Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions
Two HIV-1 subtype C gp120 protein candidates were the selected antigens for several experimental vaccine regimens now under evaluation in HVTN 100 Phase I/II clinical trial aiming to support the start of the HVTN 702 Phase IIb/III trial in southern Africa, which is designed to confirm and extend the...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2016-05-01
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| Series: | Vaccines |
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| Online Access: | http://www.mdpi.com/2076-393X/4/2/17 |
| _version_ | 1818036965765808128 |
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| author | Zihao Wang Clarisse Lorin Marguerite Koutsoukos David Franco Babak Bayat Ying Zhang Andrea Carfi Susan W. Barnett Frederick Porter |
| author_facet | Zihao Wang Clarisse Lorin Marguerite Koutsoukos David Franco Babak Bayat Ying Zhang Andrea Carfi Susan W. Barnett Frederick Porter |
| author_sort | Zihao Wang |
| collection | DOAJ |
| description | Two HIV-1 subtype C gp120 protein candidates were the selected antigens for several experimental vaccine regimens now under evaluation in HVTN 100 Phase I/II clinical trial aiming to support the start of the HVTN 702 Phase IIb/III trial in southern Africa, which is designed to confirm and extend the partial protection seen against HIV-1 infection in the RV144 Thai trial. Here, we report the comprehensive physicochemical characterization of the gp120 reference materials that are representative of the clinical trial materials. Gp120 proteins were stably expressed in Chinese Hamster Ovary (CHO) cells and subsequently purified and formulated. A panel of analytical techniques was used to characterize the physicochemical properties of the two protein molecules. When formulated in the AS01 Adjuvant System, the bivalent subtype C gp120 antigens elicited 1086.C- and TV1.C-specific binding antibody and CD4+ T cell responses in mice. All the characteristics were highly representative of the Clinical Trial Materials (CTM). Data from this report demonstrate the immunogenicity of the gp120 antigens, provide comprehensive characterization of the molecules, set the benchmark for assessment of current and future CTM lots, and lay the physicochemical groundwork for interpretation of future clinical trial data. |
| first_indexed | 2024-12-10T07:19:20Z |
| format | Article |
| id | doaj.art-84d9a0f80d4b4066b1c89084392fde7f |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-12-10T07:19:20Z |
| publishDate | 2016-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-84d9a0f80d4b4066b1c89084392fde7f2022-12-22T01:57:51ZengMDPI AGVaccines2076-393X2016-05-01421710.3390/vaccines4020017vaccines4020017Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African RegionsZihao Wang0Clarisse Lorin1Marguerite Koutsoukos2David Franco3Babak Bayat4Ying Zhang5Andrea Carfi6Susan W. Barnett7Frederick Porter8GSK Vaccines, 7030 Kit Creek Road, Morrisville, NC 27560, USAGSK Vaccines, 1330 Rixensart, BelgiumGSK Vaccines, 1330 Rixensart, BelgiumGSK Vaccines, 1330 Rixensart, BelgiumGSK Vaccines, 1330 Rixensart, BelgiumGSK Vaccines, 7030 Kit Creek Road, Morrisville, NC 27560, USAGSK Vaccines, Cambridge, MA 02139, USAGSK Vaccines, Cambridge, MA 02139, USAGSK Vaccines, 7030 Kit Creek Road, Morrisville, NC 27560, USATwo HIV-1 subtype C gp120 protein candidates were the selected antigens for several experimental vaccine regimens now under evaluation in HVTN 100 Phase I/II clinical trial aiming to support the start of the HVTN 702 Phase IIb/III trial in southern Africa, which is designed to confirm and extend the partial protection seen against HIV-1 infection in the RV144 Thai trial. Here, we report the comprehensive physicochemical characterization of the gp120 reference materials that are representative of the clinical trial materials. Gp120 proteins were stably expressed in Chinese Hamster Ovary (CHO) cells and subsequently purified and formulated. A panel of analytical techniques was used to characterize the physicochemical properties of the two protein molecules. When formulated in the AS01 Adjuvant System, the bivalent subtype C gp120 antigens elicited 1086.C- and TV1.C-specific binding antibody and CD4+ T cell responses in mice. All the characteristics were highly representative of the Clinical Trial Materials (CTM). Data from this report demonstrate the immunogenicity of the gp120 antigens, provide comprehensive characterization of the molecules, set the benchmark for assessment of current and future CTM lots, and lay the physicochemical groundwork for interpretation of future clinical trial data.http://www.mdpi.com/2076-393X/4/2/17vaccineantigensgp120HIV-1clinical trialcharacterizationimmunogenicity |
| spellingShingle | Zihao Wang Clarisse Lorin Marguerite Koutsoukos David Franco Babak Bayat Ying Zhang Andrea Carfi Susan W. Barnett Frederick Porter Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions Vaccines vaccine antigens gp120 HIV-1 clinical trial characterization immunogenicity |
| title | Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions |
| title_full | Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions |
| title_fullStr | Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions |
| title_full_unstemmed | Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions |
| title_short | Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions |
| title_sort | comprehensive characterization of reference standard lots of hiv 1 subtype c gp120 proteins for clinical trials in southern african regions |
| topic | vaccine antigens gp120 HIV-1 clinical trial characterization immunogenicity |
| url | http://www.mdpi.com/2076-393X/4/2/17 |
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