Phase 1b Influenza Vaccine Study in Healthy Subjects

NCT01181336 | Completed Phase 1

• 1 other identifier: FLU-v-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.

Conditions

Influenza

Keywords

Safety; Tolerability; Immunogenicity; Influenza; Virus; Vaccine

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of FLU-v

  The safety and tolerability of two dose levels of FLU-v and the effect of the adjuvant on the safety and tolerability of FLU-v will be assessed by, Clinical signs and symptoms from physical exam and ECG; Adverse events (including local and systemic AEs); Laboratory safety (haematology, serum clinical chemistry, urinalysis); and Vital signs (blood pressure, heart rate, temperature, respiratory rate)

  Measurements will be taken at screening, then up to 21 days post-vaccination

Secondary Outcomes (1)

• Immunogenicity of FLU-v

  Measurements will be taken on Days 1 and 21 post-vaccination

Study Arms (5)

Group 2

EXPERIMENTAL

FLU-v Low Dose with adjuvant. FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects.

Biological: Influenza vaccine (FLU-v)

Group 3

EXPERIMENTAL

FLU-v High Dose with water for injection. FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects.

Biological: Influenza vaccine (FLU-v)

Group 4

EXPERIMENTAL

High Dose FLU-v with adjuvant FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects

Biological: Influenza vaccine (FLU-v)

Group 1

EXPERIMENTAL

FLU-v Low Dose with water for injection FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection 10 subjects

Biological: Influenza vaccine (FLU-v)

Control Group

PLACEBO COMPARATOR

Placebo with adjuvant (4 subjects) or Placebo without adjuvant (4 subjects)

Biological: FLU-v Control

Interventions

Influenza vaccine (FLU-v) BIOLOGICAL

Comparison of different dosages of FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection of (Low Dose / High Dose with adjuvant / water for injection)

Also known as: FLU-v

Group 1; Group 2; Group 3; Group 4

FLU-v Control BIOLOGICAL

Adjuvant only or water for injection only Administration: a single subcutaneous injection

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must have a BMI \>18.5 and ≤ 28.5 kg/m2.
• Subject must have no clinically significant abnormal findings, as judged by the Investigator, on the physical examination, ECG, medical history or clinical laboratory results during screening.
• Subject must be a non-user of tobacco products, or smoke ≤ 10 cigarettes per day (minimum 6 months prior to first dose).
• Subject must have a negative urine screen for drugs of abuse and a negative alcohol breath test at screening and check-in.
• Subject must refrain from consuming alcohol for 72 hours prior to each dose.
• Subject must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator.
• Subject must give voluntary written informed consent to participate in this trial.

You may not qualify if:

• Subject must not have previous influenza vaccination within the 12 months prior to test drug vaccination.
• Subject must not have had an influenza like illness within the 3 months prior to test drug vaccination.
• Subject must not have a history or presence of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder.
• Subject must not have an oral temperature \>38°C on day of vaccination (otherwise subject maybe be re-assigned to a subsequent cohort).
• Subject must not suffer from an inherited or acquired immunodeficiency.
• Subject must not suffer from a disease or be undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (\>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or non-steroidal anti-inflammatory drugs.
• Subject must not have a serologically positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Subject must not have a history of severe allergic reactions and/or anaphylaxis.
• Subject must not have any arm rash or tattoos which could confound the interpretation of any injection site reactions.
• Subject must not have participated in a previous clinical trial within 90 days prior to the first vaccination.
• Subject must not have donated blood or plasma more within 90 days prior to the first vaccination.
• Subject must not have donated bone marrow within 6 months prior to the first dose.
• Subject must not have received administration of immunoglobulins and/or any blood products within 90 days prior to the first vaccination, or any planned administration during the study period.
• Subject must not use any prescription medication within 14 days prior to the first vaccination.
• Subject must not use over-the-counter (OTC) medication 7 days prior to the first vaccination. Exceptions are described below under the heading 9.4.1.

Sponsors & Collaborators

• PepTcell Limited: lead

Study Sites (1)

Quintiles Drug Research Unit at Guy's Hospital

London, SE1 1YR, United Kingdom

Location

Related Publications (1)

• Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderley W. Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial. Vaccine. 2012 Jun 29;30(31):4655-60. doi: 10.1016/j.vaccine.2012.04.089. Epub 2012 May 8.

  PMID: 22575166 DERIVED

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Stuart Robinson, Dr

  PepTcell Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

GB (1)