CTIS2023-507065-26-00
Active, not recruiting
Phase 1
A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal and intramuscular rabies vaccination < RABISKIMM >
Institute Of Tropical Medicine0 sites165 target enrollmentOctober 7, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rabies
- Sponsor
- Institute Of Tropical Medicine
- Enrollment
- 165
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •MAIN \+ PILOT \+ HEALTHY CONTROL GROUP: \>/\=18 to \=50 years of age, PILOT: should have had a completed or partly completed schedule of rabies vaccination more than one month prior to recruitment, PILOT: BMI \=30 kg/m2, PILOT: Able and willing to provide written informed consent, PILOT: No acute illness at time of recruitment, MAIN \+ PILOT: Willing to use contraception during the course of the trial (for women of childbearing potential), PILOT: Not pregnant or planning to become pregnant during the course of the trial, HEALTHY CONTROL GROUP: Able and willing to provide written informed consent, HEALTHY CONTROL GROUP: Agreement to share and discuss participant’s medical history and medical records when relevant, HEALTHY CONTROL GROUP: No acute illness at time of recruitment, MAIN: BMI \=30 kg/m2, MAIN: Agreement to refrain from blood donation and other vaccinations 30 days following each vaccination, MAIN: Agreement to share and discuss participant’s medical history and medical records when relevant, MAIN: Able and willing to provide written informed consent
Exclusion Criteria
- •MAIN \+ PILOT: Subjects who received a rabies vaccination prior to recruitment (including a single dose), MAIN \+ PILOT: Pregnancy or planning to become pregnant during the course of the trial, MAIN \+ PILOT \+ HEALTHY CONTROL GROUP: Subjects who received PEP (or immunoglobulines), MAIN \+ PILOT: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment, MAIN \+ PILOT: Active participation in another interventional clinical study with active substance intake during the trial or 1 month prior to recruitment, MAIN \+ PILOT: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short\-term oral steroids., MAIN \+ PILOT: Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed), MAIN \+ PILOT: History of anaphylaxis, allergic disease or reactions to any component of the study vaccines, HEALTHY CONTROL GROUP: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment., MAIN \+ PILOT : Tendency to keloid (scar) formation in response to skin damage, MAIN \+ PILOT \+ HEALTHY CONTROL GROUP: Skin diseases at the biopsy and vaccination site, MAIN \+ PILOT: History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture, MAIN \+ PILOT: Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data, HEALTHY CONTROL GROUP: Subjects who received a rabies vaccination prior to recruitment (including a single dose), HEALTHY CONTROL GROUP: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment, HEALTHY CONTROL GROUP: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short\-term oral steroids., HEALTHY CONTROL GROUP: Any other significant disease, disorder, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data, HEALTHY CONTROL GROUP: Suspected or known alcohol or drug dependency, MAIN \+ PILOT: Suspected or known alcohol or drug dependency
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
on-randomized clinical trial to compare the immunogenicity of revaccination with 23-valent pneumococcal polysaccharide vaccine between healthy elderly and those with diabetes in KoreaEndocrine, nutritional and metabolic diseaseKCT0005125MSD Korea254
Not yet recruiting
Phase 4
A randomized control trial comparing the antibodies to COVID-19 vaccine between kidney transplant recipients who continue on immunosuppressive regimen of tacrolimus and mycophenolic acid and recipients who switch to mTOR inhibitor with low dose tacrolimus two weeks before vaccinatioTCTR20220404001Division of nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University40
Completed
Phase 4
To compare two drugs dexmedetomidine and midazolam as premedication in children undergoing corrective surgery for congenital heart disease .Health Condition 1: null- Congenital heart diseaseHealth Condition 2: Q249- Congenital malformation of heart,unspecifiedCTRI/2018/01/011297Armed forces medical college90
Completed
Not Applicable
A randomised controlled trial of prophylactic versus no prophylactic platelet transfusions in patients with haematological malignanciesHaematological malignanciesBlood - Haematological diseasesCancer - Other cancer typesACTRN12609001087246ational Health Service Blood & Transplant600
Recruiting
Not Applicable
A clinical interventional study to compare the efficacy of two combined non invasive brain stimulation as motor enhancement therapy for upper extremity in brain attack due to blocked blood vessel cases of more than six months.Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteriesCTRI/2019/11/022009JIPMER