An Open Label Phase I Clinical Trial to Evaluate the Effect of Late Boost on HIV-uninfected Vaccinees From EV06 Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Safety and tolerability of the late boost vaccination
研究概览
简要总结
EV07 is an open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial.
The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated. Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection may modulate antibody responses induced by vaccination1.
Based on these preliminary immunogenicity results of the EV06 study, a study with an additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to better investigate and understand the effects of the late boost on the response rate, magnitude and durability of vaccine induced immune responses.
The primary objective of EV07 is to evaluate the ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participated in the EV06 trial and received all three vaccinations from EV06 trial
- •HIV uninfected adults, as confirmed by a medical history, physical exam, and laboratory tests during screening
- •Able and willing to provide written informed consent prior to screening
- •Aged at least 18 at the time of consent
- •Able and willing to complete screening (about 1 month) and available for the planned follow-up period (6 months)
- •Willing to undergo HIV testing, risk reduction counselling and receive HIV test results
- •If female of childbearing potential (unless sterilised), willing to use a non-barrier contraceptive method from screening through the end of the study. Acceptable contraceptive methods include hormonal contraceptives (injection, transdermal patch, or implant) and intrauterine device (IUD).
- •If male, willing to use male condoms and not make a woman pregnant from enrolment through the end of the study.
- •Willing to provide blood, urine and stool samples for laboratory examination
排除标准
- •HIV-1/2 infection
- •Symptomatic and asymptomatic malaria infection (presence of malaria parasites on thick blood smear)
- •Clinically significant acute or chronic illness at the time of randomization.
- •Any clinically relevant abnormality on history or examination
- •Use of immunosuppressive medication (other than inhaled or topical immunosuppressants)
- •Receipt of immunoglobulin within past 60 days
- •Abnormal laboratory values as specified below from blood collected within 42 days prior to randomization:
- •Haemoglobin <9.0 g/dL or <5.59 mmol/L
- •Absolute Neutrophil Count (ANC): < 1000/mm3 or < 1.0 x 109/L
- •Absolute Lymphocyte Count (ALC): ≤ 500/mm3 or ≤ 0.5 x 109/L
- •Platelets: ≤ 90,000 ≥ 550,000/mm3 or ≤ 90 x 109 ≥ 550 x 109/L
- •Creatinine: >
- •AST: >2.6 x ULN
- •ALT: >2.6 x ULN
- •Urinalysis: abnormal dipstick confirmed by microscopy
- •Protein 2+ or more
- •Blood 2+ or more (not due to menses)
- •History or evidence of autoimmune disease.
- •Positive for Hepatitis B surface antigen (HbsAg), positive for antibodies to Hepatitis C virus (HCV) or active syphilis.
- •Receipt of blood or blood products within the previous 6 months
- •History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
- •Prior or current participation in another investigational agent trial except to the EV06 trial
- •Current anti-tuberculosis (TB) prophylaxis or therapy
- •If female, currently pregnant (positive serum or urine pregnancy test), planning to get pregnant in the next 9 months or lactating
- •History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the volunteer's safety or interfere with the evaluation of the safety or immunogenicity of the vaccine
- •Volunteers will be enrolled regardless of schistosomiasis infection status. Volunteers with high S. mansoni egg count of >2000 eggs per gram of stool at screening will be treated before vaccination. Volunteers with low S mansoni egg count of <2000 eggs per gram of stool at screening will be asked to forgo treatment until after completion of week 24 visit of the trial. Volunteers with other helminth infections at screening will also receive treatment before vaccination.
研究组 & 干预措施
DNA-Protein
Co-administration of DNA-HIV-PT123 and AIDSVAX B/E at week 0, 4 and 24
干预措施: DNA-HIV-PT123 & AIDSVAX B/E (Biological)
结局指标
主要结局
Safety and tolerability of the late boost vaccination
时间窗: 4-week follow-up period after the late boost
Proportion of volunteers with adverse events
Vaccine induced binding antibody responses
时间窗: week 24
HIV-specific Env binding Antibody response
Safety and tolerability of the late boost
时间窗: Up to 24 weeks
Proportion of volunteers with serious adverse events
Vaccine induced neutralizing antibody responses
时间窗: week 24
Neutralizing antibody responses against tier 1 and tier 2 HIV-1 isolates
次要结局
- Ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced T-cell responses(Week 2, 12 and 24)