# Presentation: 667089

## Influenza Vaccine Responses 

**Zhiping Ye, M.D., Ph.D.**
**Division of Viral Products**

**Prepared for **
**Vaccines and Related Biological **
**Products Advisory Committee**
**28 February 2007**

## Serum panels used for serology 

**AUSTRALIA    IAN BARR, PH.D.****	****  ****	****ADULTS ****	****	****A/NEW CALEDONIA/20/99 (H1N1) **
**	****     ****WHO, AUSTRALIA****	****    ****	****ELDERLY ****	****	****A/NEW YORK/55/04 (H3N2)****	**
**	****	****	****	****	****	****B/MALAYSIA/2506/05 **
**EUROPE****	****    JOHN WOOD, PH.D. ****	****    ****	****ADULTS ****	****	****A/NEW CALEDONIA/20/99 (H1N1) **
**	****    ****NIBSC, ENGLAND ****	****    ****	****ELDERLY ****	****	****A/WISCONSIN/67/05 (H3N2) **
**	****	****	****	****	****	****or A/HIROSHIMA/52/2006 (H3N2) **
**	****	****	****	****	****	****B/MALAYSIA/2506/05 **
**JAPAN ****	****    TAKATO ODIGARI, PH.D.    ****	****ADULTS ****	****	****A/NEW CALEDONIA/20/99 (H1N1)**
** ****	****    ****NIID, JAPAN ****	****    ****	****ELDERLY ****	****	****A/HIROSHIMA/52/2006 (H3N2) ****	**
**	****	****	****	****	****	****B/MALAYSIA/2506/05 **
**USA ****	****    STEFAN GRAVENSTEIN, M.D.  ****	****ADULTS ****	****	****A/NEW CALEDONIA/20/99 (H1N1) **
**	****    ****EASTERN VIRGINIA   ****	****ELDERLY ****	****	****A/WISCONSIN/67/05 (H3N2) **
**	****    ****MEDICAL SCHOOL, ****	****    ****	****PEDIATRIC ****	****B/MALAYSIA/2506/05 ****	****	****	****	****	****	****	**

**1**

## Antigens for serology (H1N1)

_**VACCINE STRAIN**_
**A/New Caledonia/20/99 IVR116**
_**REPRESENTATIVE CURRENT STRAINS**_
**A/England/555/2006**
**A/Fukushima/141/2006**
**A/Guangxigangbei/322/2006**
**A/St. Petersburg/8/2006 **
**A/Hong Kong/2652/2006*******
**A/Norway/2289/2006*******
**A/Solomon Islands/3/2006********* **
**	****	****	****	****	***** K144E Change Present**

**2**

## HI ANTIBODY RESPONSES TO THE H1N1  ADULT POPULATION (UK)

| Trial |  | Virus strain | Pre-vacc %
HI>40 | Post-vacc %
HI>40 | %
rise | pre-vacc
GMT | Post-vacc GMT |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Adult
EU –W | 24 | A/New Caledonia/20/99 | 21 | 88 | 75 | 10 | 190 |
|  |  | A/England/555/2006 | 0 | 46 | 46 | 6 | 36 |
|  |  | A/Fukushima/141/06 | 0 | 63 | 63 | 5 | 63 |
|  |  | A/Norway/2289/2006*(K114E) | 0 | 63 | 58 | 6 | 61 |
|  |  | A/Solomon Islands/3/06*(K114E) | 13 | 67 | 63 | 9 | 133 |
|  |  | A/St. Petersburg/8/06 | 4 | 75 | 71 | 6 | 90 |
|  |  | A/Virginia/1/2006 | 13 | 75 | 67 | 8 | 122 |
| Adult
Australia | 24 | A/New Caledonia/20/99 | 71 | 96 | 21 | 88 | 192 |
|  |  | A/England/555/2006 | 46 | 71 | 17 | 23 | 42 |
|  |  | A/Fukushima/141/06 | 63 | 79 | 17 | 39 | 91 |
|  |  | A/Norway/2289/2006 *(K114E) | 33 | 58 | 17 | 18 | 38 |
|  |  | A/Solomon Islands/3/06 *(K114E) | 71 | 83 | 8 | 52 | 91 |
|  |  | A/St. Petersburg/8/06 | 42 | 71 | 17 | 24 | 48 |
|  |  | A/Virginia/1/2006 | 54 | 88 | 17 | 41 | 77 |

