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This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Participants will receive a single dose of Tdap vaccine (Adacel) every 3 months for a total of 5 immunizations over a period of 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adacel | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as an adverse event occurring after first study treatment. A serious TEAE was defined as an AE that resulted in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, an important medical event that based on appropriate medical judgment may jeopardize the subject and may require medical or surgical intervention to prevent one of the aforementioned outcomes. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tetanus Antibody Titers in Participants Over Time | Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time. | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 18 |
| Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GCAM Eagle Pass Center | Eagle Pass | Texas | 78852 | United States | ||
| GCAM Laredo Center |
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All participants were "Qualified Donors" who had been qualified for continued plasma donations in accordance with Donor Eligibility requirements found in 21 CFR 630.10 and 630.15, and Source Plasma regulations under 21 CRF 640, Subpart G. A total of 110 participants were consented and screened for eligibility. Ten of these did not meet eligibility criteria.
Participants between the ages of 18 to 63 years old were recruited from the Laredo, Texas area during February through May, 2020, without regard to ethnicity, race, or socioeconomic level. Standard recruiting practices such as IRB-approved flyers were used to recruit study volunteers
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| ID | Title | Description |
|---|---|---|
| FG000 | Tdap Vaccine | The vaccine was administered every 3 months ± 1 week for 12 months (5 vaccinations) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tdap Vaccine | The vaccine was administered every 3 months ± 1 week for 12 months (5 vaccinations) |
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as an adverse event occurring after first study treatment. A serious TEAE was defined as an AE that resulted in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, an important medical event that based on appropriate medical judgment may jeopardize the subject and may require medical or surgical intervention to prevent one of the aforementioned outcomes. | Population included all enrolled participants who received at least one vaccination and had safety data. | Posted | Number | participants | Up to 18 months |
|
1 year, 6 months
AEs and serious adverse events (SAEs) were collected starting with the initiation of the first study vaccination through study month 18, documented in the source records, and entered into the eCRFs using accepted medical terms and/or the diagnosis that accurately characterized the event.
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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 | Tdap Vaccine | Tdap vaccine 0.5 mL administered intramuscularly on Day 0, Month 3, Month 6, Month 9 and Month 12. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Center Medical Director | GCAM / Biomat USA - Grifols | 956-729-7677 | laredomedical@gcamplasma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 30, 2020 | Aug 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2021 | Aug 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C509326 | adacel |
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The numbers and percentages of participants whose post vaccination antibody levels were <5 IU/mL; ≥5 IU/mL to 10 IU/mL; >10 IU/mL to 15 IU/mL; and, >15 IU/mL after each vaccination. |
| Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 18 |
| Laredo |
| Texas |
| 78040 |
| United States |
| Adverse Event |
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| No longer eligible |
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| Screen Failure |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Tdap vaccine 0.5 mL administered intramuscularly on Day 0, Month 3, Month 6, Month 9 and Month 12. |
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| Secondary | Anti-tetanus Antibody Titers in Participants Over Time | Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time. | Multiple participants dropped out of the study early. Missing data were documented in the protocol deviations and summary statistics to reflect the number of observations for which data were provided. No missing data were derived. | Posted | Geometric Mean | Standard Deviation | Titers (IU/mL) | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 18 |
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| Secondary | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | The numbers and percentages of participants whose post vaccination antibody levels were <5 IU/mL; ≥5 IU/mL to 10 IU/mL; >10 IU/mL to 15 IU/mL; and, >15 IU/mL after each vaccination. | Multiple participants dropped out of the study early. Missing data were documented in the protocol deviations and summary statistics to reflect the number of observations for which data were provided. No missing data were derived. | Posted | Count of Participants | Participants | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 18 |
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| 0 |
| 100 |
| 0 |
| 100 |
| 71 |
| 100 |
| Injection site bruising | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Red blood cells urine positive | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Urine leukocyte esterase positive | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Hemoglobin urine present | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Glucose urine present | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Urine ketone body present | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| D007239 | Infections |
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| ≥ 10 to 15 IU/mL |
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| ≥ 15 IU/mL |
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