Phase 1
N=23
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
HIV
Bottom Line
View on ClinicalTrials.gov: NCT05627258 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration — 3; 2; 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC-HIVMAB0115-00-AB (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration |
3; 2; 2; 3; 3; 4 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration |
3; 3; 3; 2; 2; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events Following Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration |
0; 0; 1; 3; 2; 2 | — |
| PRIMARY Number of Participants With New Chronic Medical Conditions Following Product Administration |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of VRC01.23LS: Maximum Observed Serum Concentration (Cmax) |
96.4; 13.4; 343.5; 719.8; 14.1; 12.9 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of VRC01.23LS: Time to Reach Maximum Observed Serum Concentration (Tmax) |
0.024; 2.9; 0.024; 0.042; 2.7; 2.9 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of VRC01.23LS: Beta Half-life (T1/2b) |
27.2; 43.3; 51.4; 53.6; 53.3; 40.9 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of VRC01.23LS: Clearance Rate |
395.6; 667.5; 478.2; 504.4; 688; 458.1 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of VRC01.23LS: Volume of Distribution |
14.7; 38.2; 32.3; 35.6; 44.7; 24.7 | — |
Summary
Background:
HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it. Antibodies may offer a promising new way to prevent HIV infection. Antibodies are proteins that are naturally made by the body to fight germs. One antibody (VRC01.23LS) has been tested in the lab and was found to block HIV-like viruses. Researchers want to find out if it is safe to inject VRC01.23LS into people.
Objective:
To test the safety of VRC01.23LS in healthy adults.
Eligibility:
Healthy people aged 18 to 60 years.
Design:
Participants were divided into 6 groups:
Some got 1 dose of VRC01.23LS. They visited the clinic up to 14 times in 24 weeks.
Some got 3 doses, each 12 weeks apart. They had 25 clinic visits over 48 weeks.
For some participants, the drug was given through a tube attached to a needle inserted into a vein in the arm. This took about 30 to 90 minutes. Others received the drug as an injection under the skin in a fatty area of the belly, arm, or thigh; each dose may have needed up to 3 individual injections.
Participants stayed in the clinic up to 8 hours on the days they received VRC01.23LS.
Participants received a thermometer and measuring tool. They checked their temperature daily for 7 days after they received the study drug. They measured any redness, swelling, or bruising at the injection site.
Eligibility Criteria
- INCLUSION CRITERIA:
A subject must meet all of the following criteria:
- Willing and able to complete the informed consent process.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Available for clinical follow-up through the last study visit.
- 18 to 60 years of age.
- In good general health without clinically significant medical history.
- Physical examination without clinically significant findings within the 56 days prior to enrollment.
- Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to SC group.
- Willing to have blood samples collected, stored indefinitely, and used for research purposes.
Laboratory Criteria within 56 days prior to enrollment:
- White blood cell count (WBC): 2,500-12,000/mm3.
- WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
- Platelets: 125,000 - 500,000/mm3.
- Hemoglobin within institutional normal range or accompanied by PI or designee approval.
- Creatinine: 115 kg.
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.
- Hypertension that is not well controlled.
- Receipt of any investigational study product within 28 days prior to enrollment (Note: Emergency Use Authorization of a COVID-19 vaccine is not exclusionary).
- Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.
- Receipt of any live attenuated vaccine within 28 days prior to enrollment.
- Receipt of any vaccine within 2 weeks prior to enrollment.
- 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.
- Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, or cancer.
Data sourced from ClinicalTrials.gov (NCT05627258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.