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Monoclonal Antibodies
VRC01.23LS Antibody for HIV Prevention
Phase 1
Waitlist Available
Led By Lesia K Dropulic, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 weeks after last product administration
Awards & highlights
Study Summary
This trial will test if a new antibody, VRC01.23LS, is safe to inject in healthy adults.
Who is the study for?
Healthy adults aged 18 to 60 who are willing to have blood samples stored and used for research, can provide proof of identity, and agree to clinical follow-up. Women must use birth control and have a negative pregnancy test. Excluded are those with certain medical conditions, severe allergies, or recent receipt of other investigational products.Check my eligibility
What is being tested?
The trial is testing the safety of VRC01.23LS, an antibody that may prevent HIV infection. Participants will receive either one dose or three doses over several weeks via IV or subcutaneous injection in different body parts and will be monitored closely after administration.See study design
What are the potential side effects?
Potential side effects aren't detailed but monitoring includes checking temperature daily for a week post-injection and measuring any redness, swelling, or bruising at the injection site which suggests local reactions could be expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of VRC01.23LS (20 mg/kg IV) administered for a total of 3 injections in 12 week intervals to healthy adults
Safety and tolerability of VRC01.23LS (20 mg/kg IV) administered to healthy adults
Safety and tolerability of VRC01.23LS (40 mg/kg IV) administered to healthy adults
+3 moreSecondary outcome measures
PK will be evaluated at each dose level and route of administration.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Group 6Experimental Treatment1 Intervention
20 mg/kg IV repeat dosing
Group II: Group 5Experimental Treatment1 Intervention
5 mg/kg SC repeat dosing
Group III: Group 4Experimental Treatment1 Intervention
40 mg/kg IV single administration
Group IV: Group 3Experimental Treatment1 Intervention
20 mg/kg IV single administration
Group V: Group 2Experimental Treatment1 Intervention
5 mg/kg SC single administration
Group VI: Group 1Experimental Treatment1 Intervention
5 mg/kg IV single administration
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,092 Total Patients Enrolled
Lesia K Dropulic, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
3,569 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently breastfeeding or planning to get pregnant during the study.My high blood pressure is not well controlled.I have good veins for IV treatment or enough belly fat for shots.I have not received any vaccines in the last 2 weeks.My weight is over 115 kg.I have received an experimental HIV vaccine or antibody.I am between 18 and 60 years old.I have a bleeding disorder or experience significant bleeding or bruising.I agree to give blood samples for indefinite research use.I am in good health with no major medical issues.I have a negative pregnancy test result on the day I join the study.I have not received a live vaccine in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4
- Group 2: Group 6
- Group 3: Group 3
- Group 4: Group 1
- Group 5: Group 5
- Group 6: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity to be a participant in this experiment?
"The enrollment criteria for this trial stipulate that applicants must have HIV and be between 18 to 60 years old. In total, 40 people are needed in order to complete the experiment."
Answered by AI
What is the current enrollment of this experiment?
"Affirmative. According to the clinicaltrials.gov website, this medical investigation is actively recruiting participants. This research was initially listed on December 4th 2022 and its details were recently updated on November 28th 2022. The researchers hope to recruit 40 patients from one site only."
Answered by AI
Has Group 4 acquired authorization from the FDA?
"As Group 4 is currently in Phase 1, our team at Power assesses its safety with a score of 1 due to the lack of evidence for both efficacy and safety."
Answered by AI
Is there an ongoing opportunity to join the experiment?
"According to information published on clinicaltrials.gov, this medical trial is actively seeking patients for participation. The original post date was December 4th 2022 and the most recent edit occurred November 28th of that same year."
Answered by AI
Is this investigation enrolling elderly individuals aged 80 and above?
"Patients aged 18 to 60 are eligible for this trial as per its inclusion criteria. Separately, there are 57 and 176 studies available respectively for individuals below the age of consent and those above 65 years old."
Answered by AI
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