Is NCT06810934 recruiting in Los Angeles, CA?

Yes, NCT06810934 is currently recruiting participants at its Los Angeles, CA location. This covid-19 clinical trial is actively enrolling qualified participants.

How do I join the covid-19 clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

COVID-19 Clinical Trial in Los Angeles, CA

About This COVID-19 Study in Los Angeles

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. CoTend-BXBB is the same vaccine without s3. The main questions the study aims to answer are: 1) Is the investigational vaccine safe? 2) Does "s3" lead to bigger, broader, and longer-lasting responses to the vacc

Sponsor: Kara Chew

Who Can Participate

Inclusion Criteria

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 ligation within the 24 weeks prior to screening are considered to be of reproductive potential and, if participating in sexual activity that could lead to pregnancy, contraception is required as per 5.2.2

Exclusion Criteria

criterion 2.

Able and willing to provide informed consent Exclusion Criteria: 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 pregnant, two of the following forms of contraception are required through 30 days following administration of study intervention, one of which must be a barrier method:

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 RNA result (below lower limit of quantification, either target detected or target not detected) within 42 days prior to study entry is required. Those who are currently receiving HCV antiviral therapy or those who have received HCV treatment in the last 3 months prior to study entry will be excluded.

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 disorders or malignancy

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) at screening

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 not exclusionary. Minor adjustments in stable therapy for chronic conditions such as hypertension are not exclusionary. Use of over-the-counter medications for any acute or chronic illness is also not exclusionary.

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 a dose of 20 mg/day of prednisone for more than 10 days, interleukins, interferons, methotrexate, rituximab, and cancer chemotherapy). Use of topical, inhaled, intra-articular, or nasal steroid use is not exclusionary.

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 not exclusionary.

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 medical or surgical intervention in the past 3 months are not exclusionary.

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 includes one or more of the same components contained in the study product

Have participated in an interventional 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT06810934) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

COVID-19 Treatment Options in Los Angeles, CA

If you're searching for covid-19 treatment options in Los Angeles, CA, this clinical trial (NCT06810934) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced covid-19 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all covid-19 clinical trials near you to find additional studies recruiting in your area.

COVID-19 Clinical Trial in Los Angeles, CA

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