HealthyPhase 1NCT02673255
Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program
A Phase 1 study testing Tetanus and Diphtheria (Td) Vaccine in people with Healthy, run by Biomat USA, Inc. at 4 sites in United States.
Trial summary
Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tetanus and Diphtheria (Td) Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Aug 2016to 29 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥18* years of age at Visit 1.
- Subject has met all suitability criteria that would allow donation as a Normal Source Plasma donor
- Subject has not been immunized for tetanus within the prior three (3) months
- Subject is not participating in any other immunization program
- Subject possesses a pre-existing antibody for tetanus of at least 0.15 IU/mL
Who cannot join
- Pregnant.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Subject has a 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
- Subject is unable to read and/or write due to illiteracy or a physical impairment.
- The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for adverse event assessment
- Or legal adult according to local law. Participants in NE limited to individuals age 19-69 years due to age of majority laws in NE.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Biomat Bellflower
Bellflower, California, 90706
Biomat Clarksville
Clarksville, Tennessee, 37042
Biomat Lincoln
Lincoln, Nebraska, 68510
Biomat Salt Lake City 1
Salt Lake City, Utah, 84116
About this study
Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease.
The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.
Read more
In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac).
The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days.
The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.
- Conditions
- Healthy
- Being tested
- Tetanus and Diphtheria (Td) Vaccine
- Keywords
- Plasma, Plasma Donor, Plasma Donation, Tetanus, Td, Immunoglobulin, Hyper-immunization
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus and Diphtheria (Td) VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Sanofi Pasteur (Tenivac) | Experimental | Tetanus and Diphtheria (Td) Vaccine, Manufacturer: Sanofi Pasteur (Tenivac), Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year. Receives: Biological: Tetanus and Diphtheria (Td) Vaccine |
| MassBiologics | Experimental | Tetanus and Diphtheria (Td) Vaccine, Manufacturer: MassBiologics, Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year. Receives: Biological: Tetanus and Diphtheria (Td) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a positive tetanus titer response following immunization
A "positive response" is defined as a 4-fold increase if the pre-vaccination titer was less than or equal to 2.7IU/mL or a 2-fold increase if the pre-vaccination titer was greater than 2.7IU/mL
Measured: Through study completion, average 18 months.
Secondary outcomes (1)
Number of participants experiencing vaccine-related adverse events
Number of related adverse events will be compared with prescribing information for the vaccine and with historic data on adverse event rates among Normal Source plasma donors and Hyper-Immunized plasma donors. Severity grading of vaccine-related adverse events is based on a modified version of FDA guidance dated September 2007 titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."
Measured: Through study completion, average 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start22 Aug 2016
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomat USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammond Clinical Trial Consulting, LLC, Axio Research. LLC
- Responsible party
- Sponsor
- Investigators
- Marilyn Rosa-Bray, MD, Principal investigator, Biomat USA, Inc. (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673255
- Sponsor's protocol ID
- GB-0115
- Status last verified
- Dec 2019
- First submitted
- 29 Jan 2016
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program
- ClinicalTrials.gov ID
- NCT02673255
- Acronym / sponsor ID
- GB-0115
- Conditions
- Healthy
- Keywords
- Plasma, Plasma Donor, Plasma Donation, Tetanus, Td, Immunoglobulin, Hyper-immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Biomat USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hammond Clinical Trial Consulting, LLC, Axio Research. LLC
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease.
The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.
In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac).
The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days.
The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanofi Pasteur (Tenivac) | Experimental | Biological: Tetanus and Diphtheria (Td) VaccineTetanus and Diphtheria (Td) Vaccine, Manufacturer: Sanofi Pasteur (Tenivac), Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year. |
| MassBiologics | Experimental | Biological: Tetanus and Diphtheria (Td) VaccineTetanus and Diphtheria (Td) Vaccine, Manufacturer: MassBiologics, Dose: 0.5 mL, Route: Intramuscular (IM) in the deltoid muscle, Frequency: Every 90 days, Duration: 5 doses, 1 year. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18* years of age at Visit 1.
- Subject has met all suitability criteria that would allow donation as a Normal Source Plasma donor
- Subject has not been immunized for tetanus within the prior three (3) months
- Subject is not participating in any other immunization program
- Subject possesses a pre-existing antibody for tetanus of at least 0.15 IU/mL
Key exclusion criteria (8 listed)
- Pregnant.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Subject has a 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus and Diphtheria (Td) Vaccine | Biological | MassBiologics, Sanofi Pasteur (Tenivac) |
Primary outcome
Percentage of participants with a positive tetanus titer response following immunization
Time frame: Through study completion, average 18 months.
A "positive response" is defined as a 4-fold increase if the pre-vaccination titer was less than or equal to 2.7IU/mL or a 2-fold increase if the pre-vaccination titer was greater than 2.7IU/mL
1 secondary outcome
Number of participants experiencing vaccine-related adverse events
Time frame: Through study completion, average 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Rosa-Bray, MD principal investigator
Biomat USA, Inc. (Sponsor)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetanus and Diphtheria (Td) Vaccine in people with Healthy, run by Biomat USA, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with a positive tetanus titer response following immunization (time frame: Through study completion, average 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.