COVID-19 Booster + Flu Vaccine for Immunocompromised People
(CO2I2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must be taking: Immunosuppressive agents
Must not be taking: Intravenous immunoglobulins, Chemotherapy
Disqualifiers: Recent vaccines, Guillain-Barre, others
No Placebo Group
Prior Safety Data
Approved in 6 jurisdictions
Trial Summary
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.
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.
12345What 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.
678910Is 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.
1112131415Eligibility 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
I am 18 years old or older.
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
+6 more
Trial 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
Participant Groups
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.
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, United States, United States, European Union, European Union, 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
Research Locations NearbySelect from list below to view details:
Research Institute of McGill University Health CentreMontréal, Canada
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Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
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]To compare the efficacy and safety of tocilizumab with those of abatacept in patients with active rheumatoid arthritis not responding to anti-tumor necrosis factor therapy.
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]AVERT-2 (a phase IIIb, two-stage study) evaluated abatacept + methotrexate versus methotrexate alone, in methotrexate-naive, anti-citrullinated protein antibody-positive patients with early (≤ 6 months), active RA. This subanalysis investigated whether individual patients who achieved the week 24 Simplified Disease Activity Index (SDAI) remission primary endpoint could sustain remission to 1 year and then maintain it following changes in therapy.
Comparative effectiveness of biologics for the management of rheumatoid arthritis: systematic review and network meta-analysis. [2021]Our aim was to establish the comparative effectiveness of rheumatoid arthritis (RA) biologics, using a systematic review and network meta-analysis. The systematic review used randomized controlled trials (RCTs) in adults with RA who failed treatment with conventional disease-modifying agents for rheumatoid disease (cDMARDs). We compared the effectiveness of abatacept, adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and rituximab to tocilizumab, a recent biologic with a different mechanism of action (anti-IL-6 receptor). A network meta-analysis (NMA) included the indirect and direct evidence previously selected. In total, 207 articles were included describing 68 RCTs. The NMA showed that tocilizumab monotherapy was superior to standard care (ACR20, OR 13.27, 95 % CrI [3.958, 43.98]; ACR50, 17.45 [10.18, 31.24]; ACR70, 37.77 [7.226, 216.3]; EULAR, 10.42 [1.963, 54.8]); and methotrexate (MTX; ACR50, OR 5.44 [4.142, 7.238]; ACR70, 7.364 [1.4, 30.83]; EULAR, 4.226 [1.184, 15.58]) at 26 weeks. Similarly, the combination of tocilizumab + MTX was significantly better than standard care/placebo and MTX alone for ACR20, ACR50, ACR70, and EULAR at 26 weeks (OR 18.63 [5.32, 66.81]; 24.27 [14.5, 41.91]; 46.13 [10.08, 277]; 14.23 [2.493, 84.02]; 4.169 [2.267, 7.871]; 5.44 [4.142, 7.238]; 8.731 [4.203, 19.29]; 7.306 [4.393, 13.04], respectively). At 52 weeks, compared to MTX alone, tocilizumab + MTX was significantly better for ACR20 and ACR50 response. Few significant differences were found between tocilizumab (alone or in combination) and any other biologics. Results must be considered in context with the limitations of the available evidence. This NMA suggests that tocilizumab was superior to cDMARDs and as effective as other biologics for RA.
Targeting lymphocyte activation to treat rheumatoid arthritis. [2020]The introduction of targeted treatments has radically changed the management of patients with rheumatoid arthritis (RA). Abatacept is among these new treatments emerging from recent insights into joint immunopathology. Abatacept blocks the interaction between antigen-presenting cells and T-cells, thereby diminishing T-cell activation and possibly improving overall cell regulation. In RA patients, abatacept is effective in decreasing the arthritis, pain, disability, fatigue, and radiological joint damage. Abatacept provides lasting remissions or low levels of disease activity and therefore constitutes a valuable addition to the current therapeutic armamentarium for RA, which is hoped to make a full remission an attainable goal in the overall population of RA patients.
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]Our aim was to compare the efficacy of rituximab, tocilizumab, and abatacept in individuals with rheumatoid arthritis (RA) refractory to treatments with MTX or TNFi agents.
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]This study assessed and compared the frequency and type of adverse events (AEs) of the Pfizer-BioNTech, Moderna, and Janssen coronavirus disease 2019 (COVID-19) vaccines reported in the Vaccine Adverse Event Reporting System (VAERS).
The safety profile of COVID-19 vaccinations in the United States. [2021]Pfizer-BioNTech, Moderna, and Johnson & Johnson's Janssen are the 3 COVID-19 vaccines authorized for emergency use in the United States. This study aims to analyze and compare adverse events following immunization associated with these COVID-19 vaccines based on Vaccine Adverse Effect Reporting System data.
COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021. [2021]On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
The COVID-19 Vaccines: A Description of Adverse Events of Reactions Reported in Kansas. [2022]Coronavirus disease 2019 (COVID-19) is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and has spread rapidly throughout the world since its discovery in 2019. Three vaccines (Pfizer-BioNTech, Moderna/NIAID/BARDA, and Johnson & Johnson's Janssen) have been developed for use in the U.S. to aid in the fight against this virus, but have been scrutinized intensely for their efficacy and safety. It is important to understand and interpret the adverse events or reactions (AERs) associated with these vaccines in an objective and analytical manner. The goal of this descriptive study was to provide a resource outlining AERs associated with the three available vaccines in Kansas.
