A placebo controlled single-blind single-dose study to determine the immunogenicity and safety of freeze dried M01ZH09 typhoid vaccine in healthy adult volunteers from Viet Nam

Completed

• Conditions: Typhoid Fever; Infections and Infestations; Intestinal infectious diseases

• Registration Number: ISRCTN45854377
• Lead Sponsor: Emergent Europe Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

Subjects must satisfy the following criteria:
1. Healthy adult volunteers aged 19 to 30 years inclusive of Vietnamese origin, who are able and willing to give written informed consent, following a detailed explanation of participation in the study
2. Volunteers who will be available for the duration of the study and available for scheduled and potential additional visits

Exclusion Criteria

1. Any clinically significant medical or psychiatric condition or clinically significant abnormal serum biochemistry or haematology results that, in opinion of the Investigator, preclude participation in the study
2. Female subjects who are pregnant (confirmed with urinary pregnancy test) or breast-feeding, or of childbearing potential and unwilling to use a reliable method of contraception (oral contraceptives or barrier method with spermicidal preparation) throughout the study period
3. Have known hypersensitivity to ciprofloxacin and trimethoprim sulphamethoxazole or used antibiotics/antibacterials within 14 days prior to administration of study medication
4. Have known hypersensitivity to any component of the vaccine or buffer solution used in this study, including subjects with phenylketonuria or have experience anaphylactic shock after vaccination
5. Have received any vaccine against S. typhi whether licensed or investigational, in the last ten years, or who have ever suffered from typhoid fever
6. Work as commercial food handlers
7. Direct contact with groups at risk of infections (e.g. patients in special care units, immuno-compromised individuals, pregnant women, children less than two years of age and individuals more than 70 years)
8. Have a positive bacterial culture of their faecal sample obtained at the screening visit, for any Salmonella species
9. A known impairment of immune function including Acquired Immune Deficiency Syndrome (AIDS) or those receiving (or have received in the six months prior to study entry) cytotoxic drugs immunosuppressive therapy (including systemic corticosteroids) or have an Immunoglobulin A (IgA) deficiency
10. Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C positive
11. A significant acute febrile illness (fever of 38.0°C or more) at time of dosing
12. Chronic diseases: this will include all autoimmune and immuno-compromising conditions and any other chronic condition, which at the judgement of the investigator, may put the subject at higher risk of side effects from the study vaccine. Conditions in the latter category might include:
a. unexplained anaemia
b. hepato-biliary disease
c. uncontrolled hypertension
d. subjects with prosthetic joints or heart valves, etc.,
13. A current problem, based on history, with substance abuse or with a history of substance abuse that, in the opinion of the investigator, might interfere with participation in the study including inability to refrain from smoking for 48 hours
14. Are currently involved in a clinical study, have taken an investigational drug or have received investigational or licensed vaccines in the preceding four weeks from screening or anticipate receiving a vaccine other than study medication during the first four weeks, post vaccination, of the study
15. A known or suspected history of liver or active gall bladder disease
16. Use antacids, proton pump inhibitors or H2 blockers on a regular basis or have consumed proton pump inhibitors or H2 blockers within 24 hours prior to dosing
17. Subjects excluded for medical reasons will be referred to appropriate medical care services or counselling

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjects were considered to have had an immune response if they achieved a day seven result of more than or equal to four Antibody-Secreting Cells (ASCs) per 10^6 Peripheral Blood Mononuclear Cells (PBMC), secreting Immunoglobulin A (IgA) specific for S. typhi LipoPolySaccharide (LPS) detected by Enzyme-Linked Immunosorbent Spot (ELISPOT) assay, (assuming a day zero result of less than four ASCs per 10^6 PBMC), and/or undergo seroconversion for serum Immunoglobulin G (IgG) to LPS. <br><br>Seroconversion for serum IgG to LPS is defined as a four-fold or greater increase in the serum IgG antibody on serial dilution by Enzyme- Linked Immunosorbant Assay (ELISA), to S. typhi LPS between day zero and day 28.

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures