NCT01509144已完成1 期
Phase 1, Randomised, Single-centre, Observer-blind Clinical Trial of Safety and Immunogenicity of Nasal-prime and Intramuscular Boost Immunisation With EN41-FPA2 HIV Vaccine in Healthy Female Volunteers
PX'Therapeutics2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- • Safety of 5 EN41-FPA2 immunisations Primary Endpoints: AEs and IgG and IgA responses to EN41-FPA2
研究概览
简要总结
Objectives:
- To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route
- To assess immunogenicity responses induced by the vaccine.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 18 and 55 years on the day of screening
- •Available for a maximal study duration of 12/13 months from the inclusion
- •Willing and able to give written informed consent
- •At low risk of HIV infection and willing to remain so for the duration of the study defined as:
- •no history of injecting drug use in the previous ten years
- •no gonorrhoea or syphilis in the last six months
- •no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
- •no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
- •no unprotected vaginal intercourse in the last six months outside a relationship with a regular known HIV negative partner
- •not had unprotected sex with someone from a region where HIV is more common (e.g Sub-Saharan African, Caribbean, South East Asia) outside a relationship with a regular known HIV negative partner
- •Negative HIV 1/2 antibody/antigen test at screening
- •If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; use of condoms incorporating spermicide if using these; physiological or anatomical sterility) from 14 days prior to the first vaccination until 6 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination and blood pregnancy test at screening and final follow up.
- •Agree, to abstain from medications or other agents that are applied via the nasal route from 24 hours prior to each nasal vaccine dosing through to the safety assessment 1week later
- •Agree to abstain from donating blood during their participation in the trial
- •Registered with GP and medical history available for 12 months before dosing
- •Satisfactory response received from General Practitioner relating to medical history before randomization.
排除标准
- •Pregnant or lactating, or planning to get pregnant within the next year
- •Positive alcohol test
- •Positive drugs of abuse test
- •Clinically relevant abnormality on history or examination:
- •central nervous system disorder or disease, including
- •history of grand-mal epilepsy
- •cranial nerve palsies
- •severe eczema
- •severe epistaxis requiring surgical intervention or blood transfusion
- •clinically significant liver disease
- •clinically significant haematological, metabolic, gastrointestinal, renal, psychiatric or cardio-pulmonary disorders
- •ongoing infection;
- •autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
- •using inhaled cortico-steroids and intranasal medications
- •Known or suspected history of clinically relevant nasal surgery, injury, nasal polyps or cleft palate, or a condition likely to require regular intranasal medication, which in the opinion of the investigator might interfere with intranasal vaccine administration
- •Known hypersensitivity to any component of the vaccine formulations used in this trial or have severe or multiple allergies
- •History of severe local or general reaction to vaccination defined as
- •local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
- •general: fever > 39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- •Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of scheduled study vaccine dosing
- •Receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
- •Receipt of blood products or immunoglobin within 4 months of screening
- •Participation in another trial of a medicinal product, completed less than 90 days prior to Visit 2 and planned participation in another clinical trial during the present trial
- •HIV 1/2 antibody/antigen positive or indeterminate on screening
- •Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- •Clinically significant routine laboratory parameters.
- •Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
- •Unlikely to comply with protocol
- •History of drug or alcohol abuse or regular using of drugs, or who test positive in drugs of abuse and alcohol test at screening or admission
- •Has a condition, or is on regular medication (other than paracetamol, multivitamin, E45, or over the counter remedies) which in the opinion of the investigator is not suitable for participation in the study
- •Any local vaginal, cervical or gynaecological condition which may interfere with collection or interpretation of data collected through vaginal samples.
- •Using any Intra Uterine Contraceptive Device; as there is a risk of dislodging, displacing or removing the device when pulling or removing Softcup used for vaginal sampling.
- •Clinically significant abnormality on ECG performed at the screening visit
- •Any condition that, in the investigator's opinion, compromises the volunteer's ability to meet protocol requirements or to complete the study.
结局指标
主要结局
• Safety of 5 EN41-FPA2 immunisations Primary Endpoints: AEs and IgG and IgA responses to EN41-FPA2
时间窗: up to 28 days after the final immunisation
•Safety - Grade 3 or above adverse event. Any grade of adverse event that results in a clinical decision to discontinue further immunisations - Any grade of adverse event that occurs in a volunteer that has received at least one immunisation • Immunogenicity: Proportion of individuals mounting a serum IgG response to EN41-FPA2 at any time point up to 28 days after the final immunisation with 3 fold increase from pre-immunisation baseline sample taken at visit 2, week 0, priming #1. If no serum sample is available at this time point, serum taken at visit 1, screening may be substituted."
次要结局
未报告次要终点
研究者
研究点 (2)
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