This study is NOT currently recruiting participants.
Number
18-I-0105
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: 50 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Immune Cells; bNAb; Plasma Cell; HIV; Immunotherapy
Recruitment Keyword(s)
None
Condition(s)
HIV Antibodies
Investigational Drug(s)
VRC-HIVMAB091-00-AB
Investigational Device(s)
Intervention(s)
Biological/Vaccine: VRC-HIVMAB091-00-AB Biological/Vaccine: EDP
Supporting Site
National Institute of Allergy and Infectious Diseases
The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same. N6LS is directed against the HIV virus. There is no HIV in the N6LS study product and you cannot get HIV from this product. This study will be the first time N6LS is tested in humans. It will be given into a vein in your arm (intravenously, IV) or as an injection underneath your skin (subcutaneously, SC). The study will also test N6LS mixed with an enzyme, rHuPH20 (recombinant human hyaluronidase). rHuPH20 increases the spread of fluids injected underneath your skin (subcutaneously, SC) and allows for the rapid delivery of large volume injections that can be given with a single needle. It will be given as a SC infusion using a small needle attached to an infusion pump. Study products will only be given to healthy adults who are not infected with HIV.
Objective:
The main purpose of the study is to see if N6LS alone and N6LS mixed with rHuPH20 is safe in healthy adults. Another goal is to learn how amounts of N6LS in the body change over time.
You may be eligible to participate if you are:
- 18 to 50 years old
- Willing to get N6LS or N6LS with rHuPH20
- Available for clinical follow-up for 6-11 months after enrollment
- Willing to donate blood to be stored indefinitely for research use
- In general good health
You will not be eligible to participate if you:
- Have received a licensed or investigational monoclonal antibody in the past
- Have a known sensitivity any ingredient in EDP
- Weigh more than 253 pounds (115 kg)
- Have HIV infection
Women must not be pregnant and must agree to use an effective method to prevent pregnancy during the entire study.
Study Plan:
32 to 40 healthy volunteers will be enrolled into 8 groups. Assigned study groups will depend on the dose of product, the numbers of times the product is given (once or three times at 12- week intervals), and how the product is given (IV or SC). Blood samples for research will be collected at most of the visits. There are about 14 clinic visits over 6 months for all groups getting one dose of product, and about 26 clinic visits over 12 months for the groups getting three doses of product. Participants will be compensated for their time and inconvenience.
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INCLUSION CRITERIA: A subject must meet all of the following criteria: 1. Willing and able to complete the informed consent process. 2. 18 to 50 years of age. 3. Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria. 4. Willing to have blood samples collected, stored indefinitely, and used for research purposes. 5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 6. Screening laboratory criteria within 84 days prior to enrollment must meet the following criteria: - White blood cell count (WBC): 2,500-12,000/mm(3). - WBC differential: 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 or accompanied by PI or designee approval. - Creatinine: less than or equal to 1.1 x Upper Limit of Normal (ULN). - ALT: less than or equal to 1.25 x ULN. - AST: less than or equal to 1.25 x ULN. - Negative for HIV infection by an FDA approved method of detection. Female-Specific Criteria: 7. 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. 8. 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 subject will be excluded if one or more of the following conditions apply: 1. Prior receipt of licensed or investigational monoclonal antibody. 2. Weight > 115 kg. 3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study. 4. Hypertension that is not well controlled. 5. Woman who is breast-feeding, or planning to become pregnant during the study participation. 6. Receipt of any investigational study agent within 28 days prior to enrollment. 7. Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, infectious disease, psychiatric disorders, heart disease, or cancer. 8. Known hypersensitivity to hyaluronidase or any of the excipients in EDP.
A subject must meet all of the following criteria:
1. Willing and able to complete the informed consent process.
2. 18 to 50 years of age.
3. Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria.
4. Willing to have blood samples collected, stored indefinitely, and used for research purposes.
5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
6. Screening laboratory criteria within 84 days prior to enrollment must meet the following criteria:
- White blood cell count (WBC): 2,500-12,000/mm(3).
- WBC differential: 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 or accompanied by PI or designee approval.
- Creatinine: less than or equal to 1.1 x Upper Limit of Normal (ULN).
- ALT: less than or equal to 1.25 x ULN.
- AST: less than or equal to 1.25 x ULN.
- Negative for HIV infection by an FDA approved method of detection.
Female-Specific Criteria:
7. 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.
8. 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 subject will be excluded if one or more of the following conditions apply:
1. Prior receipt of licensed or investigational monoclonal antibody.
2. Weight > 115 kg.
3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
4. Hypertension that is not well controlled.
5. Woman who is breast-feeding, or planning to become pregnant during the study participation.
6. Receipt of any investigational study agent within 28 days prior to enrollment.
7. Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, infectious disease, psychiatric disorders, heart disease, or cancer.
8. Known hypersensitivity to hyaluronidase or any of the excipients in EDP.
Principal Investigator
Referral Contact
For more information: