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Testing the H1N1 Pandemic Flu Vaccines
Mexico City, Time Magazine, April 2009
Mini-Med School
Karen Kotloff, MD
University of Maryland School of Medicine
Center for Vaccine Development
September 8, 2010
CVD
Unfolding of the H1N1
flu pandemic
Feb 2009: First cases in Mexico
April 15: First cases detected in U.S.
April 26: DHHS declares Public Health Emergency
May 29: Cases in 49 U.S. states and 53 countries
June 11: WHO declares a Global Pandemic
Aug 4:
 Global: 162,380 confirmed cases and 1,154 deaths
 U.S.: 6,506 hospitalizations and 436 deaths
CVD
What is Influenza?
Viral infection of respiratory tract
Spreads person-to-person by coughing
and sneezing
Usually wintertime
Symptoms: Fever, runny nose, cough,
sore throat, body aches
20,000-40,000 deaths each year
CVD
 Triple reasssortant swine flu
viruses (genes from human,
swine, and birds) have been
identified in swine in the US
since 1998
 12 cases in humans were
identified in 2005-9
 On April 15 and 17, two
cases were identified in US
with a new combination of
gene segments
CVD
How does H1N1 flu behave
differently from standard,
“seasonal” flu?
CVD
Ventured into warmer months
Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S.
Outpatient ILI Surveillance Network (ILINet), National Summary 20082009 and Previous Two Seasons, until Week Ending August 1, 2009)
May 1, 2009
Affected people are younger than with
seasonal flu
From EU July 2009
CVD
Distribution of deaths from H1N1 flu in U.S. by
age group
65+ years
9%
0 to 4 years
2%
5 to 24 years
21%
50 to 64 years
26%
25 to 49 years
42%
CVD
H1N1 is more contagious than season flu
2009
H1N1
CVD
The result is..
CVD
Risk groups for H1N1 pandemic 2009 flu
People with chronic conditions in the
particularly those that compromise their
immunity or respiratory function,
including severe or morbid obesity
Pregnant women
Young children (particularly those less
than 2 years of age)
CVD
Vaccines are highly effective in preventing flu
Inactivated flu
shot
Live, nasal
spray vaccine
Weakened
Flu strains expected
to circulate in
community
• Killed
• Split
• Purified
H1N1 vaccine is made the same way
CVD
Studies are needed to inform policy
People with some immunity respond better to flu vaccines –
we need to know the best way to vaccinate a population
that has little pre-existing immunity
How many doses are needed in different age groups
Can the standard strength be used or is a higher strength
vaccine needed?
Can H1N1 vaccine be given at the same time as the
seasonal flu vaccine?
Is it safe and effective in persons at increased risk?
Are there ways to make the vaccine work at lower doses
so there’s more to go around?
Studies at the Vaccine Testing and Evaluation Units will
attempt to answer these questions
CVD
NIAID Vaccine Testing and Evaluation
Units
CVD
Study Overview
200 subjects age 18-64 years old
200 subjects age ≥ 65 years old
If safe,
200 subjects 6-35 months
200 subjects 3-9 years
200 subjects 10-17 years
Multiple Sites
CVD
Rationale for This Study
1) Explore two dose levels:
15 mcg “standard”
30 mcg “high-dose”
2) Explore 1 dose or 2 doses:
Dose 1
Dose 2
21 days
21 days
3) Explore how quickly immune responses likely
to be protective are elicited
CVD
Methods
1. Safety and Reactogenicity
7-day Diary after each dose
Adverse Effects at each of 5 visits plus phone calls for 7 months
Changes in Medical History and Medications
2. Immunogenicity
Serum Antibody
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
CVD
Impact
Cases
Vaccine
available
Study results
available
Summer
School
starts
Winter
CVD
How to avoid contracting swine H1N1
flu
CVD
How to avoid contracting swine H1N1
flu
CVD