BCG Toxicity Study

Solicitation Number: 
S20-083Q
Brief Description: 
The Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), at the National Institutes is investigating recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) as a vaccine for M. tuberculosis when administered via intravenous (IV) route. This solicitation requests support for a toxicity and biodistribution study of a recombinant BCG vaccine. The Subcontractor shall perform Food and Drug Administration (FDA) mandated safety analysis of a recombinant BCG vaccine. The Subcontractor will perform a toxicity study in cannulated Dunkin-Hartley Guinea Pigs. The studies must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The study should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2) and other relevant guidance from FDA and ICH. The Subcontractor shall perform testing according to standard operating procedures (SOP) and approved study protocol to assess the toxicity of the vaccine when delivered intravenously. Toxicity is measured by multiple in-life parameters, gross pathology and histological analysis. This study will also include an analysis of biodistribution and persistence of the BCG in blood and tissues. A draft protocol outline is provided as an attachment. The draft protocol outline and scope are subject to change based on feedback from a pending pre-IND submission. The project scope and objectives will be updated prior to contract execution or via modification if required as a result of FDA feedback. The study will be completed in two parts. The first part will include analysis of animals through study day 90 and will conclude with issuance of an audited draft report of study findings and conclusions. The second part will commence in parallel to the first part and include analysis of animals through study day 180. However, the second part of the study will be terminated upon review and determination of no toxicologically meaningful findings in study part one. At this point, the study report will be finalized. Alternatively, the sponsor/Leidos Biomed may wish to complete full toxicological evaluation of animals through 180 days. In this case, results from both study parts will be included in the final report. The plan as outlined is currently under review and pending concurrence from FDA as part of a pre-IND meeting. Any changes to this approach will be reflected in a modified statement of work. The first dose for this study is targeted for mid/late June 2020.
Vendor Name: 
Leidos Biomedical Research, Inc.
Proposal Due Date: 
Monday, May 4, 2020
Research Category: 
Research & Development Services & Subcontracts
NAICS Codes: 
541380
NCI OA Contract Number: 
HHSN261201500003I - IDIQ
Proposal Instructions: 
Please, contact Subcontracts Administrator Nichole Davis @ nichole.davis@nih.gov to obtain the full solicitation.

