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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0000-131 | Other Identifier | Merck |
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This study evaluated whether it is possible in healthy elderly participants to generate baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute serum antibody titer) using each of the protocol selected vaccines separately; and examined the rank correlation coefficients of pairs of post vaccination antibody titers within the same elderly individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Healthy, elderly participants | Healthy participants 65 years old and older. |
| |
| Arm 2: Healthy, young, participants | Healthy participants 25 to 40 years old. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus & Diphtheria booster vaccine (Td) | Biological | Tetanus & Diphtheria booster vaccine (Td), single intramuscular dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Baseline and 1 month after final vaccination |
| Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Baseline and 1 month after final vaccination |
| Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 25 to 40 years old or 65 years and older
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| Name | Affiliation | Role |
|---|---|---|
| Francois St-Maurice, MD | Anapharm | Principal Investigator |
| Denis Audet, MD | Anapharm | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Younger Participants | Participants 25 to 40 years of age. |
| FG001 | Elderly Participants | Participants 65 years old and older. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Younger Participants | Aged 25 to 40 years old |
| BG001 | Elderly Participants | Aged 65 years and older |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Baseline and 1 month after final vaccination |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants who received at least one dose of each vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | MedDRA 15.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D017325 | Hepatitis B Vaccines |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
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Cryopreserved peripheral blood mononuclear cells (PBMCs) obtained from whole blood samples.
| TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] | Biological | TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], intramuscular, two doses of standard three dose regimen (opposite arms) |
|
| Dukoral® Traveler's Diarrhea Vaccine (WC/rBS) | Biological | Dukoral® Traveler's Diarrhea Vaccine, recombinant Cholera toxin B subunit (WC/rBS), standard two oral doses per treatment regimen |
|
| Baseline and 1 month after final vaccination |
| Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Baseline and 3 weeks after final vaccination |
| Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). | 3 weeks or 1 month after each final vaccination |
| Day 7 and 1 month after final vaccination |
| Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln). | Day 7 and 1 month after each final vaccination |
| Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln). | Day 7 and 1 month after final vaccination |
| Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln). | Day 7 and 3 weeks after final vaccination |
| BG002 |
| Total |
Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Elderly Participants | Healthy participants 65 years of age and older. |
|
|
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| Primary | Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Baseline and 1 month after final vaccination |
|
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|
| Primary | Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Baseline and 1 month after final vaccination |
|
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| Primary | Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Baseline and 3 weeks after final vaccination |
|
|
|
|
| Primary | Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | 3 weeks or 1 month after each final vaccination |
|
|
|
|
| Secondary | Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Day 7 and 1 month after final vaccination |
|
|
|
|
| Secondary | Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Day 7 and 1 month after each final vaccination |
|
|
|
|
| Secondary | Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Day 7 and 1 month after final vaccination |
|
|
|
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| Secondary | Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants. | Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized "international units" of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln). | Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported. | Posted | Mean | Standard Deviation | ln International Units | Day 7 and 3 weeks after final vaccination |
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| 0 |
| 174 |
| 14 |
| 174 |
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D014765 |
| Viral Vaccines |
| Title | Measurements |
|---|---|
|
| Cholera |
|
| Fisher's Z-transformation |
| 0.26 |
| Spearman's Correlation Coefficient |
| 0.10 |
| 2-Sided |
| 95 |
| -0.07 |
| 0.25 |
Within-participant rank correlation |
| No |
| Superiority or Other |
| Diphtheria versus Tetanus | Fisher's Z-transformation | <0.001 | Spearman's Correlation Coefficient | 0.40 | 2-Sided | 95 | 0.26 | 0.53 | Within-participant rank correlation | No | Superiority or Other |
| Hepatitis B versus Cholera | Fisher's Z-transformation | 0.04 | Spearman's Correlation Coefficient | -0.17 | 2-Sided | 95 | -0.32 | -0.01 | Within-participant rank correlation | No | Superiority or Other |
| Hepatitis B versus Tetanus | Fisher's Z-transformation | 0.30 | Spearman's Correlation Coefficient | -0.09 | 2-Sided | 95 | -0.25 | 0.08 | Within-participant rank correlation | No | Superiority or Other |
| Cholera versus Tetanus | Fisher's Z-transformation | 0.36 | Spearman's Correlation Coefficient | 0.08 | 2-Sided | 95 | -0.09 | 0.24 | Within-participant rank correlation | No | Superiority or Other |