Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine
•The live RSV vaccine virus was primarily detected in young children post dose 1.•About half of the shed vaccine viruses (13/24) contained sequence changes.•These sequence changes may result in lower RSVF protein expression.•These changes may have been selected during replication in humans.•The pres...
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| Published in | Vaccine Vol. 31; no. 26; pp. 2822 - 2827 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kidlington
Elsevier Ltd
10.06.2013
Elsevier Elsevier Limited |
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| Online Access | Get full text |
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| Abstract | •The live RSV vaccine virus was primarily detected in young children post dose 1.•About half of the shed vaccine viruses (13/24) contained sequence changes.•These sequence changes may result in lower RSVF protein expression.•These changes may have been selected during replication in humans.•The presence of vaccine variants may be associated with lower RSVF sero-responses.
MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 104, 105 and 106TCID50. After 3 doses of MEDI-534 at 106TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. |
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| AbstractList | MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 104, 105 and 106TCID50. After 3 doses of MEDI-534 at 106TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. •The live RSV vaccine virus was primarily detected in young children post dose 1.•About half of the shed vaccine viruses (13/24) contained sequence changes.•These sequence changes may result in lower RSVF protein expression.•These changes may have been selected during replication in humans.•The presence of vaccine variants may be associated with lower RSVF sero-responses. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 104, 105 and 106TCID50. After 3 doses of MEDI-534 at 106TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 10⁴, 10⁵ and 10⁶TCID₅₀. After 3 doses of MEDI-534 at 10⁶TCID₅₀, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 104, 105and 106TCID50. After 3 doses of MEDI-534 at 106TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 10(4), 10(5) and 10(6)TCID50. After 3 doses of MEDI-534 at 10(6)TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study.MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 10(4), 10(5) and 10(6)TCID50. After 3 doses of MEDI-534 at 10(6)TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. Highlights • The live RSV vaccine virus was primarily detected in young children post dose 1. • About half of the shed vaccine viruses (13/24) contained sequence changes. • These sequence changes may result in lower RSVF protein expression. • These changes may have been selected during replication in humans. • The presence of vaccine variants may be associated with lower RSVF sero-responses. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 104, 105 and 106 TCID50. After 3 doses of MEDI-534 at 106 TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 10 super(4), 10 super(5) and 10 super(6) TCID sub(50). After 3 doses of MEDI-534 at 10 super(6) TCID sub(50), administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to P1V3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed times 2.5% variants with low or no RSV F expression while single nucleotide primer extension detected similar to 1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. MEDI-534 is the first live vectored RSV vaccine candidate to be evaluated in seronegative children. It consists of the bovine parainfluenza virus type 3 (PIV3) genome with substituted human PIV3 F and HN glycoproteins engineered to express RSV F protein. A Phase 1 study of 49 healthy RSV and PIV3 seronegative children 6 to <24 months of age demonstrated an acceptable safety profile at the following doses: 10(4), 10(5) and 10(6)TCID50. After 3 doses of MEDI-534 at 10(6)TCID50, administered at 0, 2 and 4 month intervals, 100% of subjects seroresponded to PIV3, whereas only 50% seroresponded to RSV. To investigate the discordance in seroresponse rates, the RSV F transgene and its flanking non-coding nucleotides were sequenced from shed virus recovered from the nasal washes of 24 MEDI-534-vaccinated children. Eleven out of 24 samples contained no nucleotide changes in the analyzed region. The other 13 samples contained mixtures of variant subpopulations. Fifty-five percent exhibited changes in the transcription termination poly A gene sequences of the upstream bPIV3N gene while 21% had variant subpopulations in the RSV F open reading frame that resulted in pre-mature stop codons. Both types of changes are expected to reduce RSV F expression. Evaluation of the administered vaccine by dual immunofluorescence staining showed ~2.5% variants with low or no RSV F expression while single nucleotide primer extension detected ~1% variation at nucleotide 2045 that resulted in a pre-mature translational termination at codon 85. An association between shedding of variants and lower RSV F serological response was observed but it was not possible to establish a definitive clinical significance due to the small number of subjects in this study. |
| Author | Galinski, Mark S. Wang, C. Kathy Zuo, Fengrong Schickli, Jeanne H. Tang, Roderick S. Malkin, Elissa Dubovsky, Filip Yang, Chin-Fen Shambaugh, Cindy |
| Author_xml | – sequence: 1 givenname: Chin-Fen surname: Yang fullname: Yang, Chin-Fen email: yangc@medimmune.com, cyang01003@gmail.com organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States – sequence: 2 givenname: C. Kathy surname: Wang fullname: Wang, C. Kathy organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States – sequence: 3 givenname: Elissa surname: Malkin fullname: Malkin, Elissa organization: MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States – sequence: 4 givenname: Jeanne H. surname: Schickli fullname: Schickli, Jeanne H. organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States – sequence: 5 givenname: Cindy surname: Shambaugh fullname: Shambaugh, Cindy organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States – sequence: 6 givenname: Fengrong surname: Zuo fullname: Zuo, Fengrong organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States – sequence: 7 givenname: Mark S. surname: Galinski fullname: Galinski, Mark S. organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States – sequence: 8 givenname: Filip surname: Dubovsky fullname: Dubovsky, Filip organization: MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States – sequence: 9 givenname: Roderick S. surname: Tang fullname: Tang, Roderick S. organization: MedImmune, 297 North Bernardo Avenue, Mountain View, CA 94043, United States |
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| ContentType | Journal Article |
| Copyright | 2013 Elsevier Ltd Elsevier Ltd 2014 INIST-CNRS Copyright © 2013 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Jun 10, 2013 |
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| DOI | 10.1016/j.vaccine.2013.04.006 |
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| Keywords | Virus variants Respiratory syncytial virus (RSV) RSV F expression Immunogenicity Human Retroviridae Vaccine Virus Human syncytial virus Spumavirus Phase I trial Attenuated strain Child Vector |
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| References_xml | – volume: 375 start-page: 1545 year: 2010 end-page: 1555 ident: bib0035 article-title: Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis publication-title: Lancet – volume: 31 start-page: 109 year: 2012 end-page: 114 ident: bib0005 article-title: Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children publication-title: Pediatr Infect Dis J – volume: 21 start-page: 3479 year: 2003 end-page: 3482 ident: bib0045 article-title: Correlates of immunity to respiratory syncytial virus (RSV) associated-hospitalization: establishment of minimum protective threshold levels of serum neutralizing antibodies publication-title: Vaccine – volume: 78 start-page: 11198 year: 2004 end-page: 11207 ident: bib0065 article-title: Parainfluenza virus type 3 expressing the native or soluble fusion (F) protein of respiratory syncytial virus (RSV) confers protection from RSV infection in African green monkeys publication-title: J Virol – reference: Nelson CA, Tang RS, Stillman E. Genetic stability of RSV-F expression and the restricted growth phenotype of a live attenuated PIV3 vectored RSV vaccine candidate (MEDI-534) following restrictive growth in human lung cells. 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I: Disease pathogenesis and early attempts at prevention publication-title: Adv Ther doi: 10.1007/s12325-010-0100-z – volume: 191 start-page: 1116 issue: 7 year: 2005 ident: 10.1016/j.vaccine.2013.04.006_bib0010 article-title: A bovine parainfluenza virus type 3 vaccine is safe and immunogenic in early infancy publication-title: J Infect Dis doi: 10.1086/428092 – volume: 2 start-page: 1523 year: 2010 ident: 10.1016/j.vaccine.2013.04.006_bib0050 article-title: Respiratory syncytial virus: a prioritized or neglected target? publication-title: Future Med Chem doi: 10.4155/fmc.10.235 – volume: 198 start-page: 1007 issue: 7 year: 2008 ident: 10.1016/j.vaccine.2013.04.006_bib0060 article-title: Young infants can develop protective levels of neutralizing antibody after infection with respiratory syncytial virus publication-title: J Infect Dis doi: 10.1086/591460 – volume: 31 start-page: 109 issue: 2 year: 2012 ident: 10.1016/j.vaccine.2013.04.006_bib0005 article-title: Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children publication-title: Pediatr Infect Dis J doi: 10.1097/INF.0b013e31823386f1 – volume: 360 start-page: 588 issue: 6 year: 2009 ident: 10.1016/j.vaccine.2013.04.006_bib0020 article-title: The burden of respiratory syncytial virus infection in young children publication-title: N Engl J Med doi: 10.1056/NEJMoa0804877 – volume: 78 start-page: 11198 issue: 20 year: 2004 ident: 10.1016/j.vaccine.2013.04.006_bib0065 article-title: Parainfluenza virus type 3 expressing the native or soluble fusion (F) protein of respiratory syncytial virus (RSV) confers protection from RSV infection in African green monkeys publication-title: J Virol doi: 10.1128/JVI.78.20.11198-11207.2004 |
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| Title | Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine |
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