national vaccine advisory committee june 7, 2005 pandemic influenza vaccine research and development...

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