A comprehensive review of SARS-CoV-2 vaccines: Pfizer, Moderna & Johnson & Johnson. [2023]The novel coronavirus outbreak was declared a pandemic in March 2020. We are reviewing the COVID-19 vaccines authorized for use in the United States by discussing the mechanisms of action, administration, side effects, and efficacy of vaccines developed by Pfizer, Moderna, and Johnson & Johnson. Pfizer and Moderna developed mRNA vaccines, encoding the spike protein of SARS-CoV-2, whereas Johnson & Johnson developed an adenovirus vector-based vaccine. Safety has been shown in a large cohort of participants in clinical trials as well as the general population since emergency approval of vaccine administration in the US. Clinical trial results showed the Pfizer and Moderna vaccines to be 95.0%, and the Johnson & Johnson vaccine to be 66.0% effective in protecting against moderate and symptomatic SARS-CoV-2 infection. It is important to keep medical literature updated with the ongoing trials of these vaccinations, especially as they are tested among different age groups and upon the emergence of novel variants of the SARS-CoV-2 coronavirus.
COVID-19 vaccine use in immunocompromised patients: A commentary on evidence and recommendations. [2022]While COVID-19 vaccine emergency use authorization (EUA) deemed the vaccines to be effective and safe for public use, the phase 3 trials leading to EUA predominantly excluded patients with immunocompromising conditions. Immunocompromised patients make up a significant proportion of the population, and in light of recent mass vaccination efforts, we aim to review current evidence and recommendations of COVID-19 vaccines in 4 patient populations with immunocompromising disorders or conditions: human immunodeficiency virus (HIV) infection, solid organ transplantation, rheumatoid arthritis, and inflammatory bowel disease.
Administration of COVID-19 vaccines in immunocompromised patients. [2022]Since the beginning of vaccination programs against COVID-19 in different countries, several populations such as patients with specific immunological conditions have been considered as the priorities for immunization. In this regard, patients with autoimmune diseases or those receiving immunosuppressive agents and anti-cancer therapies, need special attention. However, no confirmed data is presently available regarding COVID-19 vaccines in these populations due to exclusion from the conducted clinical trials. Given the probable suppression or over-activation of the immune system in such patients, reaching a consensus for their vaccination is critical, besides gathering data and conducting trials, which could probably clarify this matter in the future. In this review, besides a brief on the available COVID-19 vaccines, considerations and available knowledge about administering similar vaccines in patients with cancer, hematopoietic stem cell transplantation, solid organ transplantation, multiple sclerosis (MS), inflammatory bowel disease (IBD), and rheumatologic and dermatologic autoimmune disorders are summarized to help in decision making. As discussed, live-attenuated viruses, which should be avoided in these groups, are not employed in the present COVID-19 vaccines. Thus, the main concern regarding efficacy could be met using a potent COVID-19 vaccine. Moreover, the vaccination timing for maximum efficacy could be decided according to the patient's condition, indicated medications, and the guides provided here. Post-vaccination monitoring is also advised to ensure an adequate immune response. Further studies in this area are urgently warranted.
Serological Response in Lung Transplant Recipients after Two Doses of SARS-CoV-2 mRNA Vaccines. [2021]Lung-transplant (LT) recipients are at high risk for COVID-19 due to immunosuppression and respiratory tropism of SARS-CoV-2. The information on the effect of COVID-19 mRNA vaccines to elicit immunogenic responses after a two-dose (2D) regimen in LT recipients is sparse. Thus, we assessed the effect of Pfizer-BioNTech and Moderna mRNA vaccines' 2D regimen on anti-spike responses in immunocompromised LT recipients.
mRNA COVID-19 vaccine booster fosters B- and T-cell responses in immunocompromised patients. [2022]SARS-CoV-2 vaccination has proven effective in inducing an immune response in healthy individuals and is progressively us allowing to overcome the pandemic. Recent evidence has shown that response to vaccination in some vulnerable patients may be diminished, and it has been proposed a booster dose. We tested the kinetic of development of serum antibodies to the SARS-CoV-2 Spike protein, their neutralizing capacity, the CD4 and CD8 IFN-γ T-cell response in 328 subjects, including 131 immunocompromised individuals (cancer, rheumatologic, and hemodialysis patients), 160 health-care workers (HCW) and 37 subjects older than 75 yr, after vaccination with two or three doses of mRNA vaccines. We stratified the patients according to the type of treatment. We found that immunocompromised patients, depending on the type of treatment, poorly respond to SARS-CoV-2 mRNA vaccines. However, an additional booster dose of vaccine induced a good immune response in almost all of the patients except those receiving anti-CD20 antibody. Similarly to HCW, previously infected and vaccinated immunocompromised individuals demonstrate a stronger SARS-CoV-2-specific immune response than those who are vaccinated without prior infection.
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]BNT162b2 by Pfizer-BioNTech and mRNA-1273 by Moderna are the most commonly used vaccines to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Head-to-head comparison of the efficacy of these vaccines in immunocompromised patients is lacking.