Tetanus
Conditions
Brief summary
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.
Interventions
BIOLOGICALAdacel
0.5 mL, Intramuscular
Sponsors
GCAM Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 63 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female ages 18 to 63 years * Females of childbearing potential who agree to employ adequate birth control measures during the study * Signed the informed consent form (ICF) * Met all of the criteria required by GCAM to be a Normal Source Plasma donor * Subject is not participating in any other immunization program
Exclusion criteria
* Subject is pregnant * Subject has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data * Subject has repeated reactions or hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.) * Subject has history of a severe reaction to any immunization * Subject has a history of Guillain-Barré Syndrome * The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tetanus Antibody Titers in Participants 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 | Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time. |
| Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Tdap Vaccine The vaccine was administered every 3 months ± 1 week for 12 months (5 vaccinations) | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 73 |
| Overall Study | No longer eligible | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen Failure | 10 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Tdap Vaccine |
|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 9.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 100 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 71 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
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.
Time frame: Up to 18 months
Population: Population included all enrolled participants who received at least one vaccination and had safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap Vaccine | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Number of participants with at least one TEAE | 71 participants |
| Tdap Vaccine | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Number of participants with at least one TEAE related to the study product | 42 participants |
| Tdap Vaccine | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Number of participants with at least one serious TEAE | 0 participants |
Secondary
Anti-tetanus Antibody Titers in Participants Over Time
Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Screening | 1.2 Titers (IU/mL) | Standard Deviation 1.29 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 1 | 13.2 Titers (IU/mL) | Standard Deviation 0.74 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 2 | 8.1 Titers (IU/mL) | Standard Deviation 0.89 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 3 | 5.6 Titers (IU/mL) | Standard Deviation 1.12 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 4 | 9.0 Titers (IU/mL) | Standard Deviation 0.56 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 5 | 5.9 Titers (IU/mL) | Standard Deviation 0.82 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 6 | 4.8 Titers (IU/mL) | Standard Deviation 0.89 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 7 | 7.8 Titers (IU/mL) | Standard Deviation 0.69 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 8 | 5.8 Titers (IU/mL) | Standard Deviation 0.7 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 9 | 4.5 Titers (IU/mL) | Standard Deviation 0.75 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 10 | 7.7 Titers (IU/mL) | Standard Deviation 0.53 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 11 | 5.1 Titers (IU/mL) | Standard Deviation 0.72 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 12 | 4.2 Titers (IU/mL) | Standard Deviation 0.83 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 13 | 6.3 Titers (IU/mL) | Standard Deviation 0.79 |
| Tdap Vaccine | Anti-tetanus Antibody Titers in Participants Over Time | Month 18 | 5.0 Titers (IU/mL) | Standard Deviation 0 |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 11 | ≥ 5 to 10 IU/mL | 23 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 11 | ≥ 10 to 15 IU/mL | 4 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Screening | < 5 IU/mL | 88 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Screening | ≥ 5 to 10 IU/mL | 8 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Screening | ≥ 10 to 15 IU/mL | 4 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Screening | ≥ 15 IU/mL | 0 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 1 | < 5 IU/mL | 4 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 1 | ≥ 5 to 10 IU/mL | 22 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 1 | ≥ 10 to 15 IU/mL | 12 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 1 | ≥ 15 IU/mL | 36 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 2 | < 5 IU/mL | 14 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 2 | ≥ 5 to 10 IU/mL | 31 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 2 | ≥ 10 to 15 IU/mL | 10 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 2 | ≥ 15 IU/mL | 17 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 3 | < 5 IU/mL | 23 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 3 | ≥ 5 to 10 IU/mL | 29 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 10 | ≥ 10 to 15 IU/mL | 16 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 3 | ≥ 10 to 15 IU/mL | 9 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 3 | ≥ 15 IU/mL | 8 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 4 | < 5 IU/mL | 7 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 4 | ≥ 5 to 10 IU/mL | 30 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 4 | ≥ 10 to 15 IU/mL | 21 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 4 | ≥ 15 IU/mL | 10 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 5 | < 5 IU/mL | 15 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 5 | ≥ 5 to 10 IU/mL | 34 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 5 | ≥ 10 to 15 IU/mL | 12 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 5 | ≥ 15 IU/mL | 3 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 6 | < 5 IU/mL | 20 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 6 | ≥ 5 to 10 IU/mL | 33 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 6 | ≥ 10 to 15 IU/mL | 8 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 6 | ≥ 15 IU/mL | 1 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 7 | < 5 IU/mL | 8 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 7 | ≥ 5 to 10 IU/mL | 29 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 7 | ≥ 10 to 15 IU/mL | 10 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 7 | ≥ 15 IU/mL | 8 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 8 | < 5 IU/mL | 11 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 8 | ≥ 5 to 10 IU/mL | 30 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 8 | ≥ 10 to 15 IU/mL | 9 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 8 | ≥ 15 IU/mL | 1 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 9 | < 5 IU/mL | 20 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 9 | ≥ 5 to 10 IU/mL | 26 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 9 | ≥ 10 to 15 IU/mL | 3 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 9 | ≥ 15 IU/mL | 6 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 10 | < 5 IU/mL | 6 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 10 | ≥ 5 to 10 IU/mL | 21 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 10 | ≥ 15 IU/mL | 1 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 11 | < 5 IU/mL | 15 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 11 | ≥ 15 IU/mL | 0 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 12 | < 5 IU/mL | 13 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 12 | ≥ 5 to 10 IU/mL | 20 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 12 | ≥ 10 to 15 IU/mL | 1 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 12 | ≥ 15 IU/mL | 0 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 13 | < 5 IU/mL | 5 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 13 | ≥ 5 to 10 IU/mL | 27 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 13 | ≥ 10 to 15 IU/mL | 6 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 13 | ≥ 15 IU/mL | 1 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 18 | < 5 IU/mL | 0 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 18 | ≥ 5 to 10 IU/mL | 1 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 18 | ≥ 10 to 15 IU/mL | 0 Participants |
| Tdap Vaccine | Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels | Month 18 | ≥ 15 IU/mL | 0 Participants |