660 Participants Needed

COVID-19 Booster + Flu Vaccine for Immunocompromised People

(CO2I2 Trial)

RS
Overseen ByRuth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must be taking: Immunosuppressive agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it seems that participants with certain immunocompromising conditions who are on maintenance immunosuppressive treatments are eligible, suggesting you may not need to stop your current meds. It's best to discuss with the trial coordinators for specific guidance.

What data supports the idea that COVID-19 Booster + Flu Vaccine for Immunocompromised People is an effective treatment?

The available research does not provide any data on the effectiveness of the COVID-19 Booster + Flu Vaccine for Immunocompromised People. Instead, the studies focus on treatments for rheumatoid arthritis, comparing different drugs like tocilizumab, abatacept, and others. Therefore, there is no information here to support the effectiveness of the COVID-19 Booster + Flu Vaccine for Immunocompromised People.12345

What safety data exists for COVID-19 and flu vaccines for immunocompromised people?

The safety data for COVID-19 vaccines, including Pfizer-BioNTech, Moderna, and Johnson & Johnson's Janssen, has been extensively studied and reported in various research articles. These studies have analyzed adverse events reported in systems like the Vaccine Adverse Event Reporting System (VAERS) in the United States and similar systems in other countries like Korea. The studies generally show that these vaccines have a well-documented safety profile, with adverse events being monitored and reported since their emergency use authorization. However, specific safety data for the combination of COVID-19 booster and flu vaccines, particularly for immunocompromised individuals, may not be directly addressed in the provided research. It is important for participants to consult with healthcare providers for personalized advice and to consider ongoing clinical trials that may provide more specific safety data for this combination in immunocompromised populations.678910

Is the COVID-19 vaccine a promising treatment for immunocompromised people?

Yes, the COVID-19 vaccine is promising for immunocompromised people. Although their initial response might be weaker, a booster dose can significantly improve their immune response, making the vaccine effective for them.1112131415

What is the purpose of this trial?

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).The main questions it aims to answer are:1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?Researchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.People living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.

Eligibility Criteria

This trial is for people with conditions like HIV, lupus, or rheumatoid arthritis that weaken their immune system. It's also for those who've had an organ transplant. Participants should be due for a COVID-19 booster and flu shot but can't join if they have certain health issues that aren't listed here.

Inclusion Criteria

Have at least one of the following immunocompromising conditions: a) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the specified conditions; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.
I have received at least 3 doses of the mRNA COVID-19 vaccine.

Exclusion Criteria

I cannot receive vaccines by injection due to a bleeding disorder or very low platelet count.
I have not received chemotherapy like cyclophosphamide in the last 6 months.
Received annual vaccination against influenza < 6 months ago
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive COVID-19 and Influenza vaccines with varying schedules to assess immunogenicity and safety

12 months
Visits at baseline, 1, 2, 3, 4, 6, 7, 9, 10, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

  • COVID-19 Vaccines
  • Inactivated influenza vaccine (IIV)
Trial Overview The study tests how well the body responds to different schedules of COVID-19 boosters and flu shots in immunocompromised individuals. It checks if giving both vaccines together works as well as spacing them out, and whether getting COVID-19 boosters every 3 months is better than every 6 months.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment2 Interventions
Covid-19 booster every 6 months and IIV at 1 month
Group II: Group 3Experimental Treatment2 Interventions
Covid-19 booster every 6 months and IIV at baseline
Group III: Group 2Experimental Treatment2 Interventions
Covid-19 booster every 3 months and IIV at 1 month
Group IV: Group 1Experimental Treatment2 Interventions
Covid-19 booster every 3 months and Inactivated influenza vaccine (IIV) at baseline

COVID-19 Vaccines is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Pfizer-BioNTech COVID-19 Vaccine for:
  • Prevention of COVID-19 in individuals 6 months of age and older
🇺🇸
Approved in United States as Moderna COVID-19 Vaccine for:
  • Prevention of COVID-19 in individuals 6 months of age and older
🇺🇸
Approved in United States as Novavax COVID-19 Vaccine for:
  • Prevention of COVID-19 in individuals 12 years of age and older
🇪🇺
Approved in European Union as Comirnaty for:
  • Prevention of COVID-19 in individuals 6 months of age and older
🇪🇺
Approved in European Union as Spikevax for:
  • Prevention of COVID-19 in individuals 6 months of age and older
🇪🇺
Approved in European Union as Nuvaxovid for:
  • Prevention of COVID-19 in individuals 12 years of age and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Findings from Research

In a study of 132 women with active rheumatoid arthritis who did not respond to anti-TNF therapy, both tocilizumab and abatacept significantly reduced disease activity over 24 weeks, as measured by the DAS28-ESR score.
While both treatments were effective, abatacept demonstrated a better safety profile, with fewer adverse effects and more favorable laboratory results compared to tocilizumab, which was associated with declines in hemoglobin and neutrophil counts, as well as increases in blood pressure and liver enzymes.
Efficacy and safety profile of intravenous tocilizumab versus intravenous abatacept in treating female Saudi Arabian patients with active moderate-to-severe rheumatoid arthritis.Elmedany, SH., Mohamed, AE., Galil, SMA.[2020]
In the AVERT-2 study, 22% of patients treated with abatacept plus methotrexate achieved remission at week 24, and a significant proportion (56% for SDAI remission) maintained this response through week 52, indicating the efficacy of this combination therapy in early rheumatoid arthritis.
Patients who continued on weekly abatacept treatment during the de-escalation period had higher rates of sustained remission compared to those who de-escalated or withdrew abatacept, suggesting that ongoing treatment may be beneficial for maintaining remission.
The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study.Emery, P., Tanaka, Y., Bykerk, VP., et al.[2023]
Tocilizumab, either alone or in combination with methotrexate, showed superior effectiveness in treating rheumatoid arthritis compared to standard care and methotrexate alone, with significant improvements in ACR response rates at 26 weeks based on a network meta-analysis of 68 randomized controlled trials involving 207 articles.
The study found that tocilizumab's effectiveness was comparable to other biologics, indicating it is a viable treatment option for patients with rheumatoid arthritis who have not responded to conventional therapies.
Comparative effectiveness of biologics for the management of rheumatoid arthritis: systematic review and network meta-analysis.Alfonso-Cristancho, R., Armstrong, N., Arjunji, R., et al.[2021]

References

Efficacy and safety profile of intravenous tocilizumab versus intravenous abatacept in treating female Saudi Arabian patients with active moderate-to-severe rheumatoid arthritis. [2020]
The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study. [2023]
Comparative effectiveness of biologics for the management of rheumatoid arthritis: systematic review and network meta-analysis. [2021]
Targeting lymphocyte activation to treat rheumatoid arthritis. [2020]
Compared efficacy of rituximab, abatacept, and tocilizumab in patients with rheumatoid arthritis refractory to methotrexate or TNF inhibitors agents: a systematic review and network meta-analysis. [2023]
Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. [2022]
The safety profile of COVID-19 vaccinations in the United States. [2021]
COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021. [2021]
The COVID-19 Vaccines: A Description of Adverse Events of Reactions Reported in Kansas. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A comprehensive review of SARS-CoV-2 vaccines: Pfizer, Moderna & Johnson & Johnson. [2023]
COVID-19 vaccine use in immunocompromised patients: A commentary on evidence and recommendations. [2022]
Administration of COVID-19 vaccines in immunocompromised patients. [2022]
Serological Response in Lung Transplant Recipients after Two Doses of SARS-CoV-2 mRNA Vaccines. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
mRNA COVID-19 vaccine booster fosters B- and T-cell responses in immunocompromised patients. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial. [2022]
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