hoàn thiện quy trình sản xuất và sử dụng vắc xin nhũ dầu tụ huyết trùng trâu bò p52 phòng bệnh tụ huyết trùng cho đàn trâu bò nuôi ở việt nam

neu co So, th&i gian ban hanh van ban Ten van ban Tom tat hoat dong KHCN ciia to chirc dang ky chii tri DA Don dang ky chu tri thirc hien dir an cap nha nuoc Quy6t dinh phe duyet D

8 ^ /r^ r ^

G 6 N G KGHg B() NdNG N G H I S P * PIMfl

£HGN TR.ONO BifeM cAP N H A Ntrd^C KCO4/06-W I

^ ^ ^ ^ ^ ^ i ^ ^ ^ ^ B ^ ^ ^ ^ ^

JO KHOA HOC VA C O N G N G H E BO NONG NGHIEP & PINT

CHirONG TRINH KHCN TRQNG DIEM CAP NBA Nir6'C KC 04/06-10

Dir AN SAN XUAT THU' NGHIEM

BAO CAO TONG HOP

KET QUA KHOA HQC CONG NGHE DlT AN

"HOAN THIEN QUI TRINH SAN XUAT V A SU* DUNG VAC XIN

VIEN THUOC THU Y TW Doc lap - T y do - H a n h p h u c '

S 6 : J J S / D N - C T T Y TP HCM, ngay i^'thang ^Tnam 2010 V/v: De nghi ddnh gia kit qua

de tai/d\e an a cap nha mc&c

Kinh giri: - B a n chu nhi^m Chu-ffng trinh K C 04/06-10

- Van p h o n g cac ChiroTng trinh K H C N t r g n g d i l n c3p Nha nu-d-c

c a n cir vao Thong t u s6:12/2009/TT-BKHCN ngay 08/5 /2009 cua Bp trucmg Bo Khoa hoc va Cong nghe h u a n g dan ve viec danh gia nghiem thu de tai khoa hoc cong nghe va du an san xuat thuc nghiem cap nha nuac, Cong ty TNHH mgl thanh vien thuoc thu y TW de nghi Ban chii nhiem Chuong trinh KC 04/06-10 va Van phong cac Chucrng trinh KHCN trong dien cap Nha nuac xem xet va to chuc danh gia cap nha nuac Icet qua thuc hien doi vai dy an sau day:

Ten du an: Hoan thien quy trlah san xu^t vk su" dung \ic xin nhu dan tu huyet r^'^ng trau b6 chdng P52 ph6ng b^nh tu huyet trung cho dan trSu bd nu6i d Viet Nam

Ma s6 du an: KC 04 DA 07/06-10

Thuoc: - Chuong trinh KHCN trong diim cdp Nha nu&c "Nghien ciJu, phat

trien va rfng dung c6ng ngfad sinh hoc",

M a s6: K C 04/06-10

Hop d6ng KHCN s6: 07/2008/HD - DACT-KC 04 DA 07/06-10

Thai gian thuc hien theo hop dong: tu thang 3 nam 2008 d^n thang 2 nam

2010

Thai gian d u g c dieu chinh, gia han (neu c6) den: Khong

Chu nhiem dir an: TS Tran Xuan Hanh

Du an tren da d u g c hoi dong danh gia c a so hop ngay 13 thang 4 nam 2010, xep loai "Dat"

Kem theo cong van nay la ho so danh gia cap nha n u a c , gom:

1 Bao cao tong hop ket qua, bao cao torn tat va san pham KHCN cua de tai, du

an vcri so luong va yeu cau theo hop dong;

2 Bao cao nhan xet ve to chiic thuc hien cua ca quan chu tri d§ tai, du an;

3 Hop d6ng va thuyet minh de tai, du an kem theo;

4 Thong t u ban hanh danh muc vac xin, ch6 p h i m sinh hoc, vi sinh vat hoa chit dung trong thti y d u g c phep luu hanh tai Viet Nam do Bo NN&PTNT ban hanh

nam 2009; giky chung nhan dang ky san xuit thuoc thii y do Cue thu y cip nam

dung vac xin nhia d4u tu huySt trung trau bo 6k tiem phong tai cac dia phuang;

5 Cac Bien ban kiem tra dinh ky ciia Ban chu nhiem chuong trinh, ca quan chu quan, Bg KH&CN;

6 Bao cao dk nghj quy^t toan tai chinh cua dk tai, dir an;

7 So nhat ky dir an;

8 Quyet dinh va bien ban danh gia cua Hoi dong danh gia cap ca so;

9 Van ban xac nhan ve su thoa thuan cua cac t^c gia ve vice sap xep thu tu ten trong danh sach tac gia thuc hien d6 tai, du ^n;

11 Cac tai lieu khac (n6u c6)

So lugng ho so gom:

- 05 bg (ban sao) diy du tai lieu ke tren;

- 08 bg (ban sao) cac tai lieu tren trir tai lieu so 7 (tai lieu thiet ke, so lieu )

De nghi Ban chu nhiem Chuong trinh KC 04/06-10 va Van phong cac Chuong trinh KHCN trong dien cap Nha nuac xem xet va to chuc danh gia nghiem thu cap nha nuac ket qua d^ tai/du an./i^^:=i-

fioc lap - Ty do - Hanh phuc

TP HCM, ngay ^ thang ^" nam 2010

BAO CAO VE VIEC HOAN THIEN

HO SO DANH GIA CAP CO SO

I Nh&ng thong tin chung

1 Ten du an: Hoan thi$n quy trinh sdn xuat va siJ dung vdc xin nhu dau tu

huyet trung trSu b6 chiing P52 ph6ng benh tu huyet triing cho dan trSu bo nuoi d Viet Nam

Ma s6 dir an: KC 04 DA 07/06-10

Thuoc:

- Chuong trinh KHCN trong dilm cip Nha nuoc "NgMen cilu, phat trien

va ling dung c6ng nghe sinh hoc",

Ma s6: KC 04/06-10

2 Chu nhiem du an: TS Tran Xuan Hanh

3 Co quan chu tri du an: Cong ty thu6c thii y TW - NAVETCO

4 Chii tich hoi d6ng danh gia: PCS TS TrSn Dinh TCr Hoi thu y Viet Nam

5 Thoi gian danh gia: Bat dau: 09gia ngay 13/4/2010

K a thuc: 11 gia, ngay 13 M /2010

II Noi dung da thuc hien theo ket luan cua hoi d6ng c i p ca so:

