Be Part of Research - Trial Details - Salmonella vaccine study in Oxford

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Nontyphoidal Salmonellae are bacteria that can cause gut infections resulting in diarrhoea, both in the UK and globally. However, under some circumstances, these bacteria can cause a more severe illness where the infection spreads beyond the gut into the bloodstream, a condition termed invasive non-typhoidal Salmonellosis (iNTS). iNTS disease is an under-recognised cause of disease and death in Sub Saharan Africa. In these regions, it primarily occurs in young children, particularly those with malaria and malnutrition. High death rates, difficulties in diagnosing this infection in the developing world, increasing resistance of the bacteria to common antibiotics, and spread via contaminated food and water make the development of an effective and affordable vaccine against iNTS an essential control measure.
A new and innovative vaccine (iNTS-GMMA) has been developed which is based on the formation of bacterial outer surface particles. This vaccine facilitates exposure of components of the bacteria to the human immune system without the risk of causing infection. Developed by GSK Biologicals and GSK Vaccines Institute for Global health (GVGH), the aim of this vaccine is to confer immune protection to the most common African strains of the bacteria causing iNTS disease.

Healthy volunteers aged between 18 and 55 years

You can take part if:

You may not be able to take part if:

Current exclusion criteria as of 14/09/2022:

The participant may not enter the study if any of the following apply:1. History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators. This includes any history of significant disease in the following:1.2. Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death1.3. Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease1.4. Endocrine disorders such as diabetes mellitus and Addison’s disease1.5. Significant renal or bladder disease1.6. Biliary tract disease1.7. Gastro-intestinal disease such as inflammatory bowel disease, abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)1.8. Neurological disease such as seizures and myasthenia gravis1.9. Haematological disease including coagulation problems1.10. Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency1.11. Psychiatric illness requiring hospitalisation1.12. Depression, anxiety or other psychiatric illness whose severity is deemed clinically significant by the study investigators1.13. Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)1.14. Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ2. Have any known or suspected impairment or alteration of immune function, resulting from, for example: 2.1. Congenital or acquired immunodeficiency (including IgA deficiency)2.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition2.3. Autoimmune disease2.4. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months).3. Study significant abnormalities on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study4. Have received any oral typhoid vaccination (e.g. Ty21a or M01ZH09) within the last 3 years or a paratyphoid vaccine (as part of a clinical trial)5. Have participated in previous typhoid or paratyphoid challenge studies (with ingestion of challenge agent).6. Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination7. Plan to receive any vaccine other than the study vaccine within 4 weeks after any study vaccination (COVID-19 vaccine exempt, see Section 9.14)8. Any history of allergy or anaphylaxis to a previous vaccine or vaccine component9. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start 10. Participation in another research study involving an investigational product or that which may compromise the integrity of the study (e.g. significant volumes of blood already taken in previous study) in the past 12 weeks, or are planning to do so within the trial period11. Planned donation of blood/blood products outside of the study and during the trial period12. Inability, in the opinion of the Investigator, to comply with all study requirements including likelihood of successful venepuncture during the trial13. Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study14. Weight less than 50kg or a BMI < 18.4 kg/m2 or a BMI > 40 kg/m215. Any other significant disease or disorder which, in the opinion of the Investigator, may: 15.1. Put the participants at risk because of participation in the study15.2. Influence the result of the study15.3 Impair the participant’s ability to participate in the study

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Previous exclusion criteria:

1. History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators. This includes any history of significant disease in the following:1.1. Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death1.2. Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease1.3. Endocrine disorders such as diabetes mellitus and Addison’s disease1.4. Significant renal or bladder disease1.5. Biliary tract disease1.6. Gastro-intestinal disease such as inflammatory bowel disease, abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)1.7. Neurological disease such as seizures and myasthenia gravis1.8. Haematological disease including coagulation problems1.9. Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency1.10. Psychiatric illness requiring hospitalisation1.11. Depression, anxiety or other psychiatric illness whose severity is deemed clinically significant by the study investigators1.12. Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)1.13. Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ2. Have any known or suspected impairment or alteration of immune function, resulting from, for example: 2.1. Congenital or acquired immunodeficiency (including IgA deficiency)2.2. Human Immunodeficiency Virus (HIV) infection or symptoms/signs suggestive of an HIV-associated condition2.3. Autoimmune disease2.4. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (including for more than 7 days consecutively within the previous 3 months).3. Study significant abnormalities on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study4. Prior history of receipt of a typhoid vaccine (e.g. Ty21a, M01ZH09) or a paratyphoid vaccine (as part of a clinical trial)5. Prior history of participation in a Typhoid or Paratyphoid controlled human infection study6. Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination7. Plan to receive any vaccine other than the study vaccine within 4 weeks after any study vaccination (COVID-19 vaccine exempt, see Section 9.14)8. Any history of allergy or anaphylaxis to a previous vaccine or vaccine component9. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start 10. Participation in another research study involving an investigational product or that which may compromise the integrity of the study (e.g. significant volumes of blood already taken in the previous study) in the past 12 weeks, or are planning to do so within the trial period11. Planned donation of blood/blood products outside of the study and during the trial period.12. Inability, in the opinion of the Investigator, to comply with all study requirements including the likelihood of successful venepuncture during the trial13. Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study14. Weight less than 50 kg or a BMI < 18.4 kg/m² or a BMI > 40 kg/m²15. Any other significant disease or disorder which, in the opinion of the Investigator, may: 15.1. Put the participants at risk because of participation in the study15.2. Influence the result of the study15.3. Impair the participant’s ability to participate in the study

TEMPORARY EXCLUSION CRITERIA (Please see protocol for further details).

There are no specific benefits of taking part in this study. However, volunteers would be taking part in the knowledge that they have played a part in the early stages of developing a new vaccine against a bacteria that causes a significant burden of death and disease, particularly in sub-Saharan Africa and in children under 5 years of age for which there is currently no licensed vaccine.
Intra-muscular vaccination commonly causes a transient and self-limiting local inflammatory reaction. This may typically include discomfort, redness and swelling, and some volunteers may feel generally unwell in themselves for a short time. Anaphylaxis is a rare but a potentially life-threatening allergic reaction and may occur (very rarely) after immunisation. All clinical staff are trained in the immediate treatment of anaphylactic reactions including the use of intramuscular adrenaline. Participants will be monitored for at least 1 hour after each vaccine dose is given. This study is the first time that iNTS-GMMA vaccine will be given to human participants, therefore it is not known for certain how participants will react to the vaccine. The pre-clinical studies of the vaccine have shown good safety results. In addition, GMMA-based vaccines against other bacteria have been safely used in over 100 people. However, this is a new vaccine and there may be side effects that are not currently known. The safety of the participants in all groups will be monitored following vaccination. This will be done by reviewing symptoms at visits and through the electronic Diary (eDiary). Participants will receive a card with study contact information and are advised to keep this card with them at all times during the study. Other medical staff can then contact the study doctor or nurse if needed to ask about the vaccine or product the participant has received. Participants will have access to a study doctor 24 hours a day until the end of the study. The researchers will emphasise participants staying in regular contact with the team. Blood tests can be painful and sometimes leave bruising or temporary discomfort, but these all resolve in a very short period of time. Rarely fainting can occur. Oral fluid samples are collected with a mouth swab and do not cause any discomfort. Stool sample collection is opt-in only and is a straightforward procedure. For females, if they became pregnant during the study would need to be withdrawn and undergo regular follow up during their pregnancy. This is standard practice because there is no data on the safety of this vaccine in pregnancy. Female participants will undergo pregnancy tests at screen and each subsequent vaccine and are advised on contraception during the study period.

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