Trial Outcomes & Findings for Tdap Vaccine Safety for Plasma Donors (NCT NCT04142983)
NCT ID: NCT04142983
Last Updated: 2022-12-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
110 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2022-12-06
Participant Flow
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
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.
Participant milestones
| Measure |
Tdap Vaccine
The vaccine was administered every 3 months ± 1 week for 12 months (5 vaccinations)
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
Treatment Population
|
100
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
99
|
Reasons for withdrawal
| Measure |
Tdap Vaccine
The vaccine was administered every 3 months ± 1 week for 12 months (5 vaccinations)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
73
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
No longer eligible
|
4
|
|
Overall Study
Screen Failure
|
10
|
Baseline Characteristics
Tdap Vaccine Safety for Plasma Donors
Baseline characteristics by cohort
| Measure |
Tdap Vaccine
n=100 Participants
The vaccine was administered every 3 months ± 1 week for 12 months (5 vaccinations)
|
|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 9.17 • n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Population included all enrolled participants who received at least one vaccination and had safety data.
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.
Outcome measures
| Measure |
Tdap Vaccine
n=100 Participants
Tdap vaccine 0.5 mL administered intramuscularly on Day 0, Month 3, Month 6, Month 9 and Month 12.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with at least one TEAE
|
71 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with at least one TEAE related to the study product
|
42 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with at least one serious TEAE
|
0 participants
|
SECONDARY outcome
Timeframe: 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 18Population: 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.
Anti-tetanus antibody titer levels after each vaccination presented at geometric means (GeoMean) over time.
Outcome measures
| Measure |
Tdap Vaccine
n=100 Participants
Tdap vaccine 0.5 mL administered intramuscularly on Day 0, Month 3, Month 6, Month 9 and Month 12.
|
|---|---|
|
Anti-tetanus Antibody Titers in Participants Over Time
Screening
|
1.2 Titers (IU/mL)
Standard Deviation 1.29
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 1
|
13.2 Titers (IU/mL)
Standard Deviation 0.74
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 2
|
8.1 Titers (IU/mL)
Standard Deviation 0.89
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 3
|
5.6 Titers (IU/mL)
Standard Deviation 1.12
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 4
|
9.0 Titers (IU/mL)
Standard Deviation 0.56
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 5
|
5.9 Titers (IU/mL)
Standard Deviation 0.82
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 6
|
4.8 Titers (IU/mL)
Standard Deviation 0.89
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 7
|
7.8 Titers (IU/mL)
Standard Deviation 0.69
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 8
|
5.8 Titers (IU/mL)
Standard Deviation 0.70
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 9
|
4.5 Titers (IU/mL)
Standard Deviation 0.75
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 10
|
7.7 Titers (IU/mL)
Standard Deviation 0.53
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 11
|
5.1 Titers (IU/mL)
Standard Deviation 0.72
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 12
|
4.2 Titers (IU/mL)
Standard Deviation 0.83
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 13
|
6.3 Titers (IU/mL)
Standard Deviation 0.79
|
|
Anti-tetanus Antibody Titers in Participants Over Time
Month 18
|
5.0 Titers (IU/mL)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 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 18Population: 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.
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.
Outcome measures
| Measure |
Tdap Vaccine
n=100 Participants
Tdap vaccine 0.5 mL administered intramuscularly on Day 0, Month 3, Month 6, Month 9 and Month 12.
