Safety and Immunogenicity Trial in Adult Volunteers of a Human Papillomavirus 16 L1 Virus-Like Particle Vaccine
Background: Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a...
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| Published in | JNCI : Journal of the National Cancer Institute Vol. 93; no. 4; pp. 284 - 292 |
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| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Cary, NC
Oxford University Press
21.02.2001
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0027-8874 1460-2105 |
| DOI | 10.1093/jnci/93.4.284 |
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| Abstract | Background: Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults. Methods: Volunteers were given intramuscular injections with placebo or with 10- or 50-μg doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPV16 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided. Results: The prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40–640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10 240 (1499 to 69 938) without adjuvant, 10 240 (1114 to 94 145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation = .85), confirming that ELISA titers are valid proxies for neutralizing antibodies. Conclusions: The HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection. |
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| AbstractList | Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults. Volunteers were given intramuscular injections with placebo or with 10- or 50- mu g doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPVI6 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided. The prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40-640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10240 (1499 to 69938) without adjuvant, 10240 (1114 to 94145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation = .85), confirming that ELISA titers are valid proxies for neutralizing antibodies. The HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection. Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults.BACKGROUNDStudies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults.Volunteers were given intramuscular injections with placebo or with 10- or 50-microg doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPV16 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided.METHODSVolunteers were given intramuscular injections with placebo or with 10- or 50-microg doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPV16 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided.The prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40--640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10,240 (1499 to 69 938) without adjuvant, 10,240 (1114 to 94 145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation =.85), confirming that ELISA titers are valid proxies for neutralizing antibodies.RESULTSThe prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40--640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10,240 (1499 to 69 938) without adjuvant, 10,240 (1114 to 94 145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation =.85), confirming that ELISA titers are valid proxies for neutralizing antibodies.The HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection.CONCLUSIONSThe HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection. Background: Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults. Methods: Volunteers were given intramuscular injections with placebo or with 10- or 50-μg doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPV16 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided. Results: The prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40–640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10 240 (1499 to 69 938) without adjuvant, 10 240 (1114 to 94 145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation = .85), confirming that ELISA titers are valid proxies for neutralizing antibodies. Conclusions: The HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection. Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults. Volunteers were given intramuscular injections with placebo or with 10- or 50-microg doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPV16 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided. The prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40--640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10,240 (1499 to 69 938) without adjuvant, 10,240 (1114 to 94 145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation =.85), confirming that ELISA titers are valid proxies for neutralizing antibodies. The HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection. |
| Author | Mast, T. Christopher Robinson, Robin Roden, Richard B. S. Hildesheim, Allan Dillner, Joakim Harro, Clayton D. Wang, Zhaohui Karron, Ruth A. Lowy, Douglas R. Pang, Yuk-Ying Susana Schiller, John T. Reynolds, Mary Jane Murphy, Brian R. |
