VRC 610: Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently With MAB VRC-HIVMAB075-00-AB (VRC07-523LS) Via Subcutaneous Injection in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
研究概览
简要总结
Background:
Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV. Antibodies are naturally made by the body to fight germs. Researchers want to test if two antibodies made artificially in a lab can help to prevent HIV infection. The antibodies are 10E8VLS and VRC07-523LS.
Objective:
To see if 10E8VLS and VRC07-523LS are safe and well-tolerated and how long they stay in the blood.
Eligibility:
Healthy adults ages 18-60
Design:
Volunteers were screened in another protocol.
Participants were enrolled in 1 of 4 groups:
Group 1 participants were enrolled to receive 1 dose of 10E8VLS.
Group 2 participants were enrolled to receive 3 doses of 10E8VLS.
Group 3 participants were enrolled to receive 1 dose of both 10E8VLS and VRC07-523LS.
Group 4 participants were enrolled to receive 3 doses of both 10E8VLS and VRC07-523LS.
Participants in Groups 1 and 3 were expected to be enrolled about 13 visits over 24 weeks.
Participants in Groups 2 and 4 were expected to be enrolled about 26 visits over 48 weeks.
Participants were weighed before each dose. Women may have had a pregnancy test. Participants had blood collected.
A small needle injected each dose into fatty tissue of the belly, upper arm, or thigh. Participants received between 1 and 8 injections per dose depending on their weight. Heavier participants received more injections.
Participants received a ruler and thermometer. They checked their temperature for 3 days after injection(s) and measured any redness, swelling, or bruising at the injection site.
At non-injection visits, participants had blood drawn and were checked for health changes or problems.
详细描述
VRC 610:
A Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently with MAB VRC-HIVMAB075-00-AB (VRC07-523LS) Via Subcutaneous Injection in Healthy Adults
Study Design:
This first-in-human, open-label study evaluated MAb 10E8VLS (VRC-HIVMAB095-00-AB) administered alone or concurrently (i.e., at the same visit) with MAb VRC07-523LS (VRC-HIVMAB075-00-AB) in healthy adults ages 18 to 60. The primary hypothesis was that administrations of 10E8VLS alone and concurrently with VRC07-523LS will be well-tolerated in healthy adults. A secondary hypothesis was that both broadly neutralizing monoclonal antibodies (bNAbs) will be detectable in human sera with a definable half-life.
Product Description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
时间窗: 3 days after product administration
Local symptoms were recorded by participants using a 3-day diary. Solicited local symptoms include pain/tenderness, bruising, redness, swelling, and pruritus (itchiness) at the product administration site. Clinicians reviewed the diary with the participant and collected resolution information for any symptoms that were not resolved within 3 days. Participants were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
时间窗: 3 days after product administration
Participants recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Participants recorded highest measured temperature daily. Clinicians reviewed the diary with the participant and collected resolution information for any symptoms that were not resolved within 3 days. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events
时间窗: Up to 24 weeks after product administration
Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after product administration. After the indicated time period through the last expected study visit at 24 weeks after product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of participants who experienced at least one AE in the reporting period. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With Serious Adverse Events
时间窗: Up to 24 weeks after product administration
Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the product administration.
次要结局
- Maximum Observed Serum Concentration (Cmax) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS(Up to 24 weeks after product administration)
- Clearance Rate of 10E8VLS Administered Alone or Concurrently With VRC07-523LS(Administration (0h) up to 28 days after product administration)
- Area Under the Curve (AUC0-28D) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS(Administration (0h) up to 28 days after product administration)
- Time to Reach Maximum Observed Serum Concentration (Tmax) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS(Up to 24 weeks after product administration)
- 4 Week Mean Serum Concentration of 10E8VLS Administered Alone or Concurrently With VRC07-523LS(Administration (0h) up to 28 days after product administration)
- Overall Half-Life (T1/2) of 10E8VLS Administered Alone or Concurrently With VRC07-523LS(Administration (0h) up to 28 days after product administration)