Table 2.
Inclusion criteria | Willing and able to give informed consent for participation in the study |
Aged between 18 and 55 years inclusive | |
In good health as determined by:
| |
Willing to use highly effective contraception from 1 month prior to receiving the first vaccine and for the duration of the study (females) | |
Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards | |
Willing to allow his or her general practitioner and/or consultant, if appropriate, to be notified of participation in the study | |
Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS) | |
Exclusion criteria | 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 investigations that are either unlikely to resolve or do not resolve on repeat testing | |
Prior history of receipt of an oral typhoid vaccine (eg, Ty21a) within the last 3 years or a paratyphoid vaccine (as part of a clinical trial) | |
Prior history of participation in a typhoid or paratyphoid controlled human infection study* | |
Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination | |
Plan to receive any vaccine other than the study vaccine within 4 weeks after any study vaccination (except for COVID-19 vaccines) | |
History of allergy or anaphylaxis to a previous vaccine or vaccine components | |
Receipt of immunoglobulin or any blood product transfusion within 3 months of study start | |
Participation in another research study involving an investigational product or that which may compromise the integrity of the study | |
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 50 kg 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:
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*Future studies in typhoid or paratyphoid endemic countries may consider including a history of S. Typhi or S. Paratyphi natural infection as an exclusion. This was not included in this study as the risk of prior natural infection was considered low.