Authors:
, , , , , , , , , , , , , , , , , and
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-
1
Centers for Disease Control and Prevention, 2002. Yellow fever vaccine; recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 51 :1–10.
-
2
Monath TP, 2001. Yellow fever: an update. Lancet Infect Dis 1 :11–20.
-
3
Robertson SE, 1993. The Immunological Basis for Immunization. Module 8: Yellow Fever. Geneva: World Health Organization, WHO/EPI/GEN/93.18. WHO web site; accessed April 29, 2003. http://www.who.int/vaccines-documents/DocsPDF-IBIe/mod8_e.pdf
-
4
Monath TP, Cetron MS, 2002. Prevention of yellow fever in persons traveling to the tropics. Clin Infect Dis 34 :1369–1378.
-
5
Monath TP, 1999. Yellow fever. Plotkin S, Orenstein WA, eds. Vaccines. Third edition. Philadelphia: W. B. Saunders, 815–880.
-
6
Mortimer PP, 2002. Yellow fever vaccine (editorial). BMJ 324 :439.
-
7
Colebunders R, Mariage JL, Coche JC, Pirenne B, Kempinaire S, Hantson P, Van Gompel A, Niedrig M, van Esbroeck M, Bailey R, Drosten C, Schmitz H, 2002. A Belgian traveler who acquired yellow fever in the Gambia. Clin Infect Dis 35 :e113–e116.
-
8
Centers for Disease Control and Prevention, 2002. Fatal yellow fever in a traveler returning from Amazonas, Brazil, 2002. MMWR Morb Mortal Wkly Rep 51 :324–325.
-
9
Theiler M, Smith HH, 1937. The use of yellow fever virus modified by in vitro cultivation for human immunization. J Exp Med 65 :787.
-
10
WHO, 1987. Production and testing of the WHO yellow fever virus primary seed lot 213-77 and reference batch 168-73. WHO Expert Committee on Biological Standardization. Thirty-Sixth Report. Geneva: Word Health Organization. Annex 6 (WHO Technical Report Series, No. 745).
-
11
WHO, 1976. Requirements for yellow fever vaccine. WHO Expert Committee on Biological Standardization, 27th Report. Geneva: World Health Organization. Annex 1 (WHO Technical Report Series, No 594): 23–49.
-
12
Lang J, Zuckerman J, Clarke P, Barrett P, Kirkpatrick C, Blondeau C, 1999. Comparison of the immunogenicity and safety of two 17D yellow fever vaccines. Am J Trop Med Hyg 60 :1045–1050.
-
13
Monath TP, Nichols R, Archambault WT, Moore L, Marchesani R, Tian J, Shope RE, Thomas N, Schrader R, Furby D, Bedford P, 2002. Comparative safety and immunogenicity of two yellow fever 17D vaccines (ARILVAX and YF-VAX) in a phase III multicenter, double-blind clinical trial. Am J Trop Med Hyg 66 :533–541.
-
14
Jennings AD, Gibson CA, Miller BR, Mathews JH, Mitchell CJ, Roehrig JT, Wood DJ, Taffs F, Sil BK, Whitby SN, 1994. Analysis of a yellow fever virus isolated from a fatal case of vaccine-associated human encephalitis. J Infect Dis 169 :512–518.
-
15
Xie H, Cass AR, Barrett AD, 1998. Yellow fever 17D vaccine virus isolated from healthy vaccinees accumulates very few mutations. Virus Res 55 :93–99.
-
16
Vasconcelos PF, Luna EJ, Galler R, Silva LJ, Coimbra TL, Barros VL, Monath TP, Rodigues SG, Laval C, Costa ZG, Vilela MF, Santos CL, Papaiordanou PM, Alves VA, Andrade LD, Sato HK, Rosa ES, Froguas GB, Lacava E, Almeida LM, Cruz AC, Rocco IM, Santos RT, Oliva OF, Papaiordanou CM, Brazilian Yellow Fever Vaccine Evaluation Group, 2001. Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases. Lancet 358 :91–97.
-
17
Chan RC, Penney DJ, Little D, Carter IW, Roberts JA, Rawlinson WD, 2001. Hepatitis and death following vaccination with 17D-204 yellow fever vaccine. Lancet 358 :121–122.
-
18
Martin M, Tsai TF, Cropp B, Chang GJ, Holmes DA, Tseng J, Shieh W, Zaki SR, Al-Sanouri I, Cutrona AF, Ray G, Weld LH, Cetron MS, 2001. Fever and multisystem organ failure associated with 17D-204 yellow fever vaccination: a report of four cases. Lancet 358 :98–104.
-
19
Centers for Disease Control and Prevention, 2002. Adverse events associated with 17D-derived yellow fever vaccination—United States, 2001–2002. MMWR Morb Mortal Wkly Rep 51 :989–993.
-
20
World Health Organization, 2003. Yellow fever vaccine—WHO position paper. Wkly Epidemiol Rec 78 :349–360.
-
21
Kitchener S, 2004. Viscerotropic and neurotropic disease following vaccination with the 17D yellow fever vaccine, Arilvax. Vaccine 22 :2103–2105.
-
22
Werfel U, Popp W, 2001. Effects of yellow fever vaccination. Lancet 358 :1909.
-
23
Martin M, Weld LH, Tsai TF, Mootrey GT, Chen RT, Niu M, Cetron MS, GeoSentinel Yellow Fever Working Group, 2001. Advanced age a risk factor for illness temporally associated with yellow fever vaccination. Emerg Infect Dis 7 :945–951.
-
24
Mortimer PP, 2002. Yellow fever vaccine: vaccination is necessary despite recent adverse reports. BMJ 324 :439.
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IMMUNOGENICITY AND SAFETY OF BERNA-YF COMPARED WITH TWO OTHER 17D YELLOW FEVER VACCINES IN A PHASE 3 CLINICAL TRIAL
MARKUS PFISTER
MARKUS PFISTER
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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OLIVER KÜRSTEINER
OLIVER KÜRSTEINER
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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HELENE HILFIKER
HELENE HILFIKER
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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DIDIER FAVRE
DIDIER FAVRE
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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PETER DURRER
PETER DURRER
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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ABDALLAH ENNAJI
ABDALLAH ENNAJI
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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JOHANNA L’AGE-STEHR
JOHANNA L’AGE-STEHR
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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ACHIM KAUFHOLD
ACHIM KAUFHOLD
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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CHRISTIAN HERZOG
CHRISTIAN HERZOG
Berna Biotech Ltd., Berne, Switzerland; Hesperion, Allschwil, Switzerland; Robert Koch Institute, Berlin, Germany
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BERNA-YF (Flavimun®) is a live, attenuated yellow fever (YF) vaccine of the 17D strain produced by Berna Biotech Ltd. following a transfer of technology from the Robert Koch Institute (RKI) in Berlin, Germany. In this phase 3 bridging study, the immunogenicity and safety of BERNA-YF were compared with the original RKI YF vaccine (RKI-YF) and to a current, commercially available YF vaccine, Stamaril® (AP-YF; Aventis Pasteur, Lyon, France), in 304 healthy, adult volunteers. All three vaccines elicited an effective immune response with seroprotection achieved in 100% of individuals in each vaccine group at a neutralizing antibody titer ≥ 1:10. BERNA-YF was shown to be comparable to the other two vaccine products, and subgroup analysis showed no differences in immune response between three consecutive production batches. The immune response to BERNA-YF and RKI-YF was very similar, with no significant difference in antibody titer between the two groups (P = 0.4634). However, AP-YF vaccination resulted in a significantly lower antibody titer (P < 0.0001 versus BERNA-YF). Males exhibited a higher antibody response than females to both BERNA-YF and RKI-YF, but not to AP-YF. All three vaccines were well tolerated and no serious adverse events were reported.
Author Notes
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1
Centers for Disease Control and Prevention, 2002. Yellow fever vaccine; recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 51 :1–10.
-
2
Monath TP, 2001. Yellow fever: an update. Lancet Infect Dis 1 :11–20.
-
3
Robertson SE, 1993. The Immunological Basis for Immunization. Module 8: Yellow Fever. Geneva: World Health Organization, WHO/EPI/GEN/93.18. WHO web site; accessed April 29, 2003. http://www.who.int/vaccines-documents/DocsPDF-IBIe/mod8_e.pdf
-
4
Monath TP, Cetron MS, 2002. Prevention of yellow fever in persons traveling to the tropics. Clin Infect Dis 34 :1369–1378.
-
5
Monath TP, 1999. Yellow fever. Plotkin S, Orenstein WA, eds. Vaccines. Third edition. Philadelphia: W. B. Saunders, 815–880.
-
6
Mortimer PP, 2002. Yellow fever vaccine (editorial). BMJ 324 :439.
-
7
Colebunders R, Mariage JL, Coche JC, Pirenne B, Kempinaire S, Hantson P, Van Gompel A, Niedrig M, van Esbroeck M, Bailey R, Drosten C, Schmitz H, 2002. A Belgian traveler who acquired yellow fever in the Gambia. Clin Infect Dis 35 :e113–e116.
-
8
Centers for Disease Control and Prevention, 2002. Fatal yellow fever in a traveler returning from Amazonas, Brazil, 2002. MMWR Morb Mortal Wkly Rep 51 :324–325.
-
9
Theiler M, Smith HH, 1937. The use of yellow fever virus modified by in vitro cultivation for human immunization. J Exp Med 65 :787.
-
10
WHO, 1987. Production and testing of the WHO yellow fever virus primary seed lot 213-77 and reference batch 168-73. WHO Expert Committee on Biological Standardization. Thirty-Sixth Report. Geneva: Word Health Organization. Annex 6 (WHO Technical Report Series, No. 745).
-
11
WHO, 1976. Requirements for yellow fever vaccine. WHO Expert Committee on Biological Standardization, 27th Report. Geneva: World Health Organization. Annex 1 (WHO Technical Report Series, No 594): 23–49.
-
12
Lang J, Zuckerman J, Clarke P, Barrett P, Kirkpatrick C, Blondeau C, 1999. Comparison of the immunogenicity and safety of two 17D yellow fever vaccines. Am J Trop Med Hyg 60 :1045–1050.
-
13
Monath TP, Nichols R, Archambault WT, Moore L, Marchesani R, Tian J, Shope RE, Thomas N, Schrader R, Furby D, Bedford P, 2002. Comparative safety and immunogenicity of two yellow fever 17D vaccines (ARILVAX and YF-VAX) in a phase III multicenter, double-blind clinical trial. Am J Trop Med Hyg 66 :533–541.
-
14
Jennings AD, Gibson CA, Miller BR, Mathews JH, Mitchell CJ, Roehrig JT, Wood DJ, Taffs F, Sil BK, Whitby SN, 1994. Analysis of a yellow fever virus isolated from a fatal case of vaccine-associated human encephalitis. J Infect Dis 169 :512–518.
-
15
Xie H, Cass AR, Barrett AD, 1998. Yellow fever 17D vaccine virus isolated from healthy vaccinees accumulates very few mutations. Virus Res 55 :93–99.
-
16
Vasconcelos PF, Luna EJ, Galler R, Silva LJ, Coimbra TL, Barros VL, Monath TP, Rodigues SG, Laval C, Costa ZG, Vilela MF, Santos CL, Papaiordanou PM, Alves VA, Andrade LD, Sato HK, Rosa ES, Froguas GB, Lacava E, Almeida LM, Cruz AC, Rocco IM, Santos RT, Oliva OF, Papaiordanou CM, Brazilian Yellow Fever Vaccine Evaluation Group, 2001. Serious adverse events associated with yellow fever 17DD vaccine in Brazil: a report of two cases. Lancet 358 :91–97.
-
17
Chan RC, Penney DJ, Little D, Carter IW, Roberts JA, Rawlinson WD, 2001. Hepatitis and death following vaccination with 17D-204 yellow fever vaccine. Lancet 358 :121–122.
-
18
Martin M, Tsai TF, Cropp B, Chang GJ, Holmes DA, Tseng J, Shieh W, Zaki SR, Al-Sanouri I, Cutrona AF, Ray G, Weld LH, Cetron MS, 2001. Fever and multisystem organ failure associated with 17D-204 yellow fever vaccination: a report of four cases. Lancet 358 :98–104.
-
19
Centers for Disease Control and Prevention, 2002. Adverse events associated with 17D-derived yellow fever vaccination—United States, 2001–2002. MMWR Morb Mortal Wkly Rep 51 :989–993.
-
20
World Health Organization, 2003. Yellow fever vaccine—WHO position paper. Wkly Epidemiol Rec 78 :349–360.
-
21
Kitchener S, 2004. Viscerotropic and neurotropic disease following vaccination with the 17D yellow fever vaccine, Arilvax. Vaccine 22 :2103–2105.
-
22
Werfel U, Popp W, 2001. Effects of yellow fever vaccination. Lancet 358 :1909.
-
23
Martin M, Weld LH, Tsai TF, Mootrey GT, Chen RT, Niu M, Cetron MS, GeoSentinel Yellow Fever Working Group, 2001. Advanced age a risk factor for illness temporally associated with yellow fever vaccination. Emerg Infect Dis 7 :945–951.
-
24
Mortimer PP, 2002. Yellow fever vaccine: vaccination is necessary despite recent adverse reports. BMJ 324 :439.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1300 | 1067 | 111 |
| Full Text Views | 487 | 10 | 0 |
| PDF Downloads | 154 | 13 | 0 |