National Vaccine Advisory CommitteeJune 7, 2005

Pandemic Influenza Vaccine Research and Development

Linda C. Lambert

Chief, Respiratory Diseases BranchDivision of Microbiology and Infectious Diseases

NIAID/NIH/DHHS

Sanofi Pasteur H5 Vaccine

• Vaccine candidate manufactured using reverse genetics under NIH contract

• Inactivated vaccine received in March• Adult trial began April at 3 VTEUs

– 7.5, 15, 45, 90 mcg vs. placebo; 2 doses

• Enrollment completed mid May• Final results expected in late summer• Separate trials planned in elderly and

children, 2 dose regimen, dosage based on adult data

Chiron H5 Vaccine

• Vaccine candidate manufactured using reverse genetics under NIH contract

• 10,000 doses

• Vaccine anticipated late Fall 2005

• Clinical trial plan: adults, elderly and children

• 2 dose regimen, ~ 1 month apart

H5 Vaccine Dose Optimization StrategiesRoute• Intramuscular (IM) versus Intradermal (ID)

administration of inactivated H5 vaccine. • Phase I protocol filed to FDA• Trial start date July (planned)• Data expected Q3 2005

Adjuvants• Subcontract to Baxter to produce whole virus

inactivated H5 vaccine (Vero) +/- alum• Discussions with Chiron and Sanofi Pasteur

ongoing

GSK TIV Clinical Trial

NIAID rapidly initiated a Phase III trial to evaluate safety and immunogenicity of GSK’s inter-pandemic Fluarix® vaccine in healthy adults:

-- Trial began in Dec. 2004

-- 952 subjects enrolled in 5 days

-- Trial conducted through VTEUs

-- BLA submitted May 25th

Non-egg based technologies

NIAID supports projects aimed at developing alternatives to production of influenza vaccine in eggs:

- Recombinant protein

- Virus-like particles

- Cell culture-based technology

- Alphavirus vector

- DNA based vaccines