Fifth Percentile Cutoff Values for Antipneumococcal Polysaccharide and Anti-Salmonella typhi Vi IgG Describe a Normal Polysaccharide Response

et al. 2017

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BackgroundSerotype-specific antibody responses to unconjugated pneumococcal polysaccharide vaccine (PPV) evaluated by a World Health Organization (WHO)-standardized enzyme-linked immunosorbent assay (ELISA) are the gold standard for diagnosis of specific polysaccharide antibody deficiency (SAD). The American Academy of Allergy, Asthma and Immunology (AAAAI) has proposed guidelines to interpret the PPV response measured by ELISA, but these are based on limited evidence. Additionally, ELISA is costly and labor-intensive. Measurement of antibody response to Salmonella typhi (S. typhi) Vi vaccine and serum allohemagglutinins (AHA) have been suggested as alternatives. However, there are no large cohort studies and cutoff values are lacking.ObjectiveTo establish cutoff values for antipneumococcal polysaccharide antibody response, anti-S. typhi Vi antibody, and AHA.MethodsOne hundred healthy subjects (10–55 years) were vaccinated with PPV and S. typhi Vi vaccine. Blood samples were obtained prior to and 3–4 weeks after vaccination. Polysaccharide responses to 3 serotypes were measured by WHO ELISA and to 12 serotypes by an in-house bead-based multiplex assay. Anti-S. typhi Vi IgG were measured with a commercial ELISA kit. AHA were measured by agglutination method.ResultsApplying AAAAI criteria, 30% of healthy subjects had a SAD. Using serotype-specific fifth percentile (p5) cutoff values for postvaccination IgG and fold increase pre- over postvaccination, only 4% of subjects had SAD. One-sided 95% prediction intervals for anti-S. typhi Vi postvaccination IgG (≥11.2 U/ml) and fold increase (≥2) were established. Eight percent had a response to S. typhi Vi vaccine below these cutoffs. AHA titer p5 cutoffs were ½ for anti-B and ¼ for anti-A.ConclusionWe establish reference cutoff values for interpretation of PPV response measured by bead-based assay, cutoff values for S. typhi Vi vaccine responses, and normal values for AHA. For the first time, the intraindividual consistency of all three methods is studied in a large cohort.

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Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Fifth Percentile Cutoff Values for Antipneumococcal Polysaccharide and Anti-Salmonella typhi Vi IgG Describe a Normal Polysaccharide Response

et al. 2017

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“…The vaccines are targeted to the capsular polysaccharide Vi antigen [5]. Measurement of Typhi Vi antibodies may be a suitable additional candidate for the assessment of the response to polysaccharide antigens because (1) interpretation is less complicated due to lack of multiple serotypic components and thus less cross reactivity, (2) there is no conjugated polysaccharide vaccine currently in routine use globally, and (3) the pre Typhi Vi vaccination concentrations should be generally low in most populations [6, 7, 8]. …”

Section: Introductionmentioning

confidence: 99%

“…Sanchez-Ramon et al recently reported that a 3FI could aid differentiation of patients with common variable immunodeficiency (CVID) from healthy volunteers and those with hypogammaglobulinemia (HYPO) [8].…”

Section: Introductionmentioning

confidence: 99%

The response to Typhi Vi vaccination is compromised in individuals with primary immunodeficiency

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Senaratne

et al. 2017

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Measurement of an individuals ability to respond to polysaccharide antigens is a crucial test to determine adaptive immunity. Currently the response to Pneumovax® is utilized but with the success of Prevnar®, measurement of the response to Pneumovax may be challenging. The aim of the study was to assess the response to Typhi Vi vaccination in both children and adult control groups and patients with primary immunodeficiency (PID). In the control groups, >95% of the individuals had pre Typhi Vi vaccination concentrations <100 U/mL and there was significant increase in concentration post Typhi Vi vaccination (p<0.0001) with>94% achieving ≥3 fold increase in concentration (FI). The response to Typhi Vi vaccination was significantly lower in both children (p = 0.006) and adult (p = 0.002) PID groups when compared to their control groups. 11% and 55% of the children and adult PID groups respectively did not obtain a response >3FI. There were no significant differences between the responses obtained in the children and adult PID groups. When all individuals with PID were separated into those with either hypogammaglobulinemia (HYPO) or common variable immunodeficiency (CVID), both groups had a significantly lower median FI than the control group (19, 95%CI 5–56 vs 59, 95%CI 7–237; p = 0.01 and 1, 95%CI 1–56 vs 32, 95%CI 5–136; p = 0.005). Further, a >3FI differentiated the antibody responses between both the CVID and HYPO groups and their control groups (AUC: 0.83, 95%CI: 0.65–1.00, p = 0.005 and 0.81, 95% CI: 0.65–0.97, p = 0.01). The data suggests that measurement of the response to Typhi Vi vaccination could represent a complementary assay for the assessment of the response to a polysaccharide vaccine.

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The Use of Salmonella Typhim Vaccine to Diagnose Antibody Deficiency

et al. 2017

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Multicenter study for the evaluation of the antibody response against salmonella typhi Vi vaccination (EMPATHY) for the diagnosis of Anti -polysaccharide antibody production deficiency in patients with primary immunodeficiency

Cited by 33 publications

References 18 publications

Fifth Percentile Cutoff Values for Antipneumococcal Polysaccharide and Anti-Salmonella typhi Vi IgG Describe a Normal Polysaccharide Response

Fifth Percentile Cutoff Values for Antipneumococcal Polysaccharide and Anti-Salmonella typhi Vi IgG Describe a Normal Polysaccharide Response

The response to Typhi Vi vaccination is compromised in individuals with primary immunodeficiency

The Use of Salmonella Typhim Vaccine to Diagnose Antibody Deficiency

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