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New treatment option for COVID-19
Official title Immunosuppression and COVID-19 Boosters
ClinicalTrials.gov ID: NCT05415267
What this study is testing
What is diphtheria and tetanus toxoids (adsorbed) vaccine?
diphtheria and tetanus toxoids (adsorbed) vaccine is an investigational medicine, being studied as a potential treatment for covid-19.
Also referred to as ADT Booster.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult aged at least 18 years
- Previously vaccinated with 2 (or more) doses of any licensed COVID-19 vaccine who requires initiation of moderate-to-severe immunosuppression; most...
- Planned significant immunosuppressive therapy for at least 1 year
- No cyclophosphamide, alemtuzumab or rituximab treatment in the past 5 years. Note: patient may have concurrent steroids with any treatments listed in...
- Voluntarily given written informed consent
You likely can't join if
- Pregnant or breastfeeding
- Has underlying primary immunodeficiency
- Has received or likely to receive intravenous/subcutaneous immunoglobulin (IVIg/ScIg).
- Projected treatment is likely to involve plasma exchange
- Contraindication to receipt of SARS-CoV-2 vaccine
- Intolerance of or previous allergic reaction to tetanus vaccination
See the full eligibility criteria
- Adult aged at least 18 years
- Previously vaccinated with 2 (or more) doses of any licensed COVID-19 vaccine who requires initiation of moderate-to-severe immunosuppression; most recent COVID-19 vaccine dose must have been given \> 3 months prior
- Planned significant immunosuppressive therapy for at least 1 year
- No cyclophosphamide, alemtuzumab or rituximab treatment in the past 5 years. Note: patient may have concurrent steroids with any treatments listed in protocol
- Voluntarily given written informed consent
- Pregnant or breastfeeding
- Has underlying primary immunodeficiency
- Has received or likely to receive intravenous/subcutaneous immunoglobulin (IVIg/ScIg).
- Projected treatment is likely to involve plasma exchange
- Contraindication to receipt of SARS-CoV-2 vaccine
- Intolerance of or previous allergic reaction to tetanus vaccination
- Patients switching immunosuppressive therapies following enrolment with an absolute lymphocyte count \<0.5 x 109/L immediately prior to screening
The study team makes the final eligibility decision.
Where it's taking place
- Blacktown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Concord, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- Westmead, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blacktown, New South Wales, Australia; Camperdown, New South Wales, Australia; Concord, New South Wales, Australia; Darlinghurst, New South Wales, Australia; Westmead, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.