SOURCES SOUGHT
B -- Continued Follow-up of HPV Type 16 Vaccinated Cohorts and Preparation for the Implementation of a New One-dose Trial
- Notice Date
- 2/8/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-SS-ETSB-1010-59
- Archive Date
- 3/2/2016
- Point of Contact
- Corwin Stephens, Phone: 240-276-5362, Jill Johnson, Phone: 240-276-5395
- E-Mail Address
-
corwin.stephens@nih.gov, jill.johnson2@nih.gov
(corwin.stephens@nih.gov, jill.johnson2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." BACKGROUND The NCI-funded Costa Rica Vaccine Trial (CVT), was a community-based, double-blind, randomized controlled phase III trial of the bivalent GlaxoSmithKline (GSK) vaccine. The study enrolled 7,466 young women between 2004 and 2005 residing in the regions of Guanacaste and Puntarenas, Costa Rica, identified via a census. The main eligibility requirements were ages between 18-25 years old, good general health, and neither pregnant nor breastfeeding. Women were excluded if they had pre-existing medical conditions that preclude vaccination, had history of hepatitis A or previous vaccination against it, or were unwilling to use contraception during the vaccination period. At the enrollment visit and following informed consent, a risk factor interview was administered, a pelvic examination was performed on sexually experienced women, exfoliated cells were collected in PreservCyt liquid medium for ThinPrep cytologic evaluation and HPV DNA testing, and blood was collected. Then, women were randomized in a double-blinded fashion to receive Cervarix or a "Control" hepatitis A vaccine (HAV arm; modified preparation of Havrix, GSK Biologicals). Both vaccines had identical packaging and were intended to be administered at 0, 1, and 6 months. Women not vaccinated in the allowable ranges did not receive the dose. Women who became pregnant during the vaccination phase or were referred to colposcopy were deferred; if the vaccination window was missed, then she missed that specific dose. Women were followed annually for 4 years, or every 6 months if they had low-grade cytologic abnormalities. At follow-up visits, a risk factor questionnaire was administered, a pelvic exam for cervical cancer screening was performed, and cervical cells and blood were collected. Women with evidence of high-grade disease or with persistent low-grade abnormalities were referred to colposcopy for evaluation and treatment, when needed. Given that some women received fewer than three doses of the assigned vaccine, we were able to investigate the dose-specific vaccine efficacy. We observed that efficacy was similar after four years, regardless of the number of doses received. This study provided the first published efficacy data for fewer than three doses. New published data on reduced-dose protection has come from immunogenicity studies, which support the Costa Rica findings. PURPOSE AND OBJECTIVES The requirements of this new prospective contract are related to NCI's HPV vaccine evaluation efforts required for the next phase of this HPV vaccine research in Costa Rica, and will cover two projects: 1) transition of women in from the original Costa Rica HPV Vaccine Trial into either an additional follow-up phase or completion of study and 2) planning for a new trial aimed at evaluating the efficacy of 1 versus 2 doses of the HPV vaccines. Additional work is needed to finalize participation for the subset of participants who are not in the follow-up research group of interest, and transition those who will continue to be studied in the next phase of the research which will explore the durability of vaccine protection beyond 10 years. Further, because the Costa Rica HPV Vaccine Trial showed similar HPV vaccine efficacy over four years among women who received one, two and three doses of the HPV16/18 vaccine, and stable antibody responses have been observed throughout the seven years of follow-up accrued to date in CVT, following up on these discoveries and further documenting the protection afforded by fewer doses could result in a monumental, global public health breakthrough. Thus, the second component of the study involves the planning phase of a new trial that will directly evaluate the protection afforded by single-dose and two- dose regimens of the prophylactic HPV vaccines. PROJECT REQUIREMENTS Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the following activities as specified by the NCI Contracting Officer Representative (COR) to conduct the Transition of the women participating of the Human Papillomavirus Type 16 Vaccine Trial in Costa Rica to extended follow-up or exiting the study and prepare for the implementation of the One-dose trial. Task 1: Transition of women in the original CVT into either an extended follow-up or study completion Activity No. 1: Liaison The Contractor shall: a) Update approvals and clearances from the collaborating institutions and appropriate agencies within each community in which the investigation occurs. This includes local institutional review board clearances, Costa Rica Ministry of Health approvals, and any other scientific, administrative, or ethical approvals required. b) Assist in arranging communications or meetings as needed, including those between the NCI research investigators and the collaborating hospitals, screening centers, laboratories, and/or agencies for those parties whose cooperation or approval is necessary. Attend and report on such meetings, provide