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

ISRCTN	ISRCTN27362371
DOI	https://doi.org/10.1186/ISRCTN27362371
EudraCT/CTIS number	2007-000345-36
Secondary identifying numbers	SLA109

Submission date: 29/04/2008
Registration date: 15/05/2008
Last edited: 12/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Bell
Scientific

BioKinetic Europe, Ltd
14 Great Victoria Street
Belfast
BT2 7BA
United Kingdom

Study information

Study design	Parallel randomised controlled open-label single-centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Phase I open label study to evaluate the safety and immunogenicity of heat-labile toxin (LT) vaccination by transcutaneous immunisation (TCI) in the elderly and compare elderly immune responses with those developed by healthy adults
Study objectives	Enterotoxigenic Escherichia coli (ETEC) is known to be a primary cause of travellers' diarrhoea disease. ETEC organisms contain heat-labile toxin (LT), heat-stable toxin (ST) or both toxins. A vaccine based on LT has the potential to confer protection for subjects exposed to ETEC. The primary focus of this study is to evaluate the safety of the vaccine in the elderly population (greater than 65 years of age). This study will also compare the anti-heat-labile toxin (anti-LT) immune responses in healthy adults to the immune response in the elderly.
Ethics approval(s)	Office for Research Ethics Committee in Northern Ireland (ORECNI), 06/03/2007, ref: 07/NIR03/16
Health condition(s) or problem(s) studied	Enterotoxigenic Escherichia coli (ETEC) infection
Intervention	Open label, single centre study, enrolling 40 eligible subjects into either group 1 or group 2 in a 1:1 ratio to receive two treatments by transcutaneous immunisation, 21 days apart. Subjects will receive two doses of LT on a patch via transcutaneous immunisation at days 0 and 21. At the screening visit and on day 42, subjects will have clinical safety laboratory assessments including serum chemistry, haematology, and urinalysis to identify any laboratory abnormalities. On days 7 and 28, elderly subjects will have clinical safety laboratory assessments including serum chemistry, haematology, and urinalysis to identify any laboratory abnormalities. Serum will be collected at baseline (day 0), and on days 21 and 42 for all study subjects for enzyme-linked immunosorbent assay (ELISA) for anti-LT immunoglobulin G (IgG) and immunoglobulin A (IgA). Safety will be followed via diary cards and physician review.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Heat-labile toxin (LT) vaccination
Primary outcome measure	To evaluate the safety of two LT vaccinations following skin preparation with the split-path skewed (SPS) buffer in elderly volunteers. Primary outcome time points: Days 0, 7, 21, 28, 42, 201
Secondary outcome measures	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. Secondary outcome time points: Days 0, 21, 42
Overall study start date	04/04/2007
Completion date	19/02/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	40
Key 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)
Key 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
Date of first enrolment	04/04/2007
Date of final enrolment	19/02/2008

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

BioKinetic Europe, Ltd

Belfast
BT2 7BA
United Kingdom

Sponsor information

Iomai Corporation (USA)
Industry

c/o Sarah A. Frech, DVM, MPH
20 Firstfield Road
Suite 250
Gaithersburg
20878
United States of America

Website	http://www.iomai.com
"ROR"	https://ror.org/0144z1077

Funders

Funder type

Industry

Iomai Corporation (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

12/10/2016: No publications found in PubMed, verifying study status with principal investigator.