1 NhiJng noi dung da bo sung hoan thien:

Du an da chinh sila cAc iSi in an, chinh ta, sap xep trat tit cac noi dung

trong bao cao hoan chinh theo gop y cua Hoi dong

- Bo sung nhOng hinh anh va giai thuong du an tham gia hoi chg Techmart Viet Nam Asean + 3 vao thang 9/2009

- Giai thuong TOP TEN NGANH H A N G san phSm thuong hieu Viet hoi nhap WTO cho vac xin tu huyet trung trau bo nhu dau chung P52

3 Nhung vSn de chua hoan thien duac (neu ro ly do):

- IChong

III KiSn nghj ciia chii nhiem de tii/du' an:

Du an da hoan thanh diy dii cac noi dung va vugt dang l<y ve so lugng san phim vac xin nhu d4u tu huyet triing trau bo chung P52 San pham vac xin da dugc sii dung tiem phong de phong benh tu huyet triing cho dan trau bo rat hieu qua tai hau het cac tinh trong nuoc dac biet cac tinh Tay Nguyen va da xuat khau

Be nghi Hoi dong nghiem thu cap nha nuoc cong nhan ket qua du an

CHU NHIEM BE TAX, DU AN

(Ho, ten va chii ky)

TRAN XUAN HANH

XAC NHAN CUA

CHU T I C H H O l D 6 N G

(HQ, ten va chit ky}

XAC NHAN CUA

T 6 cHtrc CHU TRI DE TAI, Dir AN

, chit ky va dong ddu)

'^SooioSr

P G S , T S g i ^ J ) ^ ^

BAO CAO GIAI TRINH MOT SO V A N D E TAI H Q I NGHI NGHIEM THU CAP CO Sd

Du- a n : HOAN THIEN QUI TRINH SAN XUAT VA SU' DUNG VAC XIN NHU DAU

TU HUYET TRUNG TRAU B 6 CHUNG P52 PHONG BENH TV HUYET TRUNG

CHO DAN TRAU BO 6 VIET NAM

1 Noi ro hem ve cai tien moi truong nuoi cay

Cai tien moi trydng nuoi cay de san xuat vac xin nhu dau la van de then chot quyet dinh den thanh cong ciia dir an Qua trinh cai tien dugc thuc hien bang each bo xung mot so cac yeu to dinh duong can thiet nham nang cao sir phat trien ciia vi khuan P.multocida trong dieu kien nuoi cay trong Fermenter voi cac thong so ve pH, toe do khuay dao, do thong Idii (do hoa tan oxy) da dugc chuan hoa

Viec cai tien moi truong thuc hien trong du an nay da dam bao dugc

3 van de:

Tang hieu qua nuoi cay ciia vi khuan P.multocida, chiing P52

Moi trirong de che tao va de kiem soat ve mat chat lugng

Khong CO sir bien dong ve gia thanh san xuat moi tnrong

Thirc te cho thay nong do vi khuan thu hoach dugc tang len khi nuoi cay trong moi truong cai tien khong nhitng dam bao du tieu chuan de san xuat vac xin nhu dau, ma con mang y nghia kinh te rat Ion

Vi day la mot du an san xuat thu nghiem, san pham la vac xin doi hoi ky thuat cao va dieu kien nghiem ngat khi san xuat, hon nira trong dieu kien kinh te thi truong, sir canh tranh giiia cac nha san xuat rat khac nghiet,

do vay viec giii bi mat cong thiic, cac bi quyet la van de can dirge ton trong, vi vay chiing toi xin phep khong neu chi tiet cong thirc, thanh phan moi trucmg cung nhu cong thitc phoi hgp lam nhii dau Tuy nhien chiing toi khang djnh rang chat lugng vac xin san xuat tir moi truong cai tien dat chit lugng tot va dieu nay da dugc chiing minh qua 16 16 vac xin voi hon 7 trieu lieu vac xin da san xuat deu dat tieu chuan chat lugng va khi sir dung trong thuc te cho kit qua an toan va hieu qua bao ho cao

2 Cach che khang nguyen diing trong ky thuat ELISA phat hien Ichang the THT trau bo? Tac gia c6 the dong y chuyen giao ley thuat ELISA?

Ky thuat ELISA dliu tien dugc chung toi phat trien de sir dung phat hien khang the tu huyet triing heo (Septicaemic Pasteurellosis) vgi khang

nguyen diing chua vi khuan Pasteurella multocida serotype B:2 Ky thuat

nay dugc thirc hien tai khoa thu y (Vet School) truong dai hgc Queensland, Australia duoi su huang dan cua giao su Alan Frost Tir ket qua nay, chung toi da chuan hoa de dung kiem tra Idiang the benh tu huyet triing trau bo (Haemorrhagic septicaemia) Khang nguyen diing trong ky thuat nay la khang nguyen chiu nhiet, diing chung VP 816 (hoac) HPKT99 Day la chung dugc phan lap tir mot 6 djch tu huyet triing trau bo va heo tai tinh Kontum vao nam 1999 va bang cac phuong phap khac nhau (huyet thanh hoc, PCR) da xac dinh la vi khuan P multocida serotype B:2 (phuong phap che tao khang nguyen tham khao trong luan an tien sT ciia Tran Xuan Hanh, 2002)

Ve mat chuyen giao ky thuat: Day la mot phuang phap danh gia mien dich trong benh tu huyet trung rat chinh xac va hieu qua ve mat kinh

te, do vay chung toi san sang chuyen giao ky thuat neu dugc yeu cau

3 Loi chinh ta va each trinh bay trong bao cao

Chiing toi da kiem tra lai mot each can than, sira loi chinh ta, cac loi

in an va trinh bay lai mot so bang bieu cho de theo doi hem theo nhu gop y ciia hoi dong

Chu nhiem du an

TS Tran Xuan Hanh

VIEN THUOC THU Y TW Doc lap - T y do - H a n h phiic

TP HCM, ngay Jc thang ,-? nam 2010

D A N H S A C H T A C G I A T H V C H I E N

D E T A I K H C N / D i r A N S X T N C A P N H A N l T d C

(Danh sach nhitng ca nhan da dong gop sang tao chii yeu cho de tai, du an

ditac sap xep theo thit tu do thoa thuan)

1 Ten dir an: H o a n thien quy tiinh s J n xuS't v4 sil dung vdc xin nhu d a u tu huyg't triing trau bo chiing P 5 2 ph6ng bfinh tu huyet triing cho d a n ttau bo nuoi S Vi$t Nam

Ma s6 d u an: K C 04 DA 07/06-10

Thuoc: Chuong trinh KHCN trong diem cdp Nha nuoc "Nghien clJu, ph£t tri^n

v4 iJng dung cong ngh^ sinh hoc"

M a s6: K C 04/06-10

2 Thai gian thirc hien: tir thang 3 nam 2008 dSn thang 2 nam 2010

3 T6 chirc chii tri: Cong ty TNHH mot thanh vien thudc thii y TW-NAVETCO

4 C o quan chu quan: Bo Nong nghiep va PTNT

5 Tac gia thuc hien de tai/dir an tren gom nhimg nguoi c6 ten trong danh sach sau

TS Tran Xuan Hanh

TS Nguyen Thien Thu

TS Pham Quang Thai

BS To Thi Phan

BS VoCongMmh

ThS D6 Vanfiiang

BS Pham Hao Quang

ThS Nguyen Van Dung

KS Nguyen Tang Kien

To chirc cong tac

Cong ty thuoc thu y TW Cong ty thuoc thii y TW C6ng ty thuoc thu y TW - Cong ty thuoc thii y.TW Cong ty thuoc thii y TW Cong ty thuoc thii y TW • Cong ty thuoc thii y TW Cong ty thuoc thii y TW Cong ty thuoc thu y TW

ChCtky

'Wfz^^^'

(Ho, ten vd chu ky)

T h u t r u o n g to chiic chu tri

de tai/du* an

', chir ky vd dong ddu)

^ • s i ^ r r S ^ ^ y n M O GIAM D O C

THUOC THi) Y TW Doc lap - Tir do - Hanh phiic

TP HCM ngay 9 llidng 4 nam 2010

NHAN XET VE TO CHlTC THtfC HIEN

DE TAI KHCN/Dir AN SXTN CAP NHA NlTOfC

1 Thong tin chung:

1 Ten dir an: Ho&n thien quy trinh san xurft va s i dung vac xin nhu diu tu huy^t triing trSu b6 chiing P52 ph6ng bfinh tu huy^t triing cho dJn trau bo nuoi d Vi6t Nam

Ma s8 dif an: KC 04 DA 07/06-10

Thuoc: Chuong trinh KHCN trong diim cap nha nuoc

"Nghi8n ci?u, ph^t trien va itng dung cong nghe sinh hoc",

Ma s6: KC 04/06-10

2 Ten chu nhiem: TS Tran Xuan Hanh

3 Ten to chirc chii tri: Cong ty TNHH mot thanh vien thuoc thu y NAVETCO

TW-4 Tong kinh phi thuc hien: 6.695,876 trieu d6ng

- Trong do, Kinh phi tir ngan sach SNKH: 2.000 tr.d

- Ty le va kinh phi thu h6i (ddi v&i Die an SXTN): 60% bSng 1.200 Tr d

5 Thoi gian thirc hien: 24 thang

- Bat dau (theo hgp dong): thang 3 nam 2008

- KSt thuc (theo hgp d6ng): thang 2 nam 2010

- Dirge dieu chinh, gia han (niu c6) den: Khong

6 Tai lieu kem theo (neu c6): (van ban gia han, ket luan cua thanh tra, kiem tra )

Dir an khong phai gia han

II Nhan xet v l t6 chirc thirc hien:

1 Nhan xet vk Ti6n do thirc hien:

Thuc hien dung han: Dir an trien khai thuc hien dung han

BChSng thuc hien diing han (neu ro ly do ): Khong

chinh

Nhan xet ve tinh hinh huy dong kinh phi theo cam ket

Co quan chu tri da cap dii von tu c6 de trien khai du an nhu da cam ket

3 Nhan xet, ket luan chung:

- Du an dugc t6 chuc thuc hien dat yeu cau ve so lugng, chat lugng cac san pham da dang Ic^ d dang ket qua I, II, III, IV

- Ve tien do thai gian: Dat yeu cau

ThO tru'ong to chirc chu tri

, chu Icy va dong ddu)

D9C lap - Ty do - Hanh phuc

TP Ho Chi minh, ngay 17 thang 03 nam 2010

BAO CAO THONG KE KET QUA THlTC HIEN DE TAI/DU AN SXTN

I THONG TIN CHUNG

1 Ten de tai/du an: Hoan thien qui trinh san xua't va su' dung vac xin nhu

diu tu huye't triing trSu bo chiing P52 phong benh tu huyet triing cho dan trSu bo cl Viet Nam

2 Chii nhiem de tai/dir an:

Ho va ten: Tran Xuan Hanh

Ngay, thang, nam sinh: 1957 Nam/NO: Nam

Hoc ham, hgc vi: Tien si

Chiic danh khoa hgc: Chiic vu: Pho tflng giam d6c Dienthoai: T6 chvrc: 8 38225955 Nha rieng: Mobile: 0908356656 Fax: 08 38225060 E-mail: tranxuananh2002@yahoo.com

