PACTR202310834458532尚未招募1 期
A Phase 1 Clinical Study to Evaluate the Safety and Immunogenicity of a Novel GMMA Vaccine Against Invasive Non-Typhoidal Salmonella in healthy Kenyan adults.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Written or witnessed/thumb printed informed consent obtained from the participant.
- •Aged between 18 – 45 years
- •In good health as determined by study clinician by: Medical history, Physical examination and heamatology and biochemistry laboratory assessments and Clinical judgement of the investigators
- •Participants satisfying all screening requirements.
- •Participants seronegative for HIV, hepatitis B, and hepatitis C.
- •Females willing to use effective contraception and should be on contraception for at least one month prior to receiving the first vaccine and for the duration of the study.
- •Able to attend the scheduled visits and to comply with all study procedures
排除标准
- •History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators.
- •Have any known or suspected impairment or alteration of immune function
- •Study significant abnormalities on screening that are either unlikely to resolve or do not resolve on repeat testing
- •Known exposure to non typhoidal Salmonella during lifetime of the subject participant as documented by patient records (e.g., history of microbiologically-confirmed NTS infection)
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study.
- •Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
- •Prior receipt of a typhoid vaccine or the Shigella GMMA vaccine.
- •Plan to receive any vaccine other than the study vaccine within 4 weeks after vaccination. COVID19 vaccines are an exception.
- •Scheduled procedures requiring general anaesthesia during the study
- •Participant who is terminally ill
- •Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
- •Participation in another clinical research study involving an investigational product or a non-investigational intervention (drug or invasive medical device) in the past 12 weeks, or are planning to do so at any point within the trial period
- •Inability, in the opinion of the Investigator, to comply with all study requirements including likelihood of successful venepuncture during the trial
- •Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study
- •Weight less than 45kg or a BMI < 18.4 kg/m2 or a BMI > 40 kg/m2
- •Any other significant disease or disorder which, in the opinion of the Investigator, may:
- •Put the participants at risk because of participation in the study
- •Influence the result of the study
- •Impair the participant’s ability to participate in the study
研究者
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