|
|---|---|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 12 · ≥ 5 to 10 IU/mL
|
20 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Screening · < 5 IU/mL
|
88 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Screening · ≥ 5 to 10 IU/mL
|
8 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Screening · ≥ 10 to 15 IU/mL
|
4 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Screening · ≥ 15 IU/mL
|
0 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 1 · < 5 IU/mL
|
4 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 1 · ≥ 5 to 10 IU/mL
|
22 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 1 · ≥ 10 to 15 IU/mL
|
12 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 1 · ≥ 15 IU/mL
|
36 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 2 · < 5 IU/mL
|
14 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 2 · ≥ 5 to 10 IU/mL
|
31 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 2 · ≥ 10 to 15 IU/mL
|
10 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 2 · ≥ 15 IU/mL
|
17 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 3 · < 5 IU/mL
|
23 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 3 · ≥ 5 to 10 IU/mL
|
29 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 3 · ≥ 10 to 15 IU/mL
|
9 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 3 · ≥ 15 IU/mL
|
8 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 4 · < 5 IU/mL
|
7 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 4 · ≥ 5 to 10 IU/mL
|
30 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 4 · ≥ 10 to 15 IU/mL
|
21 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 4 · ≥ 15 IU/mL
|
10 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 5 · < 5 IU/mL
|
15 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 5 · ≥ 5 to 10 IU/mL
|
34 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 5 · ≥ 10 to 15 IU/mL
|
12 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 5 · ≥ 15 IU/mL
|
3 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 6 · < 5 IU/mL
|
20 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 6 · ≥ 5 to 10 IU/mL
|
33 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 6 · ≥ 10 to 15 IU/mL
|
8 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 6 · ≥ 15 IU/mL
|
1 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 7 · < 5 IU/mL
|
8 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 7 · ≥ 5 to 10 IU/mL
|
29 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 7 · ≥ 10 to 15 IU/mL
|
10 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 7 · ≥ 15 IU/mL
|
8 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 8 · < 5 IU/mL
|
11 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 8 · ≥ 5 to 10 IU/mL
|
30 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 8 · ≥ 10 to 15 IU/mL
|
9 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 8 · ≥ 15 IU/mL
|
1 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 9 · < 5 IU/mL
|
20 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 9 · ≥ 5 to 10 IU/mL
|
26 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 9 · ≥ 10 to 15 IU/mL
|
3 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 9 · ≥ 15 IU/mL
|
6 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 10 · < 5 IU/mL
|
6 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 10 · ≥ 5 to 10 IU/mL
|
21 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 10 · ≥ 10 to 15 IU/mL
|
16 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 10 · ≥ 15 IU/mL
|
1 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 11 · < 5 IU/mL
|
15 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 11 · ≥ 5 to 10 IU/mL
|
23 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 11 · ≥ 10 to 15 IU/mL
|
4 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 11 · ≥ 15 IU/mL
|
0 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 12 · < 5 IU/mL
|
13 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 12 · ≥ 10 to 15 IU/mL
|
1 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 12 · ≥ 15 IU/mL
|
0 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 13 · < 5 IU/mL
|
5 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 13 · ≥ 5 to 10 IU/mL
|
27 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 13 · ≥ 10 to 15 IU/mL
|
6 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 13 · ≥ 15 IU/mL
|
1 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 18 · < 5 IU/mL
|
0 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 18 · ≥ 5 to 10 IU/mL
|
1 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 18 · ≥ 10 to 15 IU/mL
|
0 Participants
|
|
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Month 18 · ≥ 15 IU/mL
|
0 Participants
|
Adverse Events
Tdap Vaccine
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tdap Vaccine
n=100 participants at risk
Tdap vaccine 0.5 mL administered intramuscularly on Day 0, Month 3, Month 6, Month 9 and Month 12.
|
|---|---|
|
General disorders
Injection site pain
|
37.0%
37/100 • 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.
|
|
General disorders
Injection site bruising
|
26.0%
26/100 • 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.
|
|
General disorders
Injection site erythema
|
14.0%
14/100 • 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.
|
|
General disorders
Injection site induration
|
8.0%
8/100 • 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.
|
|
General disorders
Injection site swelling
|
6.0%
6/100 • 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.
|
|
Investigations
Red blood cells urine positive
|
18.0%
18/100 • 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.
|
|
Investigations
Urine leukocyte esterase positive
|
17.0%
17/100 • 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.
|
|
Investigations
Protein urine present
|
14.0%
14/100 • 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.
|
|
Investigations
Hemoglobin urine present
|
11.0%
11/100 • 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.
|
|
Investigations
Glucose urine present
|
7.0%
7/100 • 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.
|
|
Investigations
Urine ketone body present
|
5.0%
5/100 • 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.
|
|
Nervous system disorders
Headache
|
5.0%
5/100 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place