U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
American Recovery and Reinvestment Act (ARRA) – Section 317 Immunization Program: Strengthening the Evidence Base
Epidemiology and Laboratory Capacity for Infectious Diseases (ELC)
Evaluation of Meningococcal Conjugate Vaccine and other High-Priority Vaccine Preventable Diseases
Announcement Type: Revision – Type 3
Funding Opportunity Number: CDC-RFA-CI07-70403ARRA09
Catalog of Federal Domestic Assistance Number: 93.712
Key Dates:
Application Deadline: June 26, 2009
I. Funding Opportunity Description
Authority: Public Health Service Act Sections 301(a)[42 U.S.C. 241(a)] and 317(k)(2)[42 U.S.C. 247b(k)(2)], as amended and the American Recovery and Reinvestment Act (ARRA) of 2009 (Public Law 111-5).
Background: The American Recovery and Reinvestment Act of 2009 (ARRA) was signed into law on February 17, 2009. ARRA is designed to stimulate economic recovery in various ways including strengthening the Nation’s healthcare infrastructure and reducing healthcare costs. Towards economic recovery specifically, ARRA requires that expenditures and activities be initiated as quickly as possible consistent with prudent management and oversight so that funds are expeditiously deployed into the community. In meeting the programmatic requirements of this Announcement, recipients of ARRA funding must use the funds to maximize job creation, job retention, and overall economic benefit (ARRA Sec. 1602).
The Prevention and Wellness Fund section of ARRA provides funding to the Office of
the Secretary (OS) of the Department of Health and Human Services (HHS) to carry out activities in support and enhancement of CDC’s immunization program. This Funding Opportunity Announcement (FOA) describes opportunities for ARRA immunization funding which will be awarded on behalf of the OS through CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement. These funds should be utilized to support staff, located in either the communicable disease prevention and/or vaccine-preventable diseases section of applicant’s organization as most appropriate.
The burden of meningococcal disease in adolescents in the United States is substantial. Of the over 250 cases that occur annually among 11-18 year-olds, 10-15% are fatal and an additional 10-15% have long-term sequelae such as limb loss, hearing loss, or neurologic deficits. Quadrivalent meningococcal conjugate vaccine (MCV4-diphtheria) was licensed for use in the United States in 2005. This vaccine protects against four serogroups (A,C,Y,W) that cause approximately 75% of disease occurring in adolescents. The great majority of this disease burden is caused by serogroups C and Y, while A and W135 are exceedingly rare. ACIP recommends vaccination of all adolescents aged 11-18 years and other persons aged 2-55 years at increased risk for meningococcal disease.
There are limited data on the effectiveness of meningococcal conjugate vaccine or the duration of protection. Pre-licensure clinical trials were immunogenicity studies which compared the immune response among the vaccinated to those who received the only licensed vaccine for meningococcal disease at the time, meningococcal polysaccharide vaccine (MPSV4). Clinical effectiveness studies suggest MPSV4 is 85% effective against serogroup C disease; there are no effectiveness estimates for preventing serogroup Y disease.
Over 4 million adolescents are vaccinated annually against meningococcal disease. This vaccine is one of three vaccines recommended for adolescents at 11-18 years-old, preferably at the 11-12 year-old vaccination visit. There are little data in the United States about how adolescents respond to conjugate vaccines. Post licensure vaccine effectiveness investigations are important to assess vaccine performance under conditions of community use. For example, they may also provide insight into how adolescents respond to vaccines given outside of clinical trials. A case-control investigation of the effectiveness of meningococcal conjugate vaccine has been implemented since 2006 in the 10 Active Bacterial Core surveillance sites and an additional 10 sites participating in CDC’s MeningNet. However, enrollment to date has been insufficient to complete the investigation in a timely fashion. Supplemental funding to existing sites as well as adding additional sites is needed to ensure enrollment of a higher proportion of identified cases of meningococcal disease among adolescents in the U.S. In 2005, CDC determined that these activities were not research but rather represented evaluation of the performance of a public health program.
In addition to evaluating meningococcal vaccine effectiveness, other state vaccine preventable disease (VPD) monitoring and vaccine impact evaluation activities would benefit from time limited enhancements to address priority needs. In response to the current Hib vaccine shortage, enhanced surveillance for Haemophilus influenzae and serotