Influenza Prevention study: VRC-FLUMOS0122-00-VP vs ALFQ
Official title Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
ClinicalTrials.gov ID: NCT07111078
What this study is testing
What is VRC-FLUMOS0122-00-VP?
This is an investigational vaccine being studied to help prevent influenza (flu). It is designed to show the immune system specific parts of four different flu viruses to help the body learn to recognize them.
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
- This study checks if a new flu vaccine works better when mixed with a special ingredient called an adjuvant.
- Who it's for
- Healthy adults aged 18 to 50 who have had at least one flu vaccine since 2020.
- What's involved
- Participants get two shots in the upper arm, spaced four months apart. They will have blood draws, nose and mouth swabs, and keep a symptom diary for one week after each shot.
- Time commitment
- The study lasts 15 months and includes 12 clinic visits and 4 phone calls.
- Phase 1: an early, usually small safety study
- Time commitment: about 15 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy adults between the ages of 18-50 years, inclusive
- Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the
You likely can't join if
- Received at least one licensed influenza vaccine within the 5 years prior to enrollment
- Able and willing to complete the informed consent process
- The ability to read and comprehend English as all consent and recruitment materials are in English.
- Available for clinic visits for 68 weeks after the first dose
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \<= 35 within the 56 days before...
See the full eligibility criteria
- Healthy adults between the ages of 18-50 years, inclusive
- Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the
- Received at least one licensed influenza vaccine within the 5 years prior to enrollment
- Able and willing to complete the informed consent process
- The ability to read and comprehend English as all consent and recruitment materials are in English.
- Available for clinic visits for 68 weeks after the first dose
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \<= 35 within the 56 days before enrollment
- Agrees to not receive any licensed influenza vaccination during study participation due to potential confounding of study results
- WBC and differential within institutional normal range or accompanied by approval of the site Principal Investigator (PI) or designee
- Total lymphocyte count \>= 800 cells/microliter
- Platelets = 125,000-400,000 cells/mircoliter
- Hemoglobin within institutional normal range or accompanied by approval of the PI or designee
- Alanine aminotransferase (ALT) \<= 1.25 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) \<= 1.25 x institutional ULN
- Alkaline phosphatase (ALP) \< 1.1 x institutional ULN
- Total bilirubin within institutional normal range or accompanied by approval of the PI or designee
- Serum creatinine \<= 1.1 x institutional ULN
- Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment
- Receipt of any licensed influenza vaccine or lab-confirmed influenza infection within 6 months prior to enrollment.
- Plan to or is required to receive a licensed influenza vaccine during study participation
- Live attenuated vaccines within 4 weeks prior to enrollment
- Inactivated vaccines within 2 weeks prior to enrollment
- mRNA vaccines within 4 weeks prior to enrollment
- Receipt of the HA ferritin influenza vaccine VRC-FLUNPF081-00-VP alone or in prime-boost regimens with VRC-FLUDNA082-00-VP (HA-F A/Sing, DNA A/Sing, VRC 316).
- Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1, VRC 325)
- Receipt of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2, VRC 326)
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
- Serious reactions to vaccines that preclude receipt of the study vaccinations as determined by the PI or designee
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is not well controlled
- Diabetes mellitus (type I or II), except for gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Immune-mediated diseases, such as autoimmune or autoinflammatory diseases, or immunodeficiencies
- Hypertension that is not well controlled
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or history of malignancy that is likely to recur during the period of the study
- Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barr(SqrRoot)(Copyright) Syndrome
- Any medical, social condition, occupational reason, or other reason that, in the judgment of the PI or designee, is a contraindication to protocol participation or impairs a participant's ability to give informed...
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 15 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.