Typhoid fever is a life-threatening infection caused by the bacterium Salmonella Typhi. It is typically spread through contaminated water or food and is more common in areas with poor sanitation and limited access to safe drinking water. In 2019, an estimated 9 million people globally were infected with typhoid fever every year, and approximately 110,000 people died from the disease annually. Typhoid fever can significantly affect people's lives by causing symptoms such as fever, fatigue, headaches, nausea, abdominal pain, constipation, or diarrhoea, which can interfere with daily activities and may lead to serious complications if left untreated.
Vaccination is essential to protect individuals and communities, particularly when travelling to typhoid-endemic countries. However, current vaccines are typically administered using syringes and needles, which can require trained healthcare workers, require specific storage conditions, create a risk of needle-stick injuries, and may discourage people with needle fear or anxiety from being vaccinated. New research is needed to investigate alternative vaccine delivery methods that may overcome these limitations.
This trial tests delivery of a potential Typhoid Conjugate Vaccine (TCV) using a high-density microarray platform (HD-MAP), a needle-free vaccine delivery device. The HD-MAP could offer advantages such as easier transport and storage, reduced reliance on trained healthcare workers, elimination of sharps, and improved accessibility for people with needle fear or anxiety.
The needle-free typhoid vaccine trial is evaluating a single dose of a potential Typhoid Conjugate Vaccine (TCV) delivered via a high-density microarray platform (HD-MAP). This device will be applied to the participant's non-dominant upper arm.
Participants will receive 3 doses of either the investigational vaccine or a placebo on Day 1, with an 80% chance of receiving the investigational vaccine. Following dosing, participants will remain at the clinic for approximately one hour for safety monitoring by the medical team.
Follow-up assessments will include a phone call on Day 2 and clinic visits on Days 4, 8, 14, 29, and 57. All procedures will be explained clearly, and participants can ask questions at any time.
