An Open Label, Phase 2 Study to Evaluate the Safety and Immunogenicity of an Ad26.ZEBOV Booster Dose in Human Immunodeficiency Virus Positive (HIV+) Adults Previously Vaccinated With the Ad26.ZEBOV, MVA-BN-Filo Vaccine Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Incidence of solicited adverse events
研究概览
简要总结
This is an open label study to evaluate the safety and immune response to a booster dose of Ad26.ZEBOV Ebola vaccine in HIV+ adults from Kenya and Uganda. Only participants who have received the 2-dose Ebola vaccine regimen "Ad26.ZEBOV/MVA-BN-Filo " in the VAC52150EBL2002 vaccine trial about 4 years ago are eligible to take part.
Approximately 50 healthy HIV+ adults, aged 18 - 50 years at the time of the parent trial, will be invited. Participants will first be asked to provide consent to participate in this study. Upon receiving the booster vaccination, participants will be followed up for approximately 28 days (+/- 3 days) to collect information on side effects and provide blood samples for antibody measurement.
This study is designed to provide descriptive information regarding vaccine safety and immunogenicity. There is no formal treatment comparisons and no formal testing of statistical hypothesis.
详细描述
TITLE
An open label, Phase 2 study to evaluate the safety and immunogenicity of an Ad26.ZEBOV booster dose in Human Immunodeficiency Virus positive (HIV+) adults previously vaccinated with the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.
RATIONALE
In previous Phase 2 and 3 trials, HIV+ adult participants were vaccinated with a 2-dose Ebola vaccine regimen of adenovirus serotype 26 expressing the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) followed by Modified Vaccinia Ankara Bavarian Nordic vector expressing multiple filovirus proteins (MVA-BN-Filo). This Ebola vaccine regimen elicited humoral immune responses in HIV+ adults comparable to those in HIV-negative adults 21-days after dose 2. However, the durability of vaccine-induced humoral responses was not known.
PRIMARY OBJECTIVES
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have previously received the 2-dose Ebola vaccine regimen in Kenya or Uganda in Cohort 2a of the VAC52150EBL2002 study.
- •Must be aged 18 - 50 years at time of randomisation in the VAC52150EBL2002 study.
- •Must consent to participate in the study by signing or thumbprinting an informed consent form (ICF), indicating that the participant understands the purpose and procedures of the study, as well as the potential risks and benefits of participation.
- •Must be willing/able to ensure that participants adhere to the prohibitions and restrictions specified in this protocol
- •Must be available and willing to participate for the duration of the study visits.
- •Must be in reasonably good medical condition (absence of acquired immunodeficiency syndrome [AIDS]-defining illnesses or clinically significant disease)
- •Must be on a stable regimen of HAART, with a HIV viral load of <50 copies/mL and a CD4+ T-cell count of >350 cells/µL at screening. Must be willing to continue HAART throughout the study.
- •Potential participants must be healthy on the basis of clinical laboratory tests performed at screening.
- •Female subjects of childbearing potential must use adequate birth control measures consistent with local regulations, from at least 14 days before vaccination until the end of the study. Must have a negative pregnancy test at screening and immediately prior to vaccination.
- •Must have a means to be contacted
排除标准
- •Participants in the VAC52150EBL2002 trial who were not in the Cohort 2a, or were allocated to the placebo arm.
- •Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, chicken or egg proteins and aminoglycosides (e.g. gentamicin).
- •Presence of acute illness or axillary temperature ≥38ºC on the day of vaccination. Participants with such symptoms will be deferred.
- •Women who are breast-feeding or known to be pregnant or planning to become pregnant during the study.
- •Clinically significant history of skin disorder, allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
- •Received a blood transfusion or other blood products within 8 weeks of enrolment.
- •Potential participants who have been vaccinated with live-attenuated vaccines within 30 days before and after the study vaccination, and with inactive vaccine within 15 days before and after the study vaccination.
- •Receipt of any disallowed therapies before the planned administration of the study vaccine.
- •Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study or are unlikely to complete the study.
- •Any other finding which, in the opinion of the investigator, would increase the risk of an adverse outcome.
结局指标
主要结局
Incidence of solicited adverse events
时间窗: From the day of the booster to 7 days post-booster vaccination
Number and percentage of participants with solicited adverse events at the local injection site and systemically
Vaccine-induced humoral immune responses to the Ebola virus glycoprotein (EBOV GP)
时间窗: At Day 22
EBOV GP antibody concentration measured by FANG ELISA in ELISA Units (EU) per mL.
Incidence of unsolicited adverse events
时间窗: From the day of the booster to 28 days post-booster vaccination
Number and percentage of participants with any untoward medical event
次要结局
未报告次要终点