IDCRP-154: Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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 2025 CIRV2 will compare immunogenicity and reactogenicity of the recombinant Novavax COVID-19 vaccine and the mRNA Pfizer-BioNTech COVID-19 vaccine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: t
View:

• 18-79 years old

• Have a history of any of the following risk factors for severe COVID:

‣ Asthma

⁃ 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

⁃ Current or prior smoker

⁃ 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%

⁃ Obesity with BMI ≥ 30 and \< 40

⁃ 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 and be able to follow-up online for the next 9 months.

Locations
United States
Maryland
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Contact Information
Primary
Marianne Spevak, BSHS
mspevak@hjf.org
240-694-2067
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2027-09
Participants
Target number of participants: 54
Treatments
Active_comparator: For fall of 2025, 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
Active_comparator: For fall of 2025, Arm 2 of the study will be the Novavax recombinant protein vaccine
Arm 2 of the study will be the Novavax recombinant protein vaccine
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention, U.S. Food and Drug Administration (FDA)
Leads: Henry M. Jackson Foundation for the Advancement of Military Medicine

This content was sourced from clinicaltrials.gov