Status:
COMPLETED
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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...
Detailed Description
Design: This open-label study evaluated CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04408963
Start Date
March 22 2022
End Date
November 28 2022
Last Update
January 11 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892