This study is NOT currently recruiting participants.
Number
20-I-0096
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 60 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
HIV Prevention; Broadly-Neutralizing Human Monoclonal Antibodies; First in Human; Anti-Drug Antibody Response; Antibodies
Recruitment Keyword(s)
None
Condition(s)
HIV
Investigational Drug(s)
VRC-HIVMAB0102-00-AB
Investigational Device(s)
Intervention(s)
Biological/Vaccine: VRC-HIVMAB0102-00-AB
Supporting Site
National Institute of Allergy and Infectious Diseases
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. Researches 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 will be screened with a medical history, physical exam, and blood tests. Some will have a pregnancy test.
Participants will be assigned to one of two groups. Based on their group, they will get 1 dose of CAP256V2LS in 1 of 2 ways:
-Some participants will get CAP256V2LS as an infusion. A thin tube will be placed in an arm vein. CAP256V2LS will be given into the vein using a pump.
-Some participants will get CAP256V2LS injected under the skin. A small needle will inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They will get 1 to 4 injections.
On the day they get CAP256V2LS, participants will give blood samples at different time points. This visit will last about 8 hours.
Participants will be asked to check their temperature every day for 7 days after receiving CAP256V2LS. They will use a tool to measure any redness, swelling, or bruising they may have at the injection site.
Participants will have visits at least 2-3 times during the first week after they get CAP256V2LS. Then they will have about 9 more visits over the next 6 months. Visits will include blood tests.
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INCLUSION CRITERIA: A subject must meet all of the following criteria to be included: 1. Able and willing to complete the informed consent process 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process 3. Available for clinical follow-up through the last study visit 4. 18 to 60 years of age 5. Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment. 6. Weight 115 kg 7. Willing to have blood samples collected, stored indefinitely, and used for research purposes Laboratory Criteria within 84 days prior to enrollment: 8. White Blood Cell (WBC) 2,500-12,000/mm3 9. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval 10. Platelets = 125,000 500,000/mm3 11. Hemoglobin within institutional normal range or accompanied by the PI or designee approval 12. Creatinine 1.1 x upper limit of normal (ULN) based on the institutional normal range 13. Alanine aminotransferase (ALT) 1.25 x ULN based on the institutional normal range 14. Negative for HIV infection by an FDA approved method of detection Criteria Specific to Women of Childbearing Potential: 15. Negative beta-human chorionic gonadotropin ( <=-HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration 16. 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 subject will be excluded if one or more of the following conditions apply: 1. Woman who is breast-feeding or planning to become pregnant during study participation 2. 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 3. Hypertension that is not well controlled 4. 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. 5. Receipt of any live attenuated vaccines within 28 days prior to enrollment. 6. Receipt of any vaccine within 2 weeks prior to enrollment/product administration 7. Prior receipt of a licensed or investigational monoclonal antibody 8. Prior receipt of an HIV vaccine 9. 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 subject s ability to give informed consent.
A subject must meet all of the following criteria to be included:
1. Able and willing to complete the informed consent process
2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
3. Available for clinical follow-up through the last study visit
4. 18 to 60 years of age
5. Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment.
6. Weight 115 kg
7. Willing to have blood samples collected, stored indefinitely, and used for research purposes
Laboratory Criteria within 84 days prior to enrollment:
8. White Blood Cell (WBC) 2,500-12,000/mm3
9. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval
10. Platelets = 125,000 500,000/mm3
11. Hemoglobin within institutional normal range or accompanied by the PI or designee approval
12. Creatinine 1.1 x upper limit of normal (ULN) based on the institutional normal range
13. Alanine aminotransferase (ALT) 1.25 x ULN based on the institutional normal range
14. Negative for HIV infection by an FDA approved method of detection
Criteria Specific to Women of Childbearing Potential:
15. Negative beta-human chorionic gonadotropin ( <=-HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration
16. 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 subject will be excluded if one or more of the following conditions apply:
1. Woman who is breast-feeding or planning to become pregnant during study participation
2. 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
3. Hypertension that is not well controlled
4. 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.
5. Receipt of any live attenuated vaccines within 28 days prior to enrollment.
6. Receipt of any vaccine within 2 weeks prior to enrollment/product administration
7. Prior receipt of a licensed or investigational monoclonal antibody
8. Prior receipt of an HIV vaccine
9. 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 subject s ability to give informed consent.
Principal Investigator
Referral Contact
For more information: