Gene Expression Profiles in Muscle After Immunisation

Healthy Clinical Trial

Official title:

Clinical Study to Generate Exploratory Training Set of Data on the Time Course of Gene Expression Profile at Site of Antigen Deposition Compared With Whole Blood Following IM Injection With Alum or MF59-adjuvanted Protein Subunit Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368327
• Other study ID #: CRC305E
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: August 7, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: February 2015
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This clinical study is part of the BIOVACSAFE project which is funded by the Innovative Medicine Initiative. In this study we will take a small muscle biopsy in order to identify any differences in the response around the actual site of injection compared with responses we measure in blood at the same time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. The participant is able to read and understand the Informed Consent Form (ICF), and understand study procedures.

2. The participant has signed the ICF.

3. Healthy male participants aged 18-45 years inclusive.

4. BMI between 19-27 kg/m2.

5. Pre-immunised with Hepatitis B vaccine

6. Hepatitis B sAb positive (evidence of vaccine-induced immunity)

7. Hepatitis B sAg and cAb negative (evidence of lack of prior/current HBV infection)

8. Hepatitis C and HIV seronegative.

9. Available for follow-up for the duration of the study.

10. Agree to abstain from donating blood during the study.

11. The participant is, in the opinion of the investigator, healthy on the basis of a, medical history, a symptom directed medical examination and vital signs.

Exclusion Criteria:

1. History of hypersensitivity to any of the vaccine components or a history of any allergy that in the opinion of the investigator would contraindicate participant participation

2. Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician.

3. Known immune or coagulation disorder or clinically significant abnormalities of platelets, Hb or coagulation on screening labs

4. Known allergy to injected local anaesthetics

5. Unwilling to undergo muscle biopsies

6. Use of steroids or immunosuppressive/immunomodulating drugs either orally or parenterally within 3 months of visit 1.

7. Currently participating in a clinical trial with an investigational or non- investigational drug or device, or has participated in another clinical trial within the 3 months preceding the study.

8. Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.

9. Receipt of blood products or immunoglobin, within 3 months of visit 1.

10. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Fluad

• Fendrix

• Placebo

Locations

Country	Name	City	State
United Kingdom	Surrey Clinical Research Centre	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	Max Planck Institute for Infection Biology

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline values of gene expression in whole blood and muscle		Day 0, Day 0+3 hours, Day 1, Day 3, Day 5 and Day 7	No