Phase 1
N=10
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
HIV
Bottom Line
View on ClinicalTrials.gov: NCT04408963 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration — 5; 4; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC-HIVMAB0102-00-AB (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration |
5; 4; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration |
0; 1; 2; 1; 3; 2 | — |
| PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CAP256V2LS Product Administration |
5; 3; 0; 0; 5; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Following CAP256V2LS Product Administration |
0; 0 | — |
| PRIMARY Number of Participants With New Chronic Medical Conditions Following CAP256V2LS Product Administration |
0; 0 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety Following CAP256V2LS Product Administration |
1; 0; 5; 3; 5; 3 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of CAP256V2LS: Maximum Observed Serum Concentration (Cmax) |
155.57; 58.69 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of CAP256V2LS: Time to Reach Maximum Observed Serum Concentration (Tmax) |
0.23; 6.32 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of CAP256V2LS: Beta Half-life (T1/2b) |
25.38; 27.00 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of CAP256V2LS: Clearance Rate |
84.32; 135.92 | — |
| SECONDARY Pharmacokinetic (PK) Parameters of CAP256V2LS: Volume of Distribution |
3.06; 5.29 | — |
Summary
Background:
HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS.
Objective:
To test CAP256V2LS to see if it is safe and how the body responds to it.
Eligibility:
Healthy people, ages 18-60
Design:
Participants were screened with a medical history, physical exam, and blood tests. Some females had a pregnancy test.
Participants were assigned to one of two groups. Based on their group, they got 1 dose of CAP256V2LS in 1 of 2 ways:
* Some participants got CAP256V2LS as an infusion. A thin tube was placed in an arm vein and CAP256V2LS was given into the vein using a pump.
* Some participants got CAP256V2LS injected under the skin. A small needle was used to inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They got 1 to 4 injections.
On the day they got CAP256V2LS, participants gave blood samples at different time points.
Participants were asked to check their temperature every day for 7 days after receiving CAP256V2LS. They used a tool to measure any redness, swelling, or bruising they may have at the site where they received the study drug.
Participants had visits at least 2-3 times during the first week after they got CAP256V2LS. Then they had about 9 more visits over the next 6 months. Visits included blood tests.
Eligibility Criteria
- INCLUSION CRITERIA:
A volunteer must have met all of the following criteria to be included:
- Able and willing 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
- Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment.
- Weight less than or equal to 115 kg
- Willing to have blood samples collected, stored indefinitely, and used for research purposes
Laboratory Criteria within 84 days prior to enrollment:
- 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 = 125,000-500,000/mm^3
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval
- Creatinine less than or equal to 1.1 x upper limit of normal (ULN) based on the institutional normal range
- Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN based on the institutional normal range
- Negative for HIV infection by an FDA approved method of detection
Criteria Specific to Women of Childbearing Potential:
- Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration
- Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the duration of study participation
EXCLUSION CRITERIA
A volunteer was excluded if one or more of the following conditions applied:
- Woman who is breast-feeding or planning to become pregnant during study participation
- 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: SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary.
- Receipt of any live attenuated vaccines within 28 days prior to enrollment.
- Receipt of any vaccine within 2 weeks prior to enrollment/product administration
- Prior receipt of a licensed or investigational monoclonal antibody
- Prior receipt of an HIV vaccine
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
Data sourced from ClinicalTrials.gov (NCT04408963). 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.