Heat-labile toxin (LT) safety study in the elderly

Phase 1

Completed

• Conditions: Enterotoxigenic Escherichia coli (ETEC) infection; Infections and Infestations; Other bacterial intestinal infections

• Registration Number: ISRCTN27362371
• Lead Sponsor: Iomai Corporation (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-15
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Healthy elderly (greater than or equal to 65 years of age) or adult (18 - 40 years of age) males and females
2. Signed informed consent
3. Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours prior to each vaccination with understanding (through the informed consent process) to not become pregnant through the end of the study. Also, they must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom, diaphragm with spermicide), and intra-uterine device (IUD)

Exclusion Criteria

1. Laboratory abnormalities (as determined by the toxicity grading scale [grade 1 - 4]) at laboratory screening
2. Abnormalities at physical examination (as determined by the toxicity grading scale [grade 1 - 4])
3. Known allergies to any component of the vaccine
4. Known disturbance of coagulation
5. Known allergies to adhesives
6. Participated in unrelated research involving investigational product within 90 days before planned date of first vaccination
7. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
8. Ever received cholera toxin or vaccine (e.g. Orochol®, Dukoral®)
9. Medical history of acute or chronic skin disease at vaccination site(s)
10. Active skin allergy
11. Recent or regular use of oral or injected steroid medications within 30 days prior to first vaccination
12. Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination
13. Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the investigator
14. Positive serology for human immunodeficiency virus-1 (HIV-1), human immunodeficiency virus-2 (HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
15. History of severe atopy
16. Signs or history of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, history of keloid formation, or active contact dermatitis
17. Artificial tanning (ultraviolet [UV] radiation) or use of artificial/spray tan products over the duration of the study including the screening period
18. Hirsute (significant amount of hair) at vaccination area(s)
19. Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatological monitoring of the vaccination site(s)
20. Fever equal to or greater than 38.0°C (greater than or equal to 100.4°F) at the time of planned vaccination
21. Suspicion of or recent history of alcohol or substance abuse within one year of planned vaccination
22. Donated blood or blood products such as plasma within the past 90 days
23. Women who are pregnant or breastfeeding
24. Employee of the investigational site
25. Medical history of achlohydria
26. History of abdominal surgery (excluding caesarean section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent, acute gastrointestinal problems

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of two LT vaccinations following skin preparation with the split-path skewed (SPS) buffer in elderly volunteers.<br><br>Primary outcome time points: Days 0, 7, 21, 28, 42, 201

Secondary Outcome Measures

Name	Time	Method
To evaluate the immune responses achieved by two LT vaccinations following skin preparation with the SPS buffer in elderly volunteers and to compare those responses with those of healthy adult volunteers.<br><br>Secondary outcome time points: Days 0, 21, 42