A Randomized, Parallel-group, Placebo-controlled, Double-blind Phase 1 Study in Healthy HIV-uninfected Adults to Evaluate Safety/Tolerability and Immunogenicity of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C gp140
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Titer to HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay
研究概览
简要总结
The primary purpose of this study is to assess safety, tolerability of the different vaccine schedules (different regimen durations and different number of dose administrations) with Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody (Ab) responses of the different vaccine schedules.
详细描述
This is a phase 1 single-center, randomized (the study drug is assigned by chance), parallel group (each group of participants will be treated at the same time), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. Participants will be randomized in to 3 groups and will receive study vaccines or placebo. Group 1 will have 4 vaccination time points during 48 weeks, Groups 2 and 3 will have 3 vaccination time points during 24 weeks. The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (maximum 48 weeks), and a Follow-up Period (up to 72 weeks). Participants' safety will be monitored throughout the study. An optional Long-term Extension (LTE) phase (approximately 1 year after Week 72) will be performed for participants randomized to receive study vaccine, who have received all planned vaccinations and are negative for HIV infection at Week 72. The duration of the participation will be approximately 124 weeks for participants participating to the optional LTE phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is voluntarily willing to participate in the study
- •Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at Screening
- •Participants are negative for Human Immunodeficiency Virus (HIV) infection at Screening
- •All female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [beta hCG]) at the Screening visit, and a negative urine pregnancy test pre-dose on Day 1
- •Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
排除标准
- •Participant has chronic hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented by serology unless positive serology is due to past treated infection
- •In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2, syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B
- •Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- •Participant has had major surgery within 4 weeks prior to Screening or planned major surgery through the course of the study
- •Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months
研究组 & 干预措施
Group 1A
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
干预措施: Ad26.Mos.HIV (Biological)
Group 1A
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
干预措施: Clade C gp140 (Biological)
Group 1B
Participants will receive placebo at weeks 0, 12, 24 and 48.
干预措施: Placebo (Drug)
Group 2A
Participants will receive Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 0, 12 and 24.
干预措施: Ad26.Mos.HIV (Biological)
Group 2A
Participants will receive Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 0, 12 and 24.
干预措施: Clade C gp140 (Biological)
Group 2B
Participants will receive placebo at weeks 0, 12 and 24.
干预措施: Placebo (Drug)
Group 3A
Participants will receive Ad26.Mos.HIV vaccine at Week 0; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 8 and 24.
干预措施: Ad26.Mos.HIV (Biological)
Group 3A
Participants will receive Ad26.Mos.HIV vaccine at Week 0; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 8 and 24.
干预措施: Clade C gp140 (Biological)
Group 3B
Participants will receive placebo at weeks 0, 8 and 24.
干预措施: Placebo (Drug)
结局指标
主要结局
Titer to HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay
时间窗: Up to Week 72
Breadth of HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay
时间窗: Up to Week 72
Number of Participants With Local and Systemic Reactogenicity for 8 Days After Each Vaccination
时间窗: Up to 8 days after each vaccination
Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema or swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 8 days post-vaccination. These occurrences will be recorded through the diary card provided to serve as a reminder to the participants for the next clinic visit.
Treatment Emergent Adverse Events (AEs)
时间窗: Up to Week 72
Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
时间窗: Up to Week 124
Discontinuations From Vaccination or From Study due to AEs
时间窗: At the time of discontinuation from vaccination or from study (Up to Week 72)
Number of Participants With AEs or SAEs
时间窗: Up to 28 days after each vaccination
次要结局
- Env-Specific Functional Antibodies: Phagocytosis Score(Up to Week 72)
- Env-Specific Functional Antibodies: Breadths(Up to Week 72)
- Env-Specific Neutralizing Antibodies (nAbs): Titers(Up to Week 72)
- Env-Specific Neutralizing Antibodies (nAbs): Breadths(Up to Week 72)
- Induction of New T-cell Immune Response by the Vaccine(Up to Week 72)
- Env-Specific Binding Antibody Isotypes: Titers(Up to Week 72)
- Env-Specific Binding Antibody Isotypes: Breadths(Up to Week 72)
- Change From Baseline of the Frequency of HIV-Specific PBMC and/or CD4 and/or CD8 T cells as Measured by ELISpot Interferon (IFN) Gamma(Up to Week 72)