STATEMENT OF WORK RFQ 2009-Q-11285.pdf

STATEMENT OF WORK

SOLICITATION NUMBER : 2009-Q-11285

Title of Project: Effectiveness of Rotavirus Vaccine in Preventing Rotavirus Gastroenteritis

C.1 Background and Need

Rotavirus gastroenteritis is the most common cause of severe diarrhea in US children <5 years of age, accounting for more than 30% of all severe childhood gastroenteritis episodes requiring medical attention. In 2006, a pentavalent rotavirus vaccine was licensed and recommended for use in the United States and in 2008, a monovalent rotavirus vaccine was licensed and recommended. In an evaluation of the rotavirus vaccine program during the 2008 season, the pentavalent rotavirus vaccine was found to be 85%-89% effective against rotavirus acute gastroenteritis requiring an emergency department visit or inpatient admission during the first rotavirus season post-vaccination. With the introduction of the monovalent vaccine, it is important to determine the effectiveness of monovalent and pentavalent rotavirus vaccines when used simultaneously in the community and in combination for individual patients. Additionally, as vaccinated children become older, it is necessary to document the duration of protection conferred by vaccination during subsequent seasons. Furthermore, given the wide variety of heterotypic rotavirus genotypes not included in present day vaccines and the constant evolution of new strains, it is important to monitor protection against all rotavirus strains and determine if changes occur in circulating strains as a result of vaccine selection pressure in the post-vaccination era.

C.2 Project Objective

1. Assess the duration of pentavalent rotavirus vaccine protection among children 1 – <3 years of age.

2. Determine the vaccine effectiveness of mixed receipt of monovalent and pentavalent rotavirus vaccine among children 15 days – <12 months of age.

3. Evaluate vaccine effectiveness against the most commonly detected strain during the

2009 season.

C.3 Scope of Work

The contractor shall provide all labor, equipment, supplies, and facilities necessary to 1) conduct active surveillance in the emergency department and inpatient wards to identify children age <3 years of age presenting with acute gastroenteritis, 2) collect immunization information from all enrolled children, and 3) enroll control patients <3 years of age presenting with acute respiratory illness.

The Period of performance will not exceed 12 consecutive months following the award of a U.S.

Government Purchase Order / Contract.

C.4 Technical Requirements

The Contractor shall conduct the following tasks:

1) Conduct active surveillance for acute gastroenteritis: Children ages 15 days – <3 years with diarrhea (≥3 loose stools in a 24 hour period) who present for treatment shall be enrolled in the active surveillance program. Information about the history of the illness and a stool specimen should be collected from each enrolled patient. Serum or plasma shall be collected from patients who have blood drawn as part of their clinical care.

2) Test collected stool specimens: Stool specimens shall be tested for rotavirus using an enzyme immunoassay (EIA).

3) Enroll control patients with acute respiratory infections: Children ages 15 days – <3 years with acute respiratory infection (ARI) symptoms who present for treatment shall be enrolled as control-patients.

4) Collect rotavirus immunization history on all enrolled cases and controls: Immunization records shall be obtained from the parent/guardian of participants, if available at the time of enrollment. ImmTrac, the statewide immunization registry, shall also be searched for immunization records and the patient’s most recent immunization providers shall be contacted for immunization records

C.5 Reporting Schedule

All work shall begin within 7 calendar days after date of award of the order and shall be completed within 1 year after date of award.

The vendor shall provide a monthly progress report along with his invoice showing the number of cases and controls enrolled during the month, the number of stool and serum specimens collected, and the number of stool and serum specimens collected that tested positive for rotavirus.

C.6 Special Considerations

Confidentiality of Data: Data will be kept on password-protected computers behind security firewalls. All printed data and electronic data will be kept in locked offices. Only the PI and the

PI's staff will have access to the data. The potential risk of a loss of confidentiality will be minimized by the use of study identification numbers, which can only be linked to the patient by the study investigators.

Human Subjects Review: The vendor shall obtain approval to conduct the study from their

Institutional Review Board prior to beginning data collection.

Identification and Disposition of Data: Databases containing clinical histories of diarrhea patients, rotavirus test results, and immunization records from all cases and controls along with a brief report with information deemed to be relevant for data analysis and interpretation shall been delivered to the project officer at CDC. Data shall be submitted in Access, Excel, or other similar flat file format. Additionally, aliquots of serum, plasma, and stool specimens shall be sent to the viral gastroenteritis laboratory at CDC. The key linking study identification numbers with individual patients shall be maintained by the vendor and shall be destroyed when instructed to do so by CDC.

Review of Data: Data generated as part of this contract will be reviewed by staff epidemiologists in the Division of Viral Diseases prior to publication or dissemination to the general public.

C.7 Government Furnished Property

The vendor shall provide all equipment required to perform the services.

C.8 References - NONE

C.9 Deliverables

All data collected including clinical histories of diarrhea patients, rotavirus test results, and immunization records from all cases and controls along with a brief report with information deemed to be relevant for data analysis and interpretation shall be delivered to the project officer at CDC by contract end date. Additionally, aliquots of serum, plasma, and stool specimens shall be sent to the viral gastroenteritis laboratory at CDC. Data shall be submitted in Access, Excel, or other similar flat file format. All laboratory specimens shall be sent to:

Rotavirus Laboratory, Attention: Jon Gentsch

C/o Tara Kerin

Division of Viral Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd., NE

DASH Unit 75

Mailstop G-04

Atlanta, Georgia 30333

Item

Description

Quantity

Delivery Date

1 Progress report showing active surveillance, control enrollment, and collection of immunization records

1 to Project Officer Monthly following the end of the month

2 Synthesis of surveillance data, test results, and immunization records into database

1 to Project Officer By contract end date

3 Aliquots of serum, plasma, and stool specimens

1 Aliquot from all available specimens to

CDC Viral

Gastroenteritis

Laboratory

By contract end date

C.10 Project Officer

Jacqueline Tate, PhD

Epidemiologist

Epidemiology Branch/Division of Viral Diseases

National Center for Immunizations and Respiratory Diseases

1600 Clifton Road, NE, MS-A47

Atlanta, Georgia 30333

Tel: 404.639.4559

Fax: 404.639.8665

E: jqt8@cdc.gov

C.12 Minimum Vendor Qualifications

The vendor must have a large patient population (at least 750 cases of acute gastroenteritis among children <2 years of age seen in the emergency department per year for the past 2 years) that will ensure collection of adequate numbers of specimens (at least 70 rotavirus positive stool specimens) to calculate vaccine effectiveness during a dampened rotavirus season. In a rotavirus vaccine effectiveness evaluation performed, 90 rotavirus positive cases were indentified which enabled vaccine effectiveness to be estimated.

The vendor must have knowledge of vaccine coverage rates to assess vaccine impact and access to an immunization registry to obtain immunization status of enrolled participants as well as established relationships and protocols with area physicians to collect immunization data on patients not included in the registry.

The vendor must have established protocols for data collection that will enable rapid and efficient collection of data during an abbreviated rotavirus season.