all background material required, and take action on recommendations in consultation with the COR. c) Conduct educational, information, and public health promotion campaigns in the local Costa Rican community to inform the population of the study and its findings to date, as needed, to maintain good stature in the community. Activity No. 2: Preparation of Study Materials and Forms. The Contractor shall: a) Assist in the modification of existing forms as indicated by the ongoing study, as well as the development of any new materials needed for the study. This shall include informational brochures, questionnaires, and other study forms. b) Translate these materials from English to Spanish and/or from Spanish to English, as required. Activity No. 3: Follow-up of Study Participants The Contractor shall: a) Collect specimens from participants at the time of study visits as requested by the NCI COR. b) During the transition phase, ensure that participants with cytological evidence of high-grade cervical or anal disease be seen for colposcopy/anoscopy as needed. The criteria for referral to colposcopy/anoscopy shall be approved by the NCI COR. At the time of the visit, specimen collection, biopsy and treatment procedures shall be performed as agreed upon by the clinician and the NCI COR. c) Ensure that biological specimens collected from participants are sent to a qualified laboratory for processing and testing, as specified by the NCI COR. d) Provide adequate referral to the Costa Rican national health care system for the treatment of conditions diagnosed at the time of a clinical examination. e) Document all contacts with study participants using study-specific forms. These forms shall be carefully maintained in medical record charts or electronic files as needed. Activity No. 4: Data Preparation and Entry The Contractor shall: a) Prior to keying, all completed study forms and materials shall be reviewed for accuracy and coded, as needed. b) All study forms shall be keyed into a data management system developed specifically for this study. Activity No. 5: Maintenance of Data Management System The Contractor shall: a) Implement ancillary IT components needed for the study, and maintain and expand the current network of computers and the data management system. b) Ensure appropriate day to day management of the local data and provide adequate disaster, back-up and recovery mechanisms to ensure that data are not lost. Activity No. 6: Processing, Storage, and Testing of Biological Specimens The Contractor shall: a) Process and store biological specimens collected as part of this study. This will include but not limited to processing blood into its various components within a few hours of collection, preparing cytology specimens, and adequately preserving tissue specimens when applicable. Procedures implemented for these purposes shall be approved by the NCI COR. b) Perform various laboratory tests utilizing biological specimens collected from participants, as requested by the NCI COR. This shall include but not be limited to HPV DNA detection tests for clinical management during the transition phase. These tests shall be performed as specified by the NCI COR. Activity No. 7: Retrieval of Pathological Specimens The Contractor shall: a) Retrieve specified cervical pathological specimens (slides and blocks) obtained from study participants when indicated. Activity No. 8: Shipment of Study Forms and Biological Specimens The Contractor shall: a) Ship and track biological specimens to the Frederick National Laboratories in the United States. This will include shipments at room temperature and in frozen states (including dry ice and liquid nitrogen). Activity No. 9: Study Monitoring, Quality Control and Reporting Quality control shall require that the Contractor: a) Document each step in the study and maintain, in an orderly arrangement, all relevant material so that any aspect of the study may be reviewed and evaluated by the NCI COR at any point in time. b) Employ internal record-keeping procedures for assessing the progress and status of data collection, preparation, and entry. This shall include but not be limited to careful maintenance of a log of decisions made during the course of the study and the development of range and logic edits as needed to ensure data quality. c) Utilize internal audit and performance review procedures. This shall include but not be limited to well thought out plans for resolving problems uncovered during routine audits by the principal investigators and study coordinators, providing incentives for exceptional staff members, and assuring retraining and possible dismissal of staff members performing at unacceptable levels. d) Monitor and document the performance and progress of any work done under subcontract. e) Use applicable and common security practices for protecting data collected. f) Develop and practice quality control procedures for the handling of biological specimens collected. g) Update the data management system in a timely manner to assure rapid and timely access by the NCI COR to study data. h)Provide monthly, annual, and final technical progress reports, as requested by the NCI COR and/or designated representative. Activity No. 10: Final Transition at the completion of the contract The Contractor shall: a) Develop and implement a Final Transition Plan to ensure the orderly, efficient, and smooth transition of all contract activities