Immunogenicity of Adjuvanted or Non-adjuvanted H5N1 Booster Vaccine in Adults Primed to A/VN/1194/04

NCT00814385 | Completed Phase 1 DMC

• 1 other identifier: UHL10492
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 2

Brief Summary

This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Geometric mean antibody titres to influenza H5N1 by neutralising antibody, HI and SRH

  pre vaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks, 56 weeks

Secondary Outcomes (2)

• local and systemic reactogenicity

  within 7 days of each vaccination

• Seroprotective and seroconversion responses to H5N1 by neutralising antibody, HI and SRH

  Prevaccination, 3 weeks, 6 weeks, 52 weeks, 55 weeks and 56 weeks

Study Arms (9)

Vaccine arm 1

ACTIVE COMPARATOR

Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks

Biological: Aflunov (Single prime, single boost)

Vaccine arm 2

ACTIVE COMPARATOR

Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks

Biological: Aflunov (Single prime, single boost)

Vaccine arm 3

ACTIVE COMPARATOR

Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks

Biological: Aflunov (single prime, single boost)

Vaccine arm 4

ACTIVE COMPARATOR

Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin, given as single dose followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks

Biological: Aflunov (single prime, single boost)

Vaccine arm 5

ACTIVE COMPARATOR

Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks

Biological: Aflunov (Double prime, single boost)

vaccine arm 6

ACTIVE COMPARATOR

Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 3.75microg dose at 52 weeks

Biological: Aflunov (double prime, single boost)

Vaccine arm 7

ACTIVE COMPARATOR

Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by non-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks

Biological: Aflunov (double prime, single boost)

Vaccine arm 8

ACTIVE COMPARATOR

Two doses of Mf59-adjuvanted A/VN/1194/04 H5N1 vaccine containing 7.5microg haemagglutinin followed by MF59-adjuvanted H5N1 clade 2 vaccine containing 7.5microg dose at 52 weeks

Biological: Aflunov (double prime, single boost)

Vaccine arm 9

ACTIVE COMPARATOR

No priming dose and single dose MF59 adjuvanted H5N1 vaccine at 52 weeks

Biological: Aflunov (No prime, single boost)

Interventions

Aflunov (single prime, single boost) BIOLOGICAL

Priming with single dose 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks

Also known as: Aflunov

Vaccine arm 1

Aflunov (double prime, single boost) BIOLOGICAL

Priming with two doses 7.5microg MF59-adjuvanted A/VN/1194/04 then non-adjuvanted H5N1 vaccine containing 3.75microg at 52 weeks

Also known as: aflunov

Vaccine arm 5

Aflunov (No prime, single boost) BIOLOGICAL

No Priming then MF59-adjuvanted H5N1 vaccine containing 7.5microg at 52 weeks

Also known as: aflunov

Vaccine arm 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
• Are in good health or have one or more stable (See footnote) medical conditions, as determined by:
• Medical history,
• Physical examination,
• Clinical judgment of the medical investigator;
• Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits.
• Subjects who experienced fever (defined as axillary temperature \>38oC) within 3 days prior to Visit 1;
• Subjects who are pregnant or breastfeeding;
• Females of childbearing potential who refuse to use an acceptable method of birth control for a period of 56 days before and after each vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), monogamous relationship with vasectomised partner who has been vasectomised for 6 months or more prior to the subject's study entry, or abstain from heterosexual intercourse (e.g., through sexual orientation or religious or other beliefs about premarital intercourse);
• Subjects with any serious disease, including:
• cancer,
• acute or progressive hepatic disease,
• acute or progressive renal disease,
• chronic pulmonary disease requiring home oxygen therapy,
• active neurological disorder,

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• Medical Research Council: collaborator
• Novartis: collaborator
• Public Health England: collaborator
• National Institute of Biological Standards and Control: collaborator

Study Sites (2)

University Hospitals Leicester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Clincal Trials Unit Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

PRIME protocol

Condition Hierarchy (Ancestors)

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

Study Officials

• Karl G Nicholson, FRCP, MD

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

GB (2)