Ten to chirc dang cong tac: Cong ty TNHH mot thanh vien thu6c thu y

TW -NAVETCO

Dia chi t6 chirc: 29 Nguyin Dinh Chiiu, Ql, TP H6 Chi Minh

Dia chi nha rieng: 29 Nguyin Dinh ChiSu, Ql TP H6 Chi Minh

3 To chirc chii tri de tai/dir an:

Ten to chiic chu tri Ah tai: Cong ty TNHH mot thanh vien thu6c thu y

TW-NAVETCO

Dien thoai: 8 38225955 Fax: 08 38225060

E-mail: Navetco@hcmc.netnam.vn

Dia chi: 29 Ngiiyin Dinh Chiiu, Ql, TP H6 Chi Minh

Hg va ten thii truong tfl chiic: PHAM QUANG THAI

S6 tai khoan: 931.90.01.00030

Kho bac nha nuoc quan 1 - TP Ho Chi Minh

Ten CO quan chu quan 6h tai: Bp Nong nghiep va PTNT

n TiNH HINH THl/C HIEN

1 Thdi gian thirc hien de tai/dy ^n:

- Theo Hgp dSng da ky kSt: tir thang 3 nam 2008 dSn thang 2 nam 2010

- Thirc te thirc hien; tir thang 3/nam 2008 den thang 2 nam 2010

- Dugc gia han (neu c6): khong

2 Kinh phi va sir dung Itinh phi:

a) T6ng s6 kinh phi thuc hien: 6.695,876 tr.d, trong do:

+ Kinh phi he ttg tir SNKH: 2000 tr.d

+ Kinh phi tir cac nguSn khac: 4.695,876 tr.d

+ Ty le va kinh phi thu h6i d6i vdi dir an (nSu c6): 60% Thu hoi 1.200 tr.d

b) Tinh hinh c4p va sit dung kinh phi tit nguon SNKH:

647

153 2.000

Thuc ti a

Thoi gian (Thang, nam) 9/2008 12/2008 3/2009

2010

at tuac

Kinh phi (Tr.d) Cap 840 Cap 360 Cap 453 Cap 347 2.000

Ghi chu (So de nghi quyet toan)

502,440 tr.d 1.449,2 tr.d 48,36 tr.d

Bdi v&i du an: Ban vi tinh: Trieu dong

cac khoan chi

Thiet bi, may moc

mua moi

Nha xirong xay

dung moi, c^i tao

Kinh phi ho trg

cong nghe

Chi phi lao dgng

Nguy6n vat li?u,

0

700

561,6 1.919,026 1.210 605,25 6.695,876

0

0

361,6 1.219,026 1.210 405,25 4.695,876

Thifc te dat dirffc

Tong 1.709,763

0

700

561,6 1.909,263 1.210 605,25 6.695,876

0

0

361,6 1.209,263 1.210 405,25 4.695,876

(*) Chua tinh kinh phi tic von tu co de SXso hegng vac xin vuat du loan 4 trieu lieu

- Ly do t h a y doi (neu c6):

3 C a c v a n ban h a n h chinh trong qua trinh thurc hien de t a i / d y an:

(Liet ke cac quyet dinh, van ban cua ca quan quan ly tir cong dogn xac dinh nhiem vu, xet chon, phi duyet kinh phi, hop dong, dieu chinh (thai gian, noi dung kinh phi thuc hien neu c6); van ban cm to chuc chi tri de tai, du an (dan, kien nghi dieu chinh neu co)

So, th&i gian ban

hanh van ban

Ten van ban

Tom tat hoat dong KHCN ciia to chirc dang

ky chii tri DA Don dang ky chu tri thirc hien dir an cap nha nuoc

Quy6t dinh phe duyet Danh muc dir an SXTN thuoc cac chuong trinh BCH&CN trong diem cap Nha nuac giai doan 2006-

2010 de xet chon giao trirc tiep thirc hien trong kS hoach 2008

Quyet dinh thanh lap Hoi dong khoa hoc va cong nghe cap Nha nu6c tu van xet chon to chijc ca nhan chu tri thuc hien dir an SXTN

d l thirc hien trong ke hoach nam 20O8 thuoc Chuong trinh "Nghien ciiu, phat trien va ling dung cong nghS sinh hpc"

Ghi chu

Bo KHCN ban hanh

Bo KHCN ban hanh

triing tuyen chu tri thirc hien cac de tai, du

an SXTN nam 2008 (dot I) thuoc Chuong trinh "Nghien ciru, phat trien va img dung cong nghe sinh hoc" ma so KC 04/06-10

Quyet dinh thanll lap to tham dinh de tai KH&CN, dir an SXTN cap Nha nuoc nam

2008 thuQc Chuong trinh "Nghien ciru, phat triln va img dung cong nghe sinh hoc" Ma

S 6 K C 04/06-10

Quy^t djnh phe duyet kinh phi 07 de tai, 02 dir an SXTN bit dlu thirc hien nam 2008 thuoc Chuong trinh KH&CN trong diem cap Nha nuoc giai doan 2006-2010 "Nghien cim, phat trien va img dung cong nghe sinh hoc" Ma so KC 04/06-10

Hgp dong nghien cim khoa hoc va phat trien cong nghe

Ban qui che chi tieu kinh phi Du an SXTN

"Hoan thien qui trinh san xuat va sii: dung vac xin nhu dau tu huyet triing trau bo chUng P52 phong benh tu huyet trung cho dan trau bo ct Viet Nam"

Ma s6: KC 04 DA 07/06-10

Quyet dinh thanh lip Hoi dong nghiem thu cap ca so du an SXTN thuoc Chuong trinh trong diem cap Nha nude

Bo KHCN ban hanh

Bg KHCN ban hanh

Bg KHCN

ban haiili

Van phong cac chircmg trinh, Chuong trinh KC04/06-10-BP KHCN

Co quan chu tri Dir an SXTN ban hanh (NAVETCO)

Co quan chii tri diran (NAVETCO)

Sim phSm cha yeu dat duac

Pham Quang

Thai

To Thi Phan

Nguyen Thien Thu

D6 Van Dung

hi6n triin khai dU

^n theo tie'n dp vd qui trinh cong nghe Phu trdchphat trien mang ludi ph3n pho'i va tieu thu san pham

Phu trach ky thuat

d u a n , hodn thien cac qui trinh san xua't qui mo cong nghiep

Thi/ky dUan Phu trach chuan hoa qui trinh bao quan, van chuyen vacxin;

So sanh vacxm nhu dau vdi cac vacxin truyen thong khac

HoEln thien qui ttinh ki^m nghi§m cac chi tieu vacxin bang phUPng phap thay thS' va trong tai

