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New treatment option for COVID-19
Official title A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
ClinicalTrials.gov ID: NCT06810934
What this study is testing
What is CoTend-BXBB (SARS2-30404)?
CoTend-BXBB (SARS2-30404) is an investigational medicine, being studied as a potential treatment for covid-19.
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 goal of this clinical trial is to test two investigational COVID-19 booster vaccines, called CoTend-s3BXBB and CoTend-BXBB, in healthy volunteers ages 40-64. The CoTend-s3BXBB vaccine includes a component called "s3", which was designed to improve the body's response to the vaccine.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 40 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Individuals 40 - 64 years of age
- Received at least two doses of a COVID-19 mRNA vaccine (Moderna or Pfizer) \> 120 days before study entry
- Nasal SARS-CoV-2 negative by molecular (polymerase chain reaction, PCR) testing at screening
- The following laboratory criteria must be met at screening:
- Total white blood cell (WBC) count \> 3500 cells/mm3
You likely can't join if
- Participants are excluded from the study if any of the following criteria are met:
- Pregnant or breastfeeding
- For participants capable of becoming pregnant and engaging in sexual activity that can lead to pregnancy, unwillingness to use contraception during...
- Condoms (male or female) with or without a spermicidal agent
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
See the full eligibility criteria
Who can join
- Individuals 40 - 64 years of age
- Received at least two doses of a COVID-19 mRNA vaccine (Moderna or Pfizer) \> 120 days before study entry
- Nasal SARS-CoV-2 negative by molecular (polymerase chain reaction, PCR) testing at screening
- The following laboratory criteria must be met at screening:
- Total white blood cell (WBC) count \> 3500 cells/mm3
- Absolute neutrophil count (ANC) \> 1500 cells/mm3
- Hemoglobin \> 13.5 g/dL if male sex and \> 12.0 g/dL if female sex
- Platelet count \> 140,000/uL
- Estimated creatinine clearance (CrCl) \> 50 mL/min by Cockroft-Gault equation
- Total bilirubin ≤ 1.1x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 1.3x ULN
- Alanine aminotransferase (ALT) ≤ 1.3x ULN
- Individuals of reproductive potential must have a negative serum or urine beta-human chorionic gonadotropin (ß-HCG) test at screening and within 48 hours prior to entry. Reproductive potential is defined as:
- Participants who have reached menarche
- Participants who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥40 IU/mL or 24 consecutive months if an FSH is not available
- Participants who have not undergone surgical contraception (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or bilateral salpingectomy) NOTE: Participants who have undergone bilateral tubal...
- Able and willing to provide informed consent
What rules you out
- Participants are excluded from the study if any of the following criteria are met:
- Pregnant or breastfeeding
- For participants capable of becoming pregnant and engaging in sexual activity that can lead to pregnancy, unwillingness to use contraception during participation in the study. For participants capable of becoming...
- Condoms (male or female) with or without a spermicidal agent
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive such as oral birth control pills
- Known close contact with anyone with confirmed SARS-CoV-2 infection (defined as positive SARS-CoV-2 nucleic acid or antigen testing by laboratory-based or home self-test) within 2 weeks prior to expected study entry
- Plan to receive a non-study SARS-CoV-2 vaccine within 8 weeks after study entry
- HIV infection
- Hepatitis B core antibody or hepatitis B surface antigen positive at screening
- Current active hepatitis C. Participants must be hepatitis C virus (HCV) antibody negative or have evidence of cleared HCV infection. If the participant is HCV antibody positive or indeterminate, an unquantifiable HCV...
- History of cirrhotic liver disease
- History of thrombosis with thrombocytopenia syndrome (TTS), immune thrombocytopenia, thromboembolic events, capillary leak syndrome, other thrombotic disease or known increased risk of thrombosis due to genetic...
- History of or active autoimmune disease that has required systemic immunosuppressive or immunomodulatory therapy
- History of myocarditis, pericarditis, or myopericarditis
- Potential myocarditis or pericarditis identified at screening, defined as high-sensitivity troponin I (hsTnI) \> ULN or 12-lead ECG compatible with pericarditis WITH compatible symptoms (regardless of troponin I level)...
- History of Guillain-Barré syndrome
- History of coagulopathy or bleeding disorder considered a contraindication to intramuscular injection or phlebotomy
- Symptomatic acute or chronic illness requiring ongoing medical or surgical care, including requirement for new medications, in the past 3 months. Transient illnesses or injuries that are resolved prior to screening are...
- Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent
- Treatment with systemic immunosuppressive or immunomodulatory drugs, and/or exposure to any immunosuppressive/immunomodulatory drug in the 30 days prior to study entry (e.g. corticosteroid therapy equal to or exceeding...
- Active malignancy or history of malignancy within the 4 years prior to study entry. Non-melanoma skin cancers (such as basal or squamous cell skin cancers) and non-invasive cervical or anal intraepithelial lesions are...
- History of solid organ or hematopoietic stem cell transplantation
- History of primary immunodeficiency disorder
- Ongoing complications or morbidity associated with prior diagnoses of malignancies requiring continued medical or surgical intervention. Chronic stable complications or morbidity not requiring new medications or other...
- Administration or planned administration of blood products or licensed non-SARS-CoV-2 vaccines \<14 days prior to or within 14 days after study entry
- Receipt of any antibody-based therapy (investigational or approved) for prophylaxis or treatment of COVID-19 in the preceding 6 months
- Receipt of immunoglobulin therapy in the year prior to study entry or scheduled or anticipated immunoglobulin administration during the study period.
- Prior receipt of any non-mRNA SARS-CoV-2 vaccine
- Receipt of any SARS-CoV-2 vaccination in the 120 days prior to study entry
- Documented SARS-CoV-2 infection in the 120 days prior to study entry
- History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention (medications requiring a prescription or surgical intervention) after receipt of a vaccine or intervention that...
- Have participated in an treatment clinical study within 28 days prior to screening (based on medical history interview) or plans to do so while participating in this study
- Any clinical concerns as determined by the investigator that might affect the potential participant's safety in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
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 - 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, 40 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.