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HIV Vaccine for HIV Prevention
Study Summary
This trial is designed to improve our understanding of how to create a vaccine that can elicit VRC01-class antibodies, which are broad-spectrum and have been shown to be effective in preventing HIV acquisition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I do not have a spleen or my spleen does not work properly.I am willing and able to understand and sign the consent form.I have a seizure disorder.My BMI is 40 or higher, but I may still be considered for the trial.I have Type 2 diabetes but it's controlled by diet or I had gestational diabetes only.I started allergy immunotherapy in the last year.I have not received any vaccines in the last 4 weeks.I have previously received the VRC01 monoclonal antibody treatment.I have a bleeding disorder diagnosed by a doctor.I am between 18 and 55 years old.I have asthma.I have not received blood products or immunoglobulin in the last 16 weeks.I have not taken steroids stronger than prednisone 10 mg/day in the last 3 months.I have a diagnosed form of angioedema.I can attend all clinic visits, agree to a lymph node biopsy, and be contacted for a year after my last vaccine dose.I haven't taken any experimental drugs with a short half-life in the last 4 weeks.You have a low risk of getting HIV and can prove it by following certain guidelines. You will also have to discuss the risks of getting HIV and how to avoid it during the study.I am between 18 and 55 years old.I am between 18 and 55 years old.
- Group 1: Bolus Delivery, Group 1: First injection - Medium dose, Final injection - Lower dose
- Group 2: Bolus Delivery, Group 2: First injection - Medium dose, Final injection - Higher dose
- Group 3: Bolus Delivery, Group 3: First injection - Placebo, Final injection - Placebo
- Group 4: Fractionated Delivery, Group 1: First injection - Medium dose, Final injection - Lower dose
- Group 5: Fractionated Delivery, Group 2: First injection - Medium dose, Final injection - Higher dose
- Group 6: Fractionated Delivery, Group 3: First injection - Placebo, Final injection - Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What deleterious impacts might result from administering 426c.Mod.Core-C4b 100 mcg to individuals?
"Rated on a scale from 1 to 3, the 426c.Mod.Core-C4b 100 mcg drug was awarded a score of 1 due to its limited data regarding safety and efficacy as it is only in Phase I trials."
Does the eligibility criteria for this trial encompass those aged eighty and above?
"Conforming to this clinical trial's requirements, the youngest possible participant must be 18 years of age while the oldest cannot surpass 55."
Is this research endeavor still open to additional participants?
"According to the clinicaltrials.gov listing, this study is in need of participants. It was initially published on August 22nd 2022 and most recently updated November 21st 2022."
At how many separate sites has this research been implemented?
"The research team requires participants to join from 8 different clinical trial sites, including Brigham and Women's Hospital Vaccine CRS (BWH VCRS) in Boston, Massachusetts; Alabama CRS in Birmingham, Alabama; and Seattle Vaccine and Prevention CRS in Seattle, Washington."
How many volunteers are being enrolled in this clinical experiment?
"Affirmative. Clinicaltrials.gov showcases that, as of November 21st 2022, this clinical trial is enrolling participants. The study was first publicized on August 22nd 2022 and requires the recruitment of 52 individuals across 6 sites."
Who meets the eligibility criteria to participate in this research endeavor?
"This clinical trial is admitting 52 adults aged 18-55 who have been diagnosed with HIV-1. These participants must also meet the following qualifications: consent to the informed process, be in good general health, possess laboratory results without clinically significant findings, evaluate as low risk for HIV acquisition according to guidelines given by the site investigator, agree not to enroll in another investigational drug study during participation and make themselves available through their last clinic visit, be willing to undergo lymph node fine needle aspiration if required and allow follow up contact 12 months after final vaccine administration. Additionally they must present a haemoglobin count of 11 g/dL or above (for"
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
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