Phu trach tri^n khai san xu3't vac xin qui m6 cong nghiep

San pham chuyiu dat dugc

To chuc thuc hien day du cac noi dung cua du an, dung tien dp

Hoan tat bao cao

To chuc phat trien mang luoi va Tieu thu hon 6 trieu lieu vac xin nhu dau

- Phu trach ky thuat du an

- Hoan thien cac

qui trinh cong doan

SX cong nghiep vac xin nhu dau Chuan hoa qui trinh bao quan

van c h u y e n , sir dung vac xin nhil Danh gia so sanh

VX nhii v6i cac loai vac xin keo phen khac Xay dung qui trinh kiem nghiem vac xin

Xac dinh do dai mien dich cua vac xin

San xuat duac hon 7 trieu lieu vac xin nhu dau

Gin chu*

Xay dtfng phUdng phap kiem tra mien djch bao ho dan gia sue dUdc tiem vacxin bang

ky thuat ELISA,

Thu nghiem thuc dia danh gia an toan va hieu luc vac xin

Phu trach thiet bi

ky thuat ELISA dung phat hien

khang the P multocida Ung

dung xac dinh khang the bao ho tren dan trau bo duoc tiem vac xin

a thuc dia Khang dinh vac xin an toan va hieu lu'c tren thuc

te san xuat Huong dan su dung thiet bi va dam bao boat dong ciia thiet bi trong san xuat

- Ly do thay doi ( neu co):

6, Tinh hinh hop tac quoc te: Khong

- Ly do thay doi (neu co):

7 Tinh hinh to chuc hoi thao, hoi nghi:

Viing Tay Nguyen

Viing mien Trung

Viing Tay Nam bp

Viing Dong Nam bp

Phia Bac

Hoi nghi khoa hoc co so

nghiem thu tien dp

H3i d6ng KHCN danh gia

nghiem thu cap co so

Thuc te dat dieac

(Noi dung, thai gian, kinh phi, dia diem)

Vac xin va van de phan ling sau khi tiem vac xin

va bien phap phong tri

-To chuc tai Da Lat, thang 8/2009

H u e - 3 / 2 0 1 0 Dong Thap

B a R i a

Ha Noi Danh gia ket qua tien dp cua DA, thang 6/2009, tai

C o n g t y Danh gia nghiem thu co

so ket qua du an - ngay 13/4/2010, tai C o n g t y

Ghi chii*

(Neu tai muc 15 cua thuyet minh, khong bao gom • Hoi (hao khoa hoc dien tra khao adi trong nu&c vd nuac ngoai)

(Cac mSc danh gia chit yeu)

Hoan thien qui trinh cong nghe

san xuat vac xin THT trau bo

nhu dau chiing P52 6 qui mo

cong nghiep

Hoan thien qui trinh ki^m

nghiem vac xin THT trau bo

nhu dSu chimg P52

Xay dung phuong phap danh

gia mien dich va bao h6 ciia vac

xin trong di^u ki6n thuc te' bang

ky thuat ELISA

Xay dirng qui trinh bio quan,

van chuyen va sir dung vac xin

Danh gia so sanh hieu qua

phong benh ciia vac xin nhu

P52 vol cac vac xin truyen

thong khac

San xuat 3 trieu lieu vac xin

THT trau bo nhu dau

Dao tao khoa hpc (NCS thac sT,

sinh vien TNDH)

Dao tao lam chii qui trinh san

xuat, su dung thanh thao thiet bi

6-12/2008

-12/2009

6-12/2008

6/2008 12/2009 6/2008 - 12/2009 12/2009 12/2008

-Thuc te dat duac 12/2008

1 thac sT

1 BS da t6t nghiep

l^gircti,

ca quan thuc hien

BS To Thi Phan

ThS Do Van Dung

BS Pham Hao Quang

TS, l^guyen Thien Thu

TS Nguyen Thien Thu

BS Vo Cong Minh TS.Tran Xuan Hanh

BS To Thi Phin

KS Nguyen Tang Kien

- Ly do thay d6i (neu co):

1 San phSm KH&CN da tao ra:

a) San phim Dang I:

Sd

TT

1

Ten san pham vd

chi tieu ch&t

luang chii yiu

Vac xin nhii dau

THT trau bo chung

P52 dat chat luong

xuat xuong ve vat

ly, vo trung, an toan

Ten san pham

Hoan thien qui trinh

cong nghe san xuat

vac xin THT trau bo

nhu dau chung P52

6 qui mo cong

nghiep

Hoan thiSn qui trinh

kiem nghiem vac

xin THT trau bo nhil

d^u chung P52

Xay dung phuang

phap danh gia mien

dich va bao h6 ciaa

vac xin trong dieu

kien thuc te' bang ky

- Danh gia tinh on dinh

ve vat ly, vo trung, an toan va mien dich cua vac xin

- Danh gia dp dai mien dich cua vac xin

- Danh gia tinh nhay cam va dac hieu cua ky thuat ELISA khi dung kiem tra mien dich THT tren trau bo

- Lien he so sanh giua phuong phap ELISA va phuang phap bao ho thu dong tren chupt khi

Thuc te dat duac Qui trinh san xuat vac xin vo boat tu huyet trung trau

bo nhQ dau chung P52 (qui mo cong nghiep)

Qui trinh kiem nghiem vac xin vo hoat tu huyet trung trau bo nhu dau chung P52

Qui trinh ky thuat ELISA dung phat hien khang the

Pasteurella multocida

serotype B:2

Ghi chu

Dat theo dang ky

Dat theo dangky

Dat theo dangky

4

5

6

Xay dung qui trinh

bao quan vac xin

Xay dung qui trinh

van chuyen vac xin

Xay dung qui trinh

sii dung vac xin

tiem vac xin nhu dau chiing P52

- Moi lien he giua phuong phap ELISA va cong cuang doc Xdc dinh duoc thai gian va dieu kien bao quan vac xin nhu dau

- Qui each dong goi, sap xep thich hop tirng loai bao bi trong, bao bi ngoai theo yeu cau van chuyen