| Author_xml | – sequence: 1 givenname: Clayton D. surname: Harro fullname: Harro, Clayton D. organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 2 givenname: Yuk-Ying Susana surname: Pang fullname: Pang, Yuk-Ying Susana organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 3 givenname: Richard B. S. surname: Roden fullname: Roden, Richard B. S. organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 4 givenname: Allan surname: Hildesheim fullname: Hildesheim, Allan organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 5 givenname: Zhaohui surname: Wang fullname: Wang, Zhaohui organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 6 givenname: Mary Jane surname: Reynolds fullname: Reynolds, Mary Jane organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 7 givenname: T. Christopher surname: Mast fullname: Mast, T. Christopher organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 8 givenname: Robin surname: Robinson fullname: Robinson, Robin organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 9 givenname: Brian R. surname: Murphy fullname: Murphy, Brian R. organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 10 givenname: Ruth A. surname: Karron fullname: Karron, Ruth A. organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 11 givenname: Joakim surname: Dillner fullname: Dillner, Joakim organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 12 givenname: John T. surname: Schiller fullname: Schiller, John T. organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda – sequence: 13 givenname: Douglas R. surname: Lowy fullname: Lowy, Douglas R. organization: Affiliations of authors: C. D. Harro, M. J. Reynolds, T. C. Mast, R. A. Karron (Center for Immunization Research, Department of International Medicine, School of Hygiene and Public Health), R. B. S. Roden (Department of Pathology, School of Medicine), The Johns Hopkins University, Baltimore, MD; Y.-Y. S. Pang, J. T. Schiller, D. R. Lowy (Laboratory of Cellular Oncology, Division of Basic Sciences), A. Hildesheim (Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics), National Cancer Institute, Bethesda, MD; Z. Wang, J. Dillner, Microbiology and Tumor Biology Centre, Karolinska Institute, Stockholm, Sweden; R. Robinson, Novavax, Inc., Columbia, MD; B. R. Murphy, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda |
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| Issue | 4 |
| Keywords | Human Healthy subject Virus like particle Vaccine Papovaviridae Harmlessness Papillomavirus Virus Increasing dose Human papillomavirus 16 Human papillomavirus Immunogenicity Double blind study Adult Clinical trial |
| Language | English |
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| Notes | ark:/67375/HXZ-P87ZC31T-4 local:0930284 Correspondence to: Douglas R. Lowy, M.D., National Institutes of Health, Bldg. 36, Rm. 1D-32, Bethesda, MD 20892 (e-mail: drl@helix.nih.gov). istex:4D7E00D29321F970D4DF46EA399DC8DDDCE13E33 PII:1460-2105 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
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| References | Roden (20_15938076) 1995; 69 Langenberg (34_15880764) 1995; 122 (36_38775471) 1997; 176 Heineman (35_10915805) 1999; 17 Roden (26_16324720) 1996; 70 Christensen (23_15676591) 1994; 205 Zhang (31_6396317) 2000; 18 Breitburd (14_15870594) 1995; 69 Kirnbauer (10_10075688) 1992; 89 (25_38578613) 2000; 181 Pisani (2_10930320) 1999; 83 Suzich (16_16113137) 1995; 92 Walboomers (7_10932262) 1999; 189 Kirnbauer (11_14504218) 1993; 67 Nardelli-Haefliger (30_10992153) 1999; 73 Kirnbauer (17_16211622) 1996; 219 Roden (22_16846157) 1997; 71 Christensen (15_16145806) 1996; 70 (24_38737005) 1995; 172 Christensen (21_16397480) 1996; 223 Robinson (19_5900467) 1998; 12 Chang (9_16807003) 1997; 336 Judd (40_4783016) 1979; 115 Rose (13_10161720) 1993; 67 Parkin (1_10747736) 1999; 80 Bachmann (39_16578271) 1996; 17 Bosch (6_15916356) 1995; 87 Luckow (18_10295758) 1993; 67 Kurman (3_15502656) 1994; 271 Schiller (8_16623500) 1996; 7 Scolnick (32_13204877) 1984; 251 Wiedermann (33_14299296) 1987; 5 11181763 - J Natl Cancer Inst. 2001 Feb 21;93(4):252-3 |
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| Snippet | Background: Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major... Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral... |
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| SubjectTerms | Adjuvants, Immunologic - administration & dosage Adult Alum Compounds - administration & dosage Antibodies, Viral - blood Applied microbiology Baculoviridae Biological and medical sciences clinical trials Double-Blind Method Enzyme-Linked Immunosorbent Assay Female Fundamental and applied biological sciences. Psychology Human papillomavirus 16 Humans immune response Immunization Schedule immunogenicity Immunoglobulins - blood Injections, Intramuscular Male Microbiology Papillomaviridae - immunology Papillomavirus Vaccines Polysorbates - administration & dosage Recombinant Proteins Reference Values Squalene - administration & dosage vaccines Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Viral Vaccines - administration & dosage Viral Vaccines - adverse effects Viral Vaccines - immunology |
| Title | Safety and Immunogenicity Trial in Adult Volunteers of a Human Papillomavirus 16 L1 Virus-Like Particle Vaccine |
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