and materials to the COR at the end of the contract period. Within six (6) months of the completion date of the study, a Draft Final Transition Plan will be submitted to the COR for review. The Draft Final Transition Plan should include details on the secure transfer of all data files and study materials to the COR by the end of the contract. The Final Transition Plan will be submitted to the COR no later than four (4) months prior to the completion date of the study. Task 2: Planning for the One-dose trial Activity No. 1: Liaison The Contractor shall: a) Obtain all necessary approvals and clearances for the study from the collaborating institutions and appropriate agencies within each community in which the investigation is planned. This includes any required local institutional review board clearance, Costa Rica Ministry of Health approvals, and any other scientific, administrative, or ethical approvals required. b) Assist in arranging communications or meetings as needed, including those between the NCI research investigators and the collaborating hospitals, screening centers, laboratories, and/or agencies for those parties whose cooperation or approval is necessary. c) Attend and report on such meetings, provide all background material required, and take action on recommendations in consultation with the COR. d) Provide for continued liaison between the NCI COR and scientific collaborators in Costa Rica and elsewhere as appropriate throughout the course of the study about study progress and problems. e) Conduct educational, information, and public health promotion campaigns in the local Costa Rican community to inform the population of the study and its progress, as needed to maintain good stature in the community. Activity No. 2: Preparation of Study Materials and Forms The Contractor shall: a) Develop forms for the study, as well as other materials to be used in the study. This shall include informational brochures, questionnaires, and other study forms. b)Translate materials from English to Spanish and/or from Spanish to English, as required. Activity No 3: Identification of Study Subjects The Contractor shall: a) Provide computerized data from census data of number of women potentially eligible for the study in the different areas. Activity No. 4: Storage and Handling of HPV Vaccines The Contractor shall: a) Obtain the required permissions to allow the import of the HPV vaccines required for this study. b) Coordinate the purchase, receipt, transfer and storage of vaccines in preparation for the study. Vaccine shall be maintained in a cold chain at all times. c) Provide adequate security, alarm, and back-up systems to assure that vaccines are maintained in a cold chain. Activity No 5: Recruitment of Study Participants The Contractor shall: a) The contractor shall obtain lists of Minimal sample units (UPM in Spanish), and be prepared to identify houses located in selected UPMs to identify potential eligible girls aged 11 to 20 in order to invite them to participate in the study. Activity No. 6: Data Preparation and Entry The Contractor shall: a) Expand and implement the network of computers and related hardware, as well as the data management system, needed for this study. b) Ensure appropriate day to day management of the local data and provide adequate disaster, back-up and recovery mechanisms to ensure that data are not lost. Activity No. 7: Select, recruit and train new staff to perform the activities of the One-dose Trial The Contractor shall: a) Hire the necessary staff for the one-dose trial. b) Train the newly-hired staff on the procedures of the one-dose trial. Activity No. 8: Select and Obtain basic equipment for the beginning of the new study The Contractor shall: a) Purchase necessary equipment for the one-dose trial. CAPABILITY STATEMENT/INFORMATION SOUGHT To be deemed capable of providing services that meet the requirements, please submit a written capability statement demonstrating the following: 1. Ability to interact with IRBs and Costa Rica Ministry of Health to obtain approvals for the work. 2. Ability to prepare study materials. 3. Laboratory capacity in order to handle and store biological samples and vaccine in cold chain. 4. Information-technology capacity in order to update existing data management system. 5. Clinical doctors to assess the need for care and either provide the necessary clinical management or refer to additional medical systems. We encourage all responsible sources, particularly small businesses, to submit detailed concise information which will be considered by the agency. This requirement is assigned a code of 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is 500 employees. SUBMISSION INFORMATION Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. For small businesses, statements should include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concerns name, point of contact, address and DUNS number. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Corwin Stephens, Contracting Officer, corwin.stephens@nih.gov in Adobe Portable Document Format (PDF), by February 16, 2016 4:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/HHS-NIH-NCI-SS-ETSB-1010-59/listing.html)
- Place of Performance
- Address: Costa Rica, United States
- Record
- SN04013171-W 20160210/160208234438-76892d87057cd0e60deff5c441646d22 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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