KR100805991B1 - 백신 - Google Patents
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- KR100805991B1 KR100805991B1 KR1020037003731A KR20037003731A KR100805991B1 KR 100805991 B1 KR100805991 B1 KR 100805991B1 KR 1020037003731 A KR1020037003731 A KR 1020037003731A KR 20037003731 A KR20037003731 A KR 20037003731A KR 100805991 B1 KR100805991 B1 KR 100805991B1
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- Prior art keywords
- protein
- polysaccharide
- pneumococcal
- vaccine
- antigen
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Abstract
Description
PS 에스. 뉴모니애-단백질 D 컨쥬게이트의 특이적 활성화/커플링/정지 조건 | ||||||
혈청형 | 1 | 3 | 4 | 5 | 6B | 7F |
PS 농도 (mg/ml) | 2.0 | 3.0 | 2.0 | 7.5 | 5.4 | 3.0 |
PS 용해 | NaCl 2M | NaCl 2M | H2O | H2O | NaCl 2M | NaCl 2M |
PD 농도 (mg/ml) | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 |
초기 PS/PD 비율(w/w) | 1/1 | 1/1 | 1/1 | 1/1 | 1/1 | 1/1 |
CDAP 농도 (mg/mg PS) | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 |
pHa=pHc=pHq | 9.0/9.0/9.0 | 9.0/9.0/9.0 | 9.0/9.0/9.0 | 9.0/9.0/9.0 | 9.5/9.5/9.0 | 9.0/9.0/9.0 |
혈청형 | 9V | 14 | 18C | 19F | 23F |
PS 농도 (mg/ml) | 2.5 | 2.5 | 2.0 | 4.0 | 3.3 |
PS 용해 | NaCl 2M | NaCl 2M | H2O | NaCl 2M | NaCl 2M |
PD 농도 (mg/ml) | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 |
초기 PS/PD 비율(w/w) | 1/0.75 | 1/0.75 | 1/1 | 1/0.5 | 1/1 |
CDAP 농도 (mg/mg PS) | 0.75 | 0.75 | 0.75 | 0.75 | 0.75 |
pHa=pHc=pHq | 8.5/8.5/9.0 | 9.0/9.0/9.0 | 9.0/9.0/9.0 | 10/9.5/9.0 | 9.0/9.0/9.0 |
11가 폐렴구균 PS-PD 백신의 특성 (배치 코드의 첫번째 숫자는 혈청형을 나타냄) | |||||
기준 | D01PDJ227 | D03PDJ236 | D4PDJ228 | D5PDJ235 | D6PDJ209 |
PS/Prot 비율 (w/w) | 1/0.66 | 1/1.09 | 1/0.86 | 1/0.86 | 1/0.69 |
유리 폴리사카라이드 함량(%) <10% | 1 | 1 | 7 | 9 | 10 |
유리 단백질 함량(%) <15% | 8 | <1 | 19 | 21 | 9 |
DMAP 함량 (ng/㎍ PS) <0.5 ng/㎍ PS | 0.2 | 0.6 | 0.4 | 1.2 | 0.3 |
분자 크기 (Kav) | 0.18 | 0.13 | 0.12 | 0.11 | 0.13 |
안정성 | 변화 없음 | 변화 없음 | 변화 없음 | 약간의 변화 | 변화 없음 |
기준 | D07PDJ225 | D09PDJ222 | D14PDJ202 | D18PDJ221 | D19PDJ206 | D23PDJ212 |
PS/Prot (w/w) | 1/0.58 | 1/0.80 | 1/0.68 | 1/0.62 | 1/0.45 | 1/0.74 |
유리 폴리사카라이드 함량(%) <10% | 1 | <1 | <1 | 4 | 4 | 0 |
유리 단백질 함량(%) <15% | 8 | 0.3 | 3 | 21 | 10 | 12 |
DMAP 함량 (ng/㎍ PS) <0.5 ng/㎍ PS | 0.1 | 0.6 | 0.3 | 0.2 | 0.1 | 0.9 |
