Efficacy of a Meningococcal B Vaccine Against Neisseria Gonorrhoeae Infections Among Men Who Have Sex With Men: a Randomised-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Comparison between incidence of NG between two groups
研究概览
简要总结
Objectives: Efficacy of a meningococcal vaccine against Neisseria gonorrhoea (NG) infection among men who have sex with men (MSM).
Design: Parallel randomised double-blind placebo-controlled trial.
Setting: A teaching hospital in Hong Kong.
Participants: 150 adult MSM at risk of gonorrhoea infection (condomless sex with more than one man within the last six months, history of sexually transmitted infection [STI] diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria) would be recruited into the trial, with half allocated to intervention and control group each.
Intervention: Intervention and control group would receive, one month apart, two doses of meningococcal vaccine and normal saline, respectively.
Main outcome measures: Safety and efficacy of vaccine against gonorrhoea (time to first gonorrhoea infection and incidence), and behavioural change after vaccination.
Expected results: NG incidences in two groups would be compared. Efficacy of vaccine against gonorrhoea would be determined after controlling confounding variables. Characteristics of participants with incident NG would be distinguished from those without incident infections. Change of frequency of sexual activities and networking would be noted.
Implications: Strategies on STI screening and vaccination could be informed. Reduced STI burden post-vaccination could be measured with surveillance system.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Block randomisation would be used to generate the list of treatment groups with a block size of 4 in a centralised computer by a staff in the Research Centre unrelated to data analysis. Group assignment would be concealed and performed by another staff unrelated to data analysis who will pick the group number from the random allocation sequence in sequential order. The subjects and investigators would therefore be blinded.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male adult who has had sex with another male in the past six months
- •Ages 18 years or above
- •Normally resides in Hong Kong
- •Able to communicate in written and spoken Chinese or English
- •At risk of gonorrhoea infection (had condomless sex with more than one man within the last six months, history of STI diagnosis, inclination to have condomless sex, and other PrEP-eligible criteria)
- •Negative NG test result at the time of recruitment
- •No history of previous vaccination with MenB vaccines
- •Able and willing to attend all study visits
排除标准
- •Contraindications to receive MenB vaccine
- •Unable to give informed consent
研究组 & 干预措施
Intervention
Intramuscular injection of 2 doses of 0.5mL 4CMenB vaccine 1 month apart
干预措施: 4CMenB vaccine (Biological)
Control
Intramuscular injection of 2 doses of 0.5mL placebo 1 month apart
干预措施: Placebo (Other)
结局指标
主要结局
Comparison between incidence of NG between two groups
时间窗: Month 2 to Month 24
Difference in NG incidences in the two groups
次要结局
- Changes in risk behaviours and networking pattern after vaccination(Month 2 to Month 24)
- Safety profile of the vaccine(Month 2 to Month 24)
研究者
Tsz Ho Kwan
Research Assistant Professor
Chinese University of Hong Kong