**3**

## HI ANTIBODY RESPONSES TO THE H1N1  ADULT POPULATION (UK)

| Trial | No. of
Sera | Virus strain | Pre-vacc %
HI>40 | Post-vacc %
HI>40 | %
rise | pre-vacc
GMT | Post-vacc GMT |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Adult
USA | 24 | A/New Caledonia/20/99 | 71 | 100 | 38 | 89 | 273 |
|  |  | A/England/555/2006 | 33 | 63 | 25 | 13 | 40 |
|  |  | A/Fukushima/141/06 | 54 | 71 | 21 | 24 | 58 |
|  |  | A/Norway/2289/2006 *(K114E) | 29 | 63 | 25 | 14 | 32 |
|  |  | A/Solomon Islands/3/06 *(K114E) | 50 | 83 | 25 | 38 | 105 |
|  |  | A/St. Petersburg/8/06 | 33 | 71 | 38 | 21 | 61 |
|  |  | A/Virginia/1/2006 | 50 | 92 | 50 | 35 | 130 |
| Adult
Japan | 30 | A/New Caledonia/20/99 | 33 | 80 | 27 | 19 | 59 |
|  |  | A/England/555/2006 | 13 | 27 | 17 | 9 | 22 |
|  |  | A/Fukushima/141/06 | 13 | 37 | 17 | 10 | 26 |
|  |  | A/Norway/2289/2006 *(K114E) | 3 | 23 | 17 | 7 | 16 |
|  |  | A/Solomon Islands/3/06 *(K114E) | 10 | 53 | 33 | 10 | 30 |
|  |  | A/St. Petersburg/8/06 | 10 | 37 | 20 | 9 | 20 |
|  |  | A/Virginia/1/2006 | 50 | 87 | 27 | 27 | 74 |

**4**

## A/New Caledonia/20/99 VACCINESSUMMARY TABLEVIRUSES WITH > 50% GMT REDUCTION (ADULT)

**5**

## Antigens for serology (H3N2)

_**VACCINE STRAIN**_
**A/Wisconsin/67/2005 X161B **
**A/Hiroshima/52/2006 IVR-142**
_**REPRESENTATIVE CURRENT STRAINS**_
**A/Brisbane/9/2006 **
**A/Hiroshima/33/2005**
**A/Norway/2250/2006**
**A/Sendai-H/F131/2006 **
**A/Santiago/7981/2006 **
**A/Canada/1212/2006********* **
**A/Lyon/1292/2006*******
**	****	****	****	*****Canada/Nepal Genetic Group **

**6**

## HI ANTIBODY RESPONSES TO THE H3N2 ADULT POPULATION (CDC)

| Trial | N | Antigen | % Rise | Pre-
vacc
GMT | Post-
vacc
GMT | Pre-
vacc %  
HI>40 | Post- vacc %  
HI>40 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Australia | 24 | A/Wisconsin/67/2005  | 71 | 15 | 101 | 25 | 96 |
|  | 24 | A/Brisbane/9/2006 | 67 | 15 | 65 | 21 | 79 |
|  | 24 | A/Santiago/7981/2006 | 46 | 8 | 22 | 8 | 38 |
|  | 23 | A/Canada/1212/2006* | 4 | 8 | 14 | 4 | 9 |
|  | 23 | A/Hiroshima/33/2006 | 42 | 7 | 14 | 8 | 22 |
| UK | 24 | A/Wisconsin/67/2005  | 79 | 9 | 151 | 13 | 88 |
|  | 24 | A/Brisbane/9/2006 | 75 | 7 | 92 | 4 | 83 |
|  | 24 | A/Santiago/7981/2006 | 50 | 6 | 18 | 4 | 42 |
|  | 24 | A/Canada/1212/2006 * | 38 | 6 | 14 | 4 | 25 |
|  | 24 | A/Hiroshima/33/2006 | 42 | 5 | 15 | 4 | 33 |

**7**

## HI ANTIBODY RESPONSES TO THE H3N2 ADULT POPULATION (CDC)

| Population | N | Antigen | % Rise | Pre-
vacc
GMT | Post-
vacc
GMT | Pre-
vacc %  
HI>40 | Post- vacc %  
HI>40 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Japan | 30 | A/Wisconsin/67/2005  | 40 | 22 | 67 | 40 | 70 |
|  | 30 | A/Brisbane/9/2006 | 33 | 16 | 39 | 30 | 53 |
|  | 30 | A/Santiago/7981/2006 | 13 | 6 | 10 | 3 | 20 |
|  | 30 | A/Canada/1212/2006 * | 23 | 9 | 17 | 7 | 27 |
|  | 28 | A/Hiroshima/33/2006 | 21 | 6 | 10 | 0 | 21 |
| USA | 24 | A/Wisconsin/67/2005  | 83 | 14 | 120 | 33 | 100 |
|  | 24 | A/Brisbane/9/2006 | 79 | 13 | 78 | 21 | 88 |
|  | 24 | A/Santiago/7981/2006 | 50 | 7 | 23 | 4 | 38 |
|  | 24 | A/Canada/1212/2006 * | 67 | 5 | 19 | 0 | 25 |
|  | 24 | A/Hiroshima/33/2006 | 46 | 9 | 23 | 4 | 33 |

**8**

## A/Wisconsin/67/2005-like VACCINESSUMMARY TABLEVIRUSES WITH > 50% GMT REDUCTION (ADULT)

**9**

## Antigens for serology (B)

_**VACCINE STRAIN**_
**B/Malaysia/2506/2004 (****B/Victora/2/87-HA lineage)**
_**REPRESENTATIVE CURRENT STRAINS**_
**B/Bangladesh/5278/2006 **
**B/Texas/39/2006 **
**B/Chongqing-Y/131/2006  **
**B/Madagascar/2866/2006**
**B/Michigan/2/2006*******
**B/Taiwan/79/2006*******
**B/Florida/4/2006*******
**B/Egypt/144/2005*******
**	****	****	****	***** ****B/Yamagata/16/88-HA lineage**

**10**

## HI ANTIBODY RESPONSES TO B ADULT POPULATION (CDC)

|  | N | Antigen | % Rise | Pre-
vacc
GMT | Post-
vacc
GMT | Pre-
vacc %  
HI>40 | Post- vacc %  
HI>40 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| UK | 24 | B/Malaysia/2506/2004 | 83 | 8 | 69 | 8 | 79 |
|  | 24 | B/Ohio/1/2005  | 89 | 11 | 126 | 21 | 91 |
|  | 24 | B/Chongqing/Yz131/2006  | 83 | 8 | 64 | 13 | 71 |
|  | 19 | B/Texas/39/2006  | 83 | 7 | 60 | 9 | 67 |
|  | 23 | B/Florida/4/2006* | 58 | 12 | 44 | 17 | 71 |
|  | 23 | B/Michigan/2/2006* | 63 | 10 | 42 | 17 | 67 |
| Japan | 30 | B/Malaysia/2506/2004 | 23 | 20 | 52 | 40 | 77 |
|  | 30 | B/Ohio/1/2005  | 20 | 32 | 78 | 57 | 80 |
|  | 30 | B/Chongqing/Yz131/2006  | 27 | 17 | 44 | 33 | 67 |
|  | 30 | B/Texas/39/2006  | 23 | 19 | 44 | 37 | 70 |
|  | 30 | B/Florida/4/2006* | 7 | 12 | 19 | 17 | 33 |
|  | 30 | B/Michigan/2/2006* | 7 | 11 | 14 | 13 | 27 |
| USA | 24 | B/Malaysia/2506/2004  | 71 | 21 | 147 | 38 | 96 |
|  | 23 | B/Ohio/1/2005  | 65 | 22 | 151 | 46 | 91 |
|  | 24 | B/Chongqing/Yz131/2006  | 67 | 19 | 127 | 33 | 92 |
|  | 22 | B/Texas/39/2006  | 59 | 23 | 113 | 41 | 88 |
|  | 24 | B/Florida/4/2006* | 38 | 36 | 116 | 63 | 88 |
|  | 24 | B/Michigan/2/2006* | 46 | 48 | 160 | 67 | 92 |

**11**

## B/Malaysia/2560/2004 VACCINESSUMMARY TABLEVIRUSES WITH > 50% GMT REDUCTION (ADULT)

**12**

## Serologic conclusions

**Studies with sera collected after immunization with current vaccines show that:**
**H1**
**Recent viruses ****not**** well inhibited ****compared to the current vaccine strain**
**H3**
**Recent viruses ****not**** ****well inhibited compared to the current vaccine strain**
**B**
**Recent B/Vic lineage viruses ****generally ****well**** inhibited compared to the current vaccine strain**

**13**