Phase 1
N=26
VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
HIV Prevention
Bottom Line
View on ClinicalTrials.gov: NCT03015181 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration — 3; 3; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC-HIVMAB075-00-AB (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration |
3; 3; 3; 2; 3; 3 | — |
| PRIMARY Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration |
3; 3; 2; 3; 5; 4 | — |
| PRIMARY Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events |
0; 0; 0; 0; 2; 0 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups |
47; 240; 50; 869; 1630 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups |
38; 1196; 37; 799 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS |
0.7; 0.04; 10; 0.3; 0.04; 5.7 | — |
| SECONDARY 4 Week Mean Serum Concentration of VRC07-523LS |
14; 57; 31; 148; 272; 25 | — |
| SECONDARY 12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups |
3.8; 57; 7.1; 44; 85 | — |
| SECONDARY 12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups |
6.3; 46; 9.8; 71 | — |
| SECONDARY Area Under the Curve (AUC(0-inf)): Single Dose Groups |
1381; 4551; 2189; 13748; 25517 | — |
| SECONDARY Area Under the Curve (AUC0-84D): Multiple Dose Groups |
1440; 14760; 1671; 13573 | — |
| SECONDARY VRC07-523LS Clearance Rate |
70; 78; 110; 105; 101; 94 | — |
| SECONDARY Overall IV Half-life (T1/2) of VRC07-523LS |
48; 32; 45; 42; 27; 38 | — |
| SECONDARY Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS |
0; 0; 0; 0; 0; 0 | — |
Summary
Background:
Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infected people.
Objective:
To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy adults.
Eligibility:
Healthy people ages 18-50
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Participants will be assigned to 1 of 7 groups:
Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.
Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48 weeks.
Participants will get the drug in 1 of 2 ways:
Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6 hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will have 4-5 visits in the week after their second and third doses.
Injection into the fatty tissue under the skin. Participants will have blood tests before the injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits after the second and third doses.
Visits include:
Physical exam
Blood and urine tests
Optional oral swabs to collect saliva
Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
Eligibility Criteria
- INCLUSION CRITERIA:
A volunteer must meet all of the following criteria:
- Able and willing to complete the informed consent process.
- 18 to 50 years of age.
- Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria.
- Willing to have blood samples collected, stored indefinitely, and used for research purposes.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Willing to adhere to reduced risk sexual behavior during study participation.
- Screening laboratory values within 84 days prior to enrollment must meet the following criteria:
- White Blood Cell (WBC) 2,500-12,000/mm^3.
- WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
- Platelets = 125,000 - 400,000/mm^3.
- Hemoglobin within institutional normal range.
- Creatinine less than or equal to 1.1 x upper limit of normal (ULN).
- Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN.
- Negative for HIV infection by the FDA approved method of detection.
- Female-Specific Criteria:
- If a woman is of reproductive potential and sexually active with a male partner, then she agrees to use an effective means of birth control from the time of study enrollment until the last study visit, or to be monogamous with a partner who has had a vasectomy.
- Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
EXCLUSION CRITERIA
A volunteer will be excluded if one or more of the following conditions apply:
- Previous receipt of licensed or investigational monoclonal antibody.
- Weight >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.
- Woman who is breast-feeding, or planning to become pregnant during the study participation.
- Receipt of any investigational study agent within 28 days prior to enrollment.
- 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, autoimmune disease, psychiatric disorders, heart disease, or cancer.
Data sourced from ClinicalTrials.gov (NCT03015181). 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.