- Danh gia theo doi

nhiSt d6 vh dilu ki6n

Qui trinh bao quan vac xin vo hoat tu huyet triing trau bo nhu dau chung P52 Qui trinh van chuyen vac xin vo hoat tu huyet trung trau bo nhQ dau chung P52

Qui trinh su dung vac xin vo hoat tu huyet trung trau

bo nhij dau chung P52

Dat theo dang ky

Dat theo dang ky

Dat theo dang ky

- Ly do thay doi (neu co):

c) San pham Dang IV:

SS

TT

1

Ten san pham

Kiem tra dap ling mien

dich 6 trau bo sau khi

tiem vac xin tu huyet

triing trau bo bang

phuong phap ELISA

Yeu cau khoa hpc can dat

Theo

kl hoach

1

Thuc te dat duoc

1

SS luang, noicdng bo

(Tap chi, nha xuat ban)

Khoa hgc ky thuat thii y Tap XVI S6 5-2009

Sd

TT

1

2

CSp ddo tao, Chuyen

nganh diio tcio

Thac sy

Tien sy

SS luang

Theo ke hoach

0

0

Thirc te dat dugc

• Ly do thay doi (neu c6):

e) Th6ng ke danh muc san pham KHCN da dugc ung dung

Ten kit qua

da dirofc ung dung

Qui trinh san xuat vac

xin vo hoat tu huyet

trung trau bo nhu dau

chiing P52 (qui mo cong

nghiep)

Qui trinh kiem nghiem

vac xin vo boat tu huyet

trimg trau bo nhu dau

chiing P52

Qui trinh ky thuat

ELISA dung phat hien

khang the Pasteurella

multocida serotype B:2

Qui trinh bao quan vac

xin vo hoat tu huyet

trung trau bo nhu dau

chiing P52

Qui trinh van chuyen

vac xin vo hoat tu huyet

trung trau bo nhu dau

chiing P52

Qui trinh sOr dung

Tlt&i gian

Cong ty TNHH mot thanh vien thuoc thu y TW

Cong ty TNHH mot thanh vien thuoc thii y TW Cong ty TNHH mot thanh vien thuoc thii y TW Cong ty TNHH mot thanh vien thuoc thu y TW

Cac chi cue thii

y Cong ty TNHH

Ap dung de kiem nghiem vac xin THT trau bo nhu dau chiing P52 i truac khi xuat xuong Duac ap dung de danh gia mien dich ciia trau bo duac tiem vac xin THT trau bo

Ap dung tai kho vac xin ciia Cong ty va tai cac chi cue thii y

Ap dung tai Cong ty i Ichi van chuyen vac xin tai cac chi cue thii y va tii cac chi cue toi dia diem tiem phong Cac chi ciic thii y va

chung P52 Cac chi cue thii y

2 f)anh gia ve hieu qua do de tai, du' an mang lai:

a) Hieu qua ve khoa hoc va cong nghe:

- Hoan thien qui trinh cong nghe san xua't vac xin THT trau bo nhu dau chiing P52 o qui mo cong nghiep va on dinh qui trinh la tien de cho viec dap ung san pham theo nhu cau thj truong trong nuoc va xuat l<liau cung nhu ap dung de san xuat cac loai vac xin dang nhO dau khac

- Sir dung cong nghe len men vi sinh hien dai khep kin, ciing voi cong thiic nhu, thiet bi tao nhu cong suat Ion lam cho san pham vac xin tao ra co chat

lugng dong deu va 6n dinh vl chat lugng Vac xin co tinh an toan va hieu lire

cao, miln dich keo dai it nhat 1 nam San pham mang tinh canh tranh cao va phuc vu tot cong tac phong benh THT trau bo ca nuoc mot each hieu qua

- VS cong nghe: Vac xin dugc san xuat dat cong nghe tien tien dugc ap dung

o nhieu nuoc tren thi gioi

b) Hieu qua ve kinh te xa hoi:

Do nhijng iru viet ciia vac xin nhQ dau tu huyet tning trau bo chiing P52 da dugc nghien cuu trong du an, loi ich ciia vac xin the hien cii the nhir sau:

+ Giam so Ian tiem phong tit 1 nam 2 Ian xuong 1 nam 1 Ian (hoac

1,5 lin)

+ Giam chi phi to chirc tiem phong cho cac dja phuong

+ Tiet kiem thgi gian va nhan lire

+ Tang ty le tiem phong va ty le bao ho cho dan trau bo

+ Nang cao hieu qua kinh te cho nguoi chan nuoi

Chi phi t6 chirc tiem phong cho 1 dau trau bo/l nam dugc so sanh:

(d6ng)

Lan tiem/nam

Chi phi tiem phong/lan (d6ng)

Chi phi/con/

nam (d6ng) Ghi chii

So lugng trau bo ca nuoc hien co khoang 8 trieu con, nhu vay neu ty le tiem phong uoc tinh dat khoang 50% (4 trieu con) chi phi cho viec tiem phong vac xin cho moi loai vac xin trong 1 nam se la:

-I- Vac xin keo phen: 4 (trieu con) x 6.600 (dong) = 26,4 ty d6ng /nam -I- Vac xin nhii dau (tiem 1 Ian): 4 trieu x 3424 (d) = 13,7 ty dong/nam -I- Vac xin nhii dau (tiem 1,5 lin): 4 trieu x 5136 (d) = 20,5 ty d6ng/nam

3 Tinh hinh thirc hien che do bao cao, kilm tra cua de tai, da an:

11/11/2008

29/5/2009

11/12/2009

Ghi chii (Tom tat ket qua lie! luan chinh, ngicai

ky dung tien do va chat lugng Da san xuat dii 3 trieu lieu vac xin nhQ dau THT trau bo dat tieu chuin xuat xuong

Hoan thanh toan bg cac noi dung

da dang l^y nam 2008

Da hoan thanh tot cac noi dung da^ dang ky Thuc hien vugt tien do ve

so lugng san pham

- De nghi du an tham gia Techmart Viet Nam ASEAN + 3 (9/2009)

- Du an hoan thanh day du cac noi dung theo dung tien do va co chat lugng

- Hoan tilt hho so, to chirc nghiem thu cap CO so va chuan bi cho nghiem thu cap Nha nuoc

Du dieu kien danh gia ket qua

du-an o c8p Nha nude

Chu nhiem de tai

(Ho ten, chu ky)

T h u t r u o n g to chu'c chu t r i

'n, chu: ky va dong ddu)

T O N G GIAM D O C

TOIVI TAT KET QUA Nham han che nhugc diem cua vac xin THT trau bo keo phen, vac xin

hien nay dang dugc sir dung phong benh THT trau bo a nuac ta, trong

chuong trinh cai tien nang cao chat lugng cua vac xin THT, Trung tam nghien cim thii y thuoc Cong ty thuoc thii y TW-NAVETCO, da nghien ciiu cai tien chat bo trg mien dich ciia vac xin THT trau bo keo phen chimg P52 thanh vac xin THT trau bo nhii dau (vac xin THT trau bo keo phen chiing P52 da dugc hoi dong khoa hgc Bg Nong Nghiep & PTNT thong qua va cho phep sir dung) Vac xin THT trau bo nhii dau chung P52, sau khi nghien ciru thanh cong trong phong thi nghiem da dugc kiem nghiem tai Trung tam kiem nghiem thuoc thii y TW 1 va ket qua dat cac chi tieu ve vo triing, an toan va hieu lire Tir nhimg ket qua thu dugc trong phong thi nghiem va ngoai thuc te san xuat, nham hoan thien mot so van de trong san xuat vac xin nhii dau, de

CO the san xuat theo qui mo cong nghiep, chiing toi de xuat thuc hien du an san xuat thir nghiem nay

Du an thuc hien va hoan thanh 6 noi dung, bao gom: i/ Hoan thien qui trinh cong nghe san xuat vac xin THT trau bo nhii dau chimg P52 qui mo cong nghiep; ii/ Hoan thien qui trinh kiem nghiem vac xin THT nhii dau; iii/ Hoan thien qui trinh bao quan, sir dung, van chuyen vac xin THT trau bo nliQ dau; iv/ So sanh hieu qua ciia vac xin THT trau bo nhii dau chiing P52 voi cac vac xin THT khac; v/ Xay dung phuong phap kiem tra mien djch de danh gia miln dich ciia dan gia site dugc tiem phong vac xin THT; vi/ Thu nghiem tiem phong vac xin trong san xuat

Kit qua cua du an chi ra rang vac xin THT trau bo nhu dau chiing P52 da dugc san xuit thanh cong tai Cong ty thuoc thu y TW - NAVETCO, cong

xuat 250.000 lieu/me (500 lit/me) Voi 7 trieu lilu da san xuSt, vac xin dat tieu chuan ve vat ly, vo triing, an toan, hieu lire va thirc te sir dung vac xin nay trong san xuat chiing minh tinh an toan va hieu qua phong benh cho dan trau bo nuoi Vac xin co do dai bao quan 18 thang o 2-8°C va do dai mien dich it nhat 12 thang (gioi han theo doi) Dac biet trong dilu kien de vac xin

a nhiet do phong 5 ngay (gioi han theo doi), hieu luc ciia vac xin van dugc duy tri, day la im diem rat c6 y nghia doi vol cac viing, a do chua co dieu kien bao quan vac xin nhu qui dinh ciia nha san xuiit hoac chua that su hoan chinh

Dir an cung da chirng minh tinh hon han ciia vac xin THT trau bo nhii dau chung P52 so vol cac vac xin THT trau bo keo phen hien dang dugc san xuat

va luu hanh a nuoc ta Tinh uu viet cua vac xin THT nhu dau khong chi the

hien cr kha nang kich thich dap img mien dich, ma con a cho trau bo tiem phong vac xin nhii dau duy tri dugc miic do bao hg trong thoi gian dai hon (it nhat 12 thang) va chinh vi ly do nay viec sii dung vac xin THT trau bo nhii dau chting P52 se mang lai hieu qua kinh te - xa hoi thong qua cac chi so nhu: giam so lan tiem phong, giam chi phi cho cong tac to chirc va thuc hien tiem phong, tang ty le trau bo dugc tiem phong va gop phan nang cao hieu qua phong benh cho dan trau bo nuoi o nuoc ta

Viec danh gia dap img mien dich sau khi tiem phong vac xin, dac biet kiem tra mien dich quan the la mot van de can thiet trong cong tac quan ly dich benh Doi voi benh THT trau bo viec sir dung cac ky thuat IHA hoac PMPT de kiem tra dap ling mien dich dugc xem xet la khong thuc te do han chi ve do chinh xac va rat ton kem thoi gian va chi phi Ket qua cua du an da chiing minh tinh chinh xac, kinh te khi sii dimg ky thuat ELISA de danh gia

tinh trang mien dich sau khi tiem vac xin THT trau bo nhii dau Uu diem cua

phuang nay la cho ket qua nhanh chong, chinh xac va co the thuc hien voi mot so lugng mau Idn trong ciing mot thoi gian va nhu vay rat thich hgp voi viec kiem tra mien dich quan the Tinh nhay cam va tinh dac hieu ciia ky thuat ELISA dimg phat hien khang the khang vi khhuan P.multocida serotype B:2 da dugc xac dinh tuong img la 96,96 % va 100 % Moi lien he giira hai phuang phap ELISA va PMPT ciing da dugc chimg minh vai chi so Kappa = 0,66 va giu:a phuong phap ELISA voi phuong phap cong cuong doc true tiep tren be la 0,82

Tvr cac ket qua thu dugc trong cac nghien ciiu truac day va cac nghien cim trong du an nay, chung toi da xay dung 6 qui trinh, bao gom: 1/ Qui trinh san xuat vac xin THT trau bo nhii dau chiing P52; ii/ Qui trinh kiem nghiem vac xin THT trau bo nhu d4u chiing P52; iii/ Qui trinh phat hien hien khang thi P.multocida serotype B:2 bang ELISA; Iv/ Qui trinh bao quan vac xin; v/ Qui trinh van chuyen vac xin; vi/ Qui trinh sir dung vac xin Cac qui trinh nay da dugc Hoi dong khoa hgc Cong ty thong qua va ap dung co hieu qua trong san xuat

CHUONG III: VAT LIEU VA PHUONG PHAP THI NGHIEM 10

1 Vat lieu thi nghiem 10

2 Phucmg phap thi nghiem 12

2.1 Phuang phap san xuat vac xin 12

2.2 Phucmg phap kiem nghiem vac xin 12

2.2.1 Kiem tra tinh chat vat ly cua vac xin 12

2.2.2 Kiem tra vo triing vac xin 13

2.2.3 Kiem tra an toan vac xin 13

2.2.4 Kiem tra hieu luc vac xin 13

3 Phuang phap xac dinh do dai mien dich va do dai bao quan 14

3.1 Phuong phap xac dinh do dai bao quan 14

3.2 Phuang phap xac dinh do dai mien dich 14

4 Mot so phuang phap huyet thanh hoc 15

4.1 Phuang phap bao hg chugt thu dong (Passive Mouse Protection 15

Test-PMPT)

4.2 Ky thuat ELISA 15

5 Cac phuang phap xac dinh nong do vi khuan 16

6 Phucmg phap liy huyet thanh 17

CHUONG IV: KET QUA VA T H A O LUAN 19

N Q I DUNG 1: "Hoan thien qui trinh cong nghe san xuat vac xin 19

THT trau bo nhii dau chiing P52 qui mo cong nghiep"

N Q I DUNG 2: "Hoan thien qui trinh kiem nghiem vac xin THT 40

nhii dau"

N Q I D U N G 3: "Hoan thien qui trinh bao quan, sir dung, van 46

chuyen vac xin THT trau bo nhii dau"

N Q I D U N G 4: So sanh hieu qua cua vac xin THT trau bo nhii dau 52

chimg P52 vai cac vac xin THT khac

N Q I D U N G 5: Xay dung phuong phap kiem tra mien djch de 58

danh gia mien dich cua dan gia sue dugc tiem phong vac xin

THT

N Q I D U N G 6: Thir nghiem tiem phong vac xin trong san xuat 64

CHUONG V: M Q T SO D A N H GIA TONG Q U A T VE KET QUA

CilA DU" A N 67 CHLTONG VI: KET LUAN vA DE NGHI 70

KET LUAN

DENGHI

T A I LIEU THAM K H A O 72

CHLTONG VII: NHUT^IG SAN P H A M CUA DU A N 77

1 So lugng vac xin san xuat

2 Qui trinh san xuit vac xin THT trau bo nhQ dau chiing P52

3 Qui trinh kilm nghiem vac xin THT trau bo nhii dau chimg

6 Qui trinh van chuyen vac xin

7 Qui trinh sii dung vac xin

CHUONG Vni: P H A N PHU LUC

DANH IVIUC BANG VA BIEU DO

Bang 1.1: Chi so thanh phan dinh duong ciia moi truong Hottinger 20 cai tien so sanh vai moi truong Hottinger thong thuang

Bang 1.2: So lugng vi khuan nuoi cay trong moi truong Hottinger 21 cai tien

Bang 1.3: Chi so ky thuat thich hgp va ket qua nuoi cay vi Ichuan 24 Bang 1.4 Ket qua kiem tra tinh on djnh ciia vac xin nhii dau 30 Bang 1.5: Hieu luc ciia vac xin voi nong do canh khuan khac nhau 34 khi dimg lam nhu dau

Bang 1.6 : Ket qua kiem tra tinh chat ciia nhu dau sau 3 thang bao 35 quan a 2-8°C

Bang 2.1; Ket qua kiem tra vat ly vac xin THT trau bo nhu dau 41

1 Bang 2.2: Hieu luc cua vac xin Tu huyet triing trau bo nhu dau 42 chimg P52

) Bang 2.3: Dp dai mien djch cua vac xin THT trau bo nhii dau chiing 44 P52

10.Bang 3.1: Do dai bao quan cua vac xin THT trau bo nhii dau, 47 chiing P52

11 Bang 3.2: Hieu luc ciia vac xin THT trau bo nhu dau chiing P52 a 50

cac thai gian khac nhau khi bao quan o nhiet do phong

12.Bang 4.1: Kit qua xac dinh mien dich a bo bjng ky thuat ELISA 53 sau khi tiem vac xin THT trau bo a cac thoi gian khac nhau

IS.Bang 4.2: Lien he giiia hai phuong phap ELISA va PMPM dimg 55 danh gia miln djch chdng benh THT trau bo

14.Bang 5.1: Danh gia tinh nhay cam va dac hieu cua ky thuat ELISA 60

khi diing kiem tra mien djch benh THT tren trau bo

IS.Bang 5.2: Moi hen he giua hai phuong phap ELISA va PMPT 61 16.Bang 5.3: Moi lien he giiia ELISA va ket qua cong cuong doc 62 17.Bang 6.1: Dap img mien djch 6 trau bo sau khi tiem vac xin THT 65 trau bo nhii dau chiing P52, xac djnh bjng ky thuat ELISA

18.So do tong quat qua trinh san xuat vac xin THT trau bo nhu dau 39 19.Bleu do 4.1: Ty le mau huyet thanh duong tinh ciia cac 16 thi 54 nghiem xac dinh bang ELISA o cac thai diem khac nhau sau khi

tiem vac xin

20.Bieu do 4.2: Bien dong hieu gia khang the cua cac 16 thi nghiem 56 xac djnh a cac thai diem khac nhau sau khi tiem vac xin

Tir VIET TAT

TSB : Tryptone Soya Broth

TSA : Tryptone Soya Agar

CPU : Colony Forming Unit (Don vj tao khuan lac)

ELISA: Enzyme Linked Immunosorbent Assay

FAQ : Food Agricultural Organization (To chirc N6ng luong the giai) THT : Tu Huyet Trung

IHA : Indirect Haemagglutination (Ngung ket hong cau gian tiep)

LD : Lethal Dose (Lieu gay chet)

MLD : Minimum Lethal Dose (Lieu gay chet toi thieu)

OD : Optical Density (Mat do quang hoc)

OIE : Office international des epizooties (To chirc djch te the giai) PMPT: Passive Mouse Protection Test

ET : ELISA titration

.-8 .3