분자 크기 (Kav) | 0.14 | 0.14 | 0.17 | 0.10 | 0.12 | 0.12 |
안정성 | 변화 없음 | 변화 없음 | 변화 없음 | 변화 없음 | 변화 발생 | 변화 없음 |
그룹 | 성분 | 항혈청내 IgG 농도 |
G1 | α-PS-6B | 5 ㎍/ml |
G2 | α-PS-6B | 2 ㎍/ml |
G3 | α-PS-6B | 0.75 ㎍/ml |
G4 | 대조군 | 0 ㎍/ml |
래트 혈청 내 IgG 농도(㎍/ml) | 감염 후 세균 숫자 (log 10 cfu/폐) | |
감염 3일후 | 감염 8일후 | |
5 | 6.7 ±0.7 (1/7) | 7.2 ±0.7 (5/8) |
2 | 6.5 ±0.7 (1/7) | 6.9 ±1.8 (4/7) |
0.75 | 7.7 ±0.5 (5/8) | 4.8 ±1.4 (2/8) |
0 | 6.7 ±1.5 (3/6) | 6.3 ±1.5 (3/9) |
괄호 내의 숫자는 시료 채취 전에 죽은 동물의 숫자임 |
그룹 | 주사 부피 (능동) | 백신 제공일 -22일, -14일 (투여량 ㎍) | 주사 부피 (수동) | 수동 IgG (-1일) |
1-1 | 100 ㎕ s.c. | 단백질/AlPO4 (10/50) | 없음 | |
1-2 | 100 ㎕ s.c. | 단백질/MPL/AlPO4 (10/5/50) | 없음 | |
1-3 | 100 ㎕ s.c. | 단백질/AlPO4 (10/50) | 100 ㎕ i.p. | α-PS |
1-4 | 100 ㎕ s.c. | 단백질/MPL/AlPO4 (10/5/50) | 100 ㎕ i.p. | α-PS |
1-5 | 100 ㎕ s.c. | MPL/AlPO4 (5/50) | 100 ㎕ i.p. | α-PS |
1-6 | 100 ㎕ s.c. | MPL/AlPO4 (5/50) | 없음 |
Claims (16)
- 4가지 이상의 스트렙토코커스 뉴모니애 폴리사카라이드 항원 및 PhtA, PhtD, PhtB, PhtE, SpsA, LytB, LytC, LytA, Sp42, Sp125, Sp101, Sp128, Sp13O 및 Sp133으로 이루어지는 군 중에서 선택되는 하나 이상의 스트렙토코커스 뉴모니애 단백질 항원을 포함하는 면역원 조성물.
- 제1항에 있어서, 폴리사카라이드 항원이 폴리사카라이드-단백질 캐리어 컨쥬게이트의 형태로 존재하고, 캐리어 단백질이 디프테리아 톡소이드 및 파상풍 톡소이드, 교차반응물질 (Cross Reactive Material (CRM)) 197, 키홀 림펫 헤모시아닌 (Keyhole Limpet Haemocyanin (KLH)), 튜베르큘린 (Tuberculin)의 단백질 유도체 (PPD) 및 에이치. 인플루엔자의 단백질 D로 이루어지는 군 중에서 선택되는 것인 면역원 조성물.
- 삭제
- 삭제
- 제1항에 있어서, 어쥬번트를 추가로 포함하는 면역원 조성물.
- 제5항에 있어서, 어쥬번트가 알루미늄염을 포함하는 것인 면역원 조성물.
- 제5항에 있어서, 어쥬번트가 TH1 반응의 우선적 인듀서인 면역원 조성물.
- 제7항에 있어서, 어쥬번트가 3D-MPL, 사포닌 면역자극제 또는 면역자극성 CpG 올리고뉴클레오티드 중의 하나 이상을 포함하는 것인 면역원 조성물.
- 제8항에 있어서, 어쥬번트가 수중유 에멀젼, 리포좀 및 알루미늄염으로 이루어지는 군 중에서 선택되는 캐리어를 포함하는 것인 면역원 조성물.
- 삭제
- 제1항, 제2항 및 제5항 내지 제9항 중 어느 한 항 기재의 면역원 조성물을 포함하는 백신.
- 삭제
- 삭제
- 삭제
- 4가지 이상의 폐렴구균 폴리사카라이드 항원들을 선택하는 단계,PhtA, PhtD, PhtB, PhtE, SpsA, LytB, LytC, LytA, Sp125, Sp1O1, Sp128, Sp130 및 Sp133으로 이루어지는 군 중에서 선택되는 하나 이상의 폐렴구균 단백질 항원(들)을 선택하는 단계, 및상기 폴리사카라이드 및 단백질 항원을 적합한 부형제와 혼합하는 단계를 포함하는, 제1항, 제2항 및 제5항 내지 제9항 중 어느 한 항 기재의 면역원 조성물의 제조 방법.
- 삭제
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PCT/EP2001/010568 WO2002022167A2 (en) | 2000-09-15 | 2001-09-12 | Vaccine against streptococcus penumoniae |
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