BiVISTA - Bivalent Vaccination against Salmonella Typhi and Paratyphi A
Research type
Research Study
Full title
A Phase II, Multicentre, Double-blind, Randomised, Controlled Study of a Bivalent Conjugate Vaccine against Salmonella enterica serovar Typhi and Paratyphi A to evaluate the Efficacy, Immunogenicity and Safety using a Human Challenge Model of Paratyphoid A Infection
IRAS ID
1007772
Contact name
Andrew Pollard
Contact email
Sponsor organisation
Research Governance, Ethics and Assurance (RGEA), University of Oxford
ISRCTN Number
ISRCTN65855590
Research summary
Typhoid and Paratyphoid fever are forms of an illness called enteric fever. Their names come from the bacteria that cause them: Salmonella Typhi (typhoid) and Salmonella Paratyphi (paratyphoid, mostly caused by S. Paratyphi A). Enteric fever can cause high temperatures, headache, muscle and joint aches, abdominal pain, constipation and feeling generally unwell. If severe or left untreated, it can result in complications, including long-term carriage of the bacteria or even death.
There are approximately 13 million cases of enteric fever every year, with 3.8 million of these due to paratyphoid infection. It spreads by the faeces of an infected person, typically through contaminated water or food. It is prevalent in regions of the world where people have inadequate access to clean water and sanitation.
Effective vaccines against S. Typhi already exist, but there are no licensed vaccines against S. Paratyphi A. The Serum Institute of India (SII) has developed a vaccine targeting both Salmonella Typhi and Salmonella Paratyphi A, the SII-TCV(B), given as an injection in the upper arm muscle. It was tested in humans, showing it is safe. In this study, we will test if this vaccine: 1. could prevent paratyphoid A, using a controlled human infection model (CHIM), and 2. induces similar response as a comparator vaccine (a licensed vaccine against S. Typhi). We will also use this study to better understand how we develop protection against paratyphoid A.
In this CHIM, participants are given a vaccine [SII-TCV(B) or comparator], later they are given a dose of S. Paratyphi A which can cause disease. They are closely monitored and treated 14 days after drinking the bacteria, or sooner, if they become unwell. This model of studying vaccines has been safely undertaken by participants in previous Oxford Vaccine Group studies, and it was recommended by the World Health Organisation (WHO) to study the efficacy of a paratyphoid A vaccine candidate.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0309
Date of REC Opinion
28 Nov 2024
REC opinion
Further Information Favourable Opinion