A first-in-human study of ZH9/ZH9PA vaccine in healthy participants
Research type
Research Study
Full title
A Phase I, randomised, double-blind, placebo-controlled, parallel group dose escalation study to evaluate the safety, tolerability and immunogenicity of three doses of a potential oral enteric fever vaccine (ZH9 + ZH9PA) in healthy participants 18 to 45 years of age inclusive.
IRAS ID
266061
Contact name
Annelize Koch
Contact email
Sponsor organisation
Prokarium Ltd
Eudract number
2019-002047-22
Duration of Study in the UK
0 years, 11 months, 5 days
Research summary
The purpose of this study is to assess the safety, tolerability and activity of a new vaccine that has two components; ZH9 and ZH9PA. The study will investigate the effects of ZH9PA when given on its own at 2 different doses and when given in combination with ZH9 (Entervax). ZH9 and ZH9PA are being developed for the prevention of typhoid and paratyphoid fever. Both ZH9 and ZH9PA are based on the the same attenuated S. Typhi ZH9 chassis strain with ZH9PA modified to express antigens specific to S. Paratyphi A. ZH9 and ZH9PA are live bacteria that have genetically modified so that they cannot cause disease; they are genetically modified organisms. ZH9 has been given to humans previously.
Typhoid and paratyphoid fever are bacterial infections caused by the bacterium Salmonella Typhi and Salmonella Paratyphi A respectively. These infections are usually contracted following ingestion of food or drinking water which has been contaminated and therefore there is a prevalence of these diseases in less developed countries where sanitation and sewage treatment systems are poor.
There is currently a vaccine available for the prevention of typhoid fever but no vaccine available for paratyphoid fever. Therefore there is an unmet need to develop a vaccine which could effectively provide immunity for both typhoid and paratyphoid fever. ZH9 and ZH9PA are one such development.
ZH9 has already administered to 389 people and shown to be immunogenic. Therefore, this study will evaluate 2 dose levels of ZH9PA and then evaluate ZH9/ZH9PA in combination to determine if this could provide an effective combination vaccine.
The study will be conducted in 45 healthy participants, split into 3 groups (9,18,18 participants). Each group will receive the active study drug or matching placebo in a 2:1 ratio of active:placebo.
REC name
Wales REC 1
REC reference
19/WA/0177
Date of REC Opinion
19 Jul 2019
REC opinion
Further Information Favourable Opinion