Solicitation Updates

Section Modified: Brief Description
Modified By: davisnia
Change Date: 04/03/2020 - 20:41
Original Content: The Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), at the National Institutes is investigating recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) as a vaccine for M. tuberculosis when administered via intravenous (IV) route. This solicitation requests support for a toxicity and biodistribution study of a recombinant BCG vaccine. The Subcontractor shall perform Food and Drug Administration (FDA) mandated safety analysis of a recombinant BCG vaccine. The Subcontractor will perform a toxicity study in cannulated Dunkin-Hartley Guinea Pigs. The studies must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The study should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2) and other relevant guidance from FDA and ICH. The Subcontractor shall perform testing according to standard operating procedures (SOP) and approved study protocol to assess the toxicity of the vaccine when delivered intravenously. Toxicity is measured by multiple in-life parameters, gross pathology and histological analysis. This study will also include an analysis of biodistribution and persistence of the BCG in blood and tissues. A draft protocol outline is provided as an attachment. The draft protocol outline and scope are subject to change based on feedback from a pending pre-IND submission. The project scope and objectives will be updated prior to contract execution or via modification if required as a result of FDA feedback. The study will be completed in two parts. The first part will include analysis of animals through study day 90 and will conclude with issuance of an audited draft report of study findings and conclusions. The second part will commence in parallel to the first part and include analysis of animals through study day 180. However, the second part of the study will be terminated upon review and determination of no toxicologically meaningful findings in study part one. At this point, the study report will be finalized. Alternatively, the sponsor/Leidos Biomed may wish to complete full toxicological evaluation of animals through 180 days. In this case, results from both study parts will be included in the final report. The plan as outlined is currently under review and pending concurrence from FDA as part of a pre-IND meeting. Any changes to this approach will be reflected in a modified statement of work. The first dose for this study is targeted for mid/late June 2020.
Updated Content: The Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), at the National Institutes is investigating recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) as a vaccine for M. tuberculosis when administered via intravenous (IV) route. This solicitation requests support for a toxicity and biodistribution study of a recombinant BCG vaccine. The Subcontractor shall perform Food and Drug Administration (FDA) mandated safety analysis of a recombinant BCG vaccine. The Subcontractor will perform a toxicity study in cannulated Dunkin-Hartley Guinea Pigs. The studies must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The study should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2) and other relevant guidance from FDA and ICH. The Subcontractor shall perform testing according to standard operating procedures (SOP) and approved study protocol to assess the toxicity of the vaccine when delivered intravenously. Toxicity is measured by multiple in-life parameters, gross pathology and histological analysis. This study will also include an analysis of biodistribution and persistence of the BCG in blood and tissues. A draft protocol outline is provided as an attachment. The draft protocol outline and scope are subject to change based on feedback from a pending pre-IND submission. The project scope and objectives will be updated prior to contract execution or via modification if required as a result of FDA feedback. The study will be completed in two parts. The first part will include analysis of animals through study day 90 and will conclude with issuance of an audited draft report of study findings and conclusions. The second part will commence in parallel to the first part and include analysis of animals through study day 180. However, the second part of the study will be terminated upon review and determination of no toxicologically meaningful findings in study part one. At this point, the study report will be finalized. Alternatively, the sponsor/Leidos Biomed may wish to complete full toxicological evaluation of animals through 180 days. In this case, results from both study parts will be included in the final report. The plan as outlined is currently under review and pending concurrence from FDA as part of a pre-IND meeting. Any changes to this approach will be reflected in a modified statement of work. The first dose for this study is targeted for mid/late June 2020.
Section Modified: Brief Description
Modified By: davisnia
Change Date: 04/03/2020 - 20:43
Original Content: The Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), at the National Institutes is investigating recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) as a vaccine for M. tuberculosis when administered via intravenous (IV) route. This solicitation requests support for a toxicity and biodistribution study of a recombinant BCG vaccine. The Subcontractor shall perform Food and Drug Administration (FDA) mandated safety analysis of a recombinant BCG vaccine. The Subcontractor will perform a toxicity study in cannulated Dunkin-Hartley Guinea Pigs. The studies must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The study should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2) and other relevant guidance from FDA and ICH. The Subcontractor shall perform testing according to standard operating procedures (SOP) and approved study protocol to assess the toxicity of the vaccine when delivered intravenously. Toxicity is measured by multiple in-life parameters, gross pathology and histological analysis. This study will also include an analysis of biodistribution and persistence of the BCG in blood and tissues. A draft protocol outline is provided as an attachment. The draft protocol outline and scope are subject to change based on feedback from a pending pre-IND submission. The project scope and objectives will be updated prior to contract execution or via modification if required as a result of FDA feedback. The study will be completed in two parts. The first part will include analysis of animals through study day 90 and will conclude with issuance of an audited draft report of study findings and conclusions. The second part will commence in parallel to the first part and include analysis of animals through study day 180. However, the second part of the study will be terminated upon review and determination of no toxicologically meaningful findings in study part one. At this point, the study report will be finalized. Alternatively, the sponsor/Leidos Biomed may wish to complete full toxicological evaluation of animals through 180 days. In this case, results from both study parts will be included in the final report. The plan as outlined is currently under review and pending concurrence from FDA as part of a pre-IND meeting. Any changes to this approach will be reflected in a modified statement of work. The first dose for this study is targeted for mid/late June 2020.
Updated Content: The Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), at the National Institutes is investigating recombinant Mycobacterium bovis bacillus Calmette-Guérin (BCG) as a vaccine for M. tuberculosis when administered via intravenous (IV) route. This solicitation requests support for a toxicity and biodistribution study of a recombinant BCG vaccine. The Subcontractor shall perform Food and Drug Administration (FDA) mandated safety analysis of a recombinant BCG vaccine. The Subcontractor will perform a toxicity study in cannulated Dunkin-Hartley Guinea Pigs. The studies must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). The study should be performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2) and other relevant guidance from FDA and ICH. The Subcontractor shall perform testing according to standard operating procedures (SOP) and approved study protocol to assess the toxicity of the vaccine when delivered intravenously. Toxicity is measured by multiple in-life parameters, gross pathology and histological analysis. This study will also include an analysis of biodistribution and persistence of the BCG in blood and tissues. A draft protocol outline is provided as an attachment. The draft protocol outline and scope are subject to change based on feedback from a pending pre-IND submission. The project scope and objectives will be updated prior to contract execution or via modification if required as a result of FDA feedback. The study will be completed in two parts. The first part will include analysis of animals through study day 90 and will conclude with issuance of an audited draft report of study findings and conclusions. The second part will commence in parallel to the first part and include analysis of animals through study day 180. However, the second part of the study will be terminated upon review and determination of no toxicologically meaningful findings in study part one. At this point, the study report will be finalized. Alternatively, the sponsor/Leidos Biomed may wish to complete full toxicological evaluation of animals through 180 days. In this case, results from both study parts will be included in the final report. The plan as outlined is currently under review and pending concurrence from FDA as part of a pre-IND meeting. Any changes to this approach will be reflected in a modified statement of work. The first dose for this study is targeted for mid/late June 2020.
Section Modified: Proposal Due Date
Modified By: davisnia
Change Date: 04/03/2020 - 20:41
Original Content: Friday, April 3, 2020
Updated Content: Monday, May 4, 2020
Section Modified: Proposal Instructions
Modified By: davisnia
Change Date: 04/03/2020 - 20:41
Original Content: Please, contact Subcontracts Administrator Nichole Davis @ nichole.davis@nih.gov to obtain the full solicitation.
Updated Content: Please, contact Subcontracts Administrator Nichole Davis @ nichole.davis@nih.gov to obtain the full solicitation.