IDCRP-154: Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Variant-specific immune responses
研究概览
简要总结
CIRV2 is a Phase IV randomized, open-label, trial of FDA-approved COVID-19 and/or influenza vaccines (no more than minimal risk) with longitudinal follow-up. In 2026 CIRV2 will compare immunogenicity and reactogenicity of the recombinant Novavax COVID-19 vaccine and the mRNA Pfizer-BioNTech COVID-19 vaccine.
详细描述
The goal of the Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) study is to conduct, on a yearly basis, direct comparisons of immunogenicity and reactogenicity of the most recent versions of FDA-approved vaccines for COVID-19 and/or influenza. Studies will be conducted on individuals that are FDA eligible to receive these vaccines and do not have a medical condition that severely impairs their immune system. For 2026, the study will directly compare the immunogenicity and reactogenicity of the 2026 Novavax recombinant COVID-19 vaccine with the 2026 Pfizer/BioNTech mRNA COVID-19 vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open-label, with concealment of vaccine allocation until time of vaccination and blinding of all laboratory personnel conducting antibody assays.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-79 years old
- •Have a history of any of the following risk factors for severe COVID:
- •Age > 65 years old
- •Physical inactivity (defined as <150 mins of moderate activity per week or <75 mins of vigorous activity per week)
- •HIV with CD4 count ≥ 500 cells/ul
- •Obesity with BMI ≥ 30 and < 40
- •History of:
- •Depression or other mood disorder
- •Schizophrenia spectrum disorder
- •Cerebrovascular disease
- •Heart failure
- •Coronary artery disease
- •Cardiomyopathy
- •Pulmonary embolism
- •Pulmonary hypertension
- •Cystic fibrosis
- •Bronchiectasis
- •Chronic obstructive pulmonary disease
- •Interstitial Lung Disease
- •Stage I or II chronic kidney disease (Stage 1 defined as normal GFR (> 90) but with other signs of kidney damage such as proteinuria or hematuria) (Stage 2 defined as having a glomerular filtration rate (GFR) of 60 - 89 ml/min/1.73m2)
- •Gestational diabetes
- •Type 1 diabetes with most recent HgbA1C < 7.5%
- •Type 2 diabetes with most recent HgbA1C < 7.5%
- •Liver disease without cirrhosis and with liver enzyme levels (AST and ALT) no greater than three times the upper limit of normal
- •Military Health System beneficiary and DEERS eligible
- •Willing to be randomized to receive either the Novavax COVID-19 vaccine or the mRNA Pfizer-BioNTech COVID-19 vaccine
- •Will be able to return for a clinic visit in approximately 30 days, Day 150, and be able to follow-up online for the next 9 months.
排除标准
- •History of severe allergy or severe adverse reaction such as myocardial inflammation to any component of the mRNA COVID-19 vaccines or the Novavax recombinant COVID-19 vaccine
- •Received a COVID-19 vaccine in the last 3 months.
- •Tested positive for COVID-19 in the past 3 months.
- •- Presence of fever, cough, chills, shortness of breath, runny nose, or sore throat today on day of screening/enrollment visit.
- •Active use of immune modulating medications.
- •- Defined as active use of chronic immune modulating medications such as systemic corticosteroids at a dose equivalence of 20 mg prednisone or greater daily for over one month, chemotherapy, cytokine inhibitors, or agents that reduce T cell or B cell numbers or function.
- •Diagnosed with immunocompromised stated.
- •- Defined as: presence of a disease that is actively causing severe immune suppression or history of prior splenectomy (removal of spleen).
- •Diabetes with the most recent HgbA1C ≥ 7.
- •Stage III or greater chronic kidney disease
- •- Defined as estimated glomerular filtration rate < 60 ml/min/1.73m2)
- •Obesity with a BMI ≥ 40
- •HIV with a CD4 cell count < 500 cells/ul
- •History of solid organ or bone marrow transplant.
- •Active malignancy
- •- Defined as any cancer that is currently being treated or has shown evidence of progression within the past year.
- •Chronic liver disease with compensated or decompensated cirrhosis, or liver enzyme levels (AST or ALT) greater than three times the upper limit of normal.
研究组 & 干预措施
For fall of 2026, Arm 1 of the study will be the Pfizer-BioNTech mRNA COVID-19 vac
Arm 1 of the study will be Pfizer-BioNTech mRNA COVID-19 vaccine
干预措施: Pfizer-BioNTech mRNA COVID-19 vaccine (Drug)
For fall of 2026, Arm 2 of the study will be the Novavax recombinant protein vaccine
Arm 2 of the study will be the Novavax recombinant protein vaccine
干预措施: Novavax recombinant protein vaccine (Drug)
结局指标
主要结局
Variant-specific immune responses
时间窗: IgG binding antibody levels and neutralizing antibody titers will be assessed on serum samples obtained just prior to vaccination, 30 days (+/- 10 days), and 150 days (+/- 10 days) after vaccination.
The primary endpoint is variant-specific immune response (magnitude and breadth) to licensed recombinant and mRNA COVID-19 products administered to adult MHS beneficiaries who are eligible for a fall COVID-19 vaccine and who are not severely immunocompromised. This will include quantifying the magnitude of binding and neutralizing antibodies to the vaccine variants and to the dominant variant present 30 days and 150 days post-vaccination. Specifically, we will test neutralizing titers (defined as the inverse serum dilution causing a 50% reduction in relative light units in a pseudovirus neutralization assay) and IgG binding antibody levels (measured in arbitrary units) against the following SARS-CoV-2 variants: XFG (vaccine strain), Wuhan-1 (ancestral strain), plus the dominant circulating variant(s) circulating during the fall of 2026 and winter of 2026-2027.
Variant-specific immune responses
时间窗: IgG binding antibody levels and neutralizing antibody titers will be assessed on serum samples obtained just prior to vaccination and 30 days (+/- 10 days) after vaccination.
The primary endpoint is variant-specific immune response (magnitude and breadth) to licensed recombinant and mRNA COVID-19 products administered to healthy adult MHS beneficiaries. This will include quantifying the magnitude of binding and neutralizing antibodies to the vaccine variants and to the dominant variant present one month post-vaccination. Specifically, we will test neutralizing titers (defined as the inverse serum dilution causing a 50% reduction in relative light units in a pseudovirus neutralization assay) and IgG binding antibody levels (measured in arbitrary units) against the following SARS-CoV-2 variants: NB.1.8.1 and XFG (predominant circulating strains in fall 2025), JN.1 and LP.8.1 (vaccine strains), and Wuhan-1 (ancestral strain).
次要结局
未报告次要终点