COVID 19 study: COVID-19 Vaccines at a
Official title COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
ClinicalTrials.gov ID: NCT06599658
What this study is testing
What is Inactivated influenza vaccine (IIV) at baseline?
An investigational vaccine being studied to see if it can be given at the same time as a COVID‑19 booster to improve immune responses in people with immunocompromising conditions.
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
- The study wants to see whether co‑administering a seasonal flu shot with a COVID‑19 booster gives a similar short‑term immune response as giving them one month apart, and whether giving COVID boosters every 3 months keeps immunity stronger than every 6 months.
- Who it's for
- It is looking for adults who have conditions that weaken their immune system, such as rheumatoid arthritis, lupus, inflammatory bowel disease, solid organ transplant, or HIV.
- What's involved
- Participants will receive COVID‑19 and flu vaccines according to one of four schedules, have blood drawn to measure immune response, and fill out questionnaires about side effects and quality of life. They will also be monitored for health changes.
- Time commitment
- The study lasts about 12 months, with visits for vaccination, blood draws, and questionnaires at the start, 1–2 months, 3–6 months, and 12 months after the first COVID booster.
- Phase 2: a mid-size study of how well it works
- 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
- a) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen
You likely can't join if
- Annual vaccination against influenza \< 6 months ago
- COVID-19 booster \
- life-threatening reaction any component of the IIV or COVID-19 vaccines
- Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination
- Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.