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Vaccine
Tdap Vaccine Safety Study for Plasma Donors
Phase 2
Waitlist Available
Led By Adam Thaler, DO
Research Sponsored by ABO Holdings, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Study Summary
This trial tests safety and response to 5 vaccinations of a Tdap vaccine in healthy plasma donors over one year. Results will indicate if it's safe and what the response is.
Who is the study for?
Healthy adults aged 18-63 who can donate plasma and haven't had a Tdap vaccine in the last 90 days. Women must use effective birth control during the study. Participants cannot be pregnant, have severe reactions to vaccines, or conditions that could affect safety or data quality.Check my eligibility
What is being tested?
The trial tests the safety of giving Tdap vaccinations multiple times over a year to plasma donors. It involves receiving five Tdap shots every three months and monitoring for side effects and tetanus antibody levels.See study design
What are the potential side effects?
Possible side effects include local reactions at the injection site (like pain, redness), body-wide symptoms such as fever, headache, fatigue, gastrointestinal disturbances, allergic reactions or more serious events like Guillain-Barré Syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Anti-tetanus Antibody Titers in Participants Over Time
Number of Participants With Post Vaccination Anti-tetanus Antibody Range Levels
Side effects data
From 2019 Phase 2 trial • 713 Patients • NCT0407115853%
Myalgia
8%
Pyrexia
7%
Injection site swelling
6%
Injection site erythema
2%
Vomiting
1%
Ear infection
1%
Fatigue
1%
Migraine
1%
Haemorrhoids
1%
Injection site pain
1%
Swelling
1%
Pharyngitis streptococcal
1%
Muscle strain
1%
Pharyngeal mass
1%
Axillary pain
1%
Tonsillitis
1%
Depression
1%
Cholecystitis acute
1%
Upper respiratory tract infection
1%
Headache
1%
Toothache
1%
Seasonal allergy
1%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo
RSV Vaccine 120 mcg With Tdap
RSV Vaccine 120 mcg With Placebo
Placebo/Tdap
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tdap for Plasma DonorsExperimental Treatment1 Intervention
Dose: 0.5 mL; Route: Intramuscular (IM) in the deltoid muscle; Frequency: Every 90 days; Duration: 5 doses over 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tdap
2011
Completed Phase 3
~3020
Find a Location
Who is running the clinical trial?
ABO Holdings, Inc.Lead Sponsor
Adam Thaler, DOPrincipal InvestigatorCenter Medical Director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 63 years old.I am using effective birth control and can become pregnant.I haven't received a Tdap vaccine in the last 3 months.I have had Guillain-Barré Syndrome in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Tdap for Plasma Donors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment accept participants over the age of 30?
"As per the guidelines of this trial, only individuals who are over 18 and under 63 years old can be accepted to participate."
Answered by AI
What potential risks do plasma donors face when receiving the Tdap vaccine?
"Our team has rated the safety of Tdap for Plasma Donors a 2, as this is Phase 2 trial and therefore lacks concrete efficacy data but does have some evidence supporting its security."
Answered by AI
Are there any opportunities for volunteers to join this clinical exploration?
"According to clinicaltrials.gov, this study is not currently recruiting participants. Initially posted on March 31st 2023 and last edited December 21st 2022, it appears that recruitment has been temporarily suspended; however, 10 other studies are still open for enrollment at present."
Answered by AI
Who qualifies to partake in this research program?
"This immunization trial is seeking 100 male and female participants aged between 18-63. To be eligible, individuals must provide a signed ICF, practice highly effective birth control measures and not have received Tdap vaccinations in the last three months prior to commencement. Additionally, candidates cannot be part of any other vaccine program."
Answered by AI
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