Katrina Nolan, United States of America

Merck & Co., Inc. Research

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Online Abstracts Clinical Sciences - Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults B5 Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults

SAFETY AND IMMUNOGENICITY OF V114 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE (PNEU-FLU)

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Presentation Topic
B5 Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults

Presenter of 1 Presentation

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HIGH THROUGHPUT ASSAYS FOR MEASURING IGG SEROTYPE-SPECIFIC ANTI-PNEUMOCOCCAL ANTIBODIES IN PHASE 3 CLINICAL TRIALS: THE BENEFITS OF A PROFICIENCY PANEL (ID 722)

Session Name
Vaccines - Pneumococcal Vaccines Development
Presenter
Authors

Abstract

Background

We previously validated a multiplex, ECL-based assay to quantify serotype-specific IgG to 15 serotypes included in an investigational PCV. To address challenges of maintaining the clinical assay for measurement of vaccine-induced antibodies in Phase 3 and beyond, we established a proficiency panel, the first of its kind for Merck serology assays.

Methods

The proficiency panel consists of 32 biobroker serum samples selected for antibody concentrations that span the quantifiable range for all vaccine serotypes. Baseline values were established across 12 months and were utilized in reagent stability and technology transfer protocols.

Results

Stability results support use of critical reagents for 2 years, extending expiry for plates and secondary antibody and allowing for flexible storage temperatures for secondary antibody. The technology transfer passed pre-specified acceptance criteria using manual methods, when compared against baseline values established using automation, enabling assay validation using both manual and automated methods.

Conclusions

Establishing a proficiency panel requires selection of appropriate samples, in large volume, and at least one year of testing to establish baseline values. This upfront investment enabled (1) expiry extension for critical reagents, resulting in overall time and cost savings, and (2) successful technology transfer and partial validation in another laboratory using both manual and automated methods.

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Author Of 3 Presentations

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HIGH THROUGHPUT MULTIPLEX URINE ANTIGEN DETECTION ASSAY FOR THE QUANTITATION OF SEROTYPE SPECIFIC PNEUMOCOCCAL POLYSACCHARIDES TO SUPPORT PNEUMOCOCCAL CONJUGATE VACCINE (PCV) PROGRAM (ID 1240)

Session Name
Vaccines - Pneumococcal Vaccines Development
Presenter
Authors

Abstract

Background

Streptococcus pneumoniae is the most common cause of community acquired pneumonia despite robust vaccinations. With ~100 serotypes (ST) in circulation, surveillance is crucial to estimate the ST specific disease burden and assess vaccine efficacy/coverage. To address these needs, we have developed a high throughput multiplex Pneumococcal Urine Antigen Detection (PnUAD) assay for the quantitation of 15 serotype specific polysaccharides (Ps) in human urine.

Methods

PnUAD was qualified based on the assay precision, ruggedness, specificity, accuracy, limit of detection, selectivity and dilutional linearity. Test samples were individual or pooled normal human urine spiked with full-length vaccine grade polysaccharides or fragmented polysaccharides (<150 kDa).

Results

PnUAD was determined to be serotype specific, precise (<15% RSD), accurate (80%-127% recovery throughout the quantifiable range), and dilutable (<2-fold dilution bias per 10-fold dilution) for each of the 15 Pn serotypes. The PnUAD was also determined to be highly sensitive (LLOQ ranging between 0.0020 – 0.0781 ng/mL across the 15 serotypes), and selective (consistent PnPs recovery for each ST when spiked into different pre-dilutions of urine).

Conclusions

PnUAD met all performance expectations, and is considered qualified to detect serotype specific PnPs in human urine in subjects from epidemiology studies or vaccine clinical trials.

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HIGH THROUGHPUT ASSAYS FOR MEASURING IGG SEROTYPE-SPECIFIC ANTI-PNEUMOCOCCAL ANTIBODIES IN PHASE 3 CLINICAL TRIALS: THE BENEFITS OF A PROFICIENCY PANEL (ID 722)

Session Name
Vaccines - Pneumococcal Vaccines Development
Presenter
Authors

Abstract

Background

We previously validated a multiplex, ECL-based assay to quantify serotype-specific IgG to 15 serotypes included in an investigational PCV. To address challenges of maintaining the clinical assay for measurement of vaccine-induced antibodies in Phase 3 and beyond, we established a proficiency panel, the first of its kind for Merck serology assays.

Methods

The proficiency panel consists of 32 biobroker serum samples selected for antibody concentrations that span the quantifiable range for all vaccine serotypes. Baseline values were established across 12 months and were utilized in reagent stability and technology transfer protocols.

Results

Stability results support use of critical reagents for 2 years, extending expiry for plates and secondary antibody and allowing for flexible storage temperatures for secondary antibody. The technology transfer passed pre-specified acceptance criteria using manual methods, when compared against baseline values established using automation, enabling assay validation using both manual and automated methods.

Conclusions

Establishing a proficiency panel requires selection of appropriate samples, in large volume, and at least one year of testing to establish baseline values. This upfront investment enabled (1) expiry extension for critical reagents, resulting in overall time and cost savings, and (2) successful technology transfer and partial validation in another laboratory using both manual and automated methods.

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SAFETY AND IMMUNOGENICITY OF V114 ADMINISTERED CONCOMITANTLY WITH INFLUENZA VACCINE (PNEU-FLU) (ID 619)

Session Name
Clinical Sciences - Treatment of Pneumococcal Disease in Infants, Children/Youth, and Adults
Presenter
Authors

Abstract

Background

Streptococcus pneumoniae and influenza virus are significant causes of disease worldwide. V114, an investigational 15-valent PCV, contains all serotypes in PCV13 plus serotypes 22F and 33F. This phase 3 trial evaluated safety and immunogenicity of concomitant and non-concomitant administration of V114 and quadrivalent influenza vaccine (QIV) in adults aged ≥50 years.

Methods

Overall, 1200 participants were randomized 1:1 to receive either V114 administered concomitantly with QIV (concomitant group) or V114 administered 1 month after QIV (non-concomitant group); randomization was stratified by age and history of prior pneumococcal polysaccharide vaccine. Pneumococcal serotype-specific opsonophagocytic activity (OPA) and influenza strain-specific hemagglutination inhibition (HAI) antibodies were measured prior and 30 days postvaccination. Demonstration of non-inferior immunogenicity between the concomitant and non-concomitant group required the lower bound of the 95% confidence interval of the ratio of OPA and HAI geometric mean titers (GMTs) to be ≥0.5.

Results

Proportions of participants reporting any AE, injection-site AEs, and systemic AEs were generally comparable between vaccination groups. Non-inferiority was demonstrated for all 15 pneumococcal serotypes and all 4 influenza strains between vaccination groups.

Conclusions

V114 administered concomitantly with QIV was generally well tolerated and immunologically non-inferior to non-concomitant administration, supporting co-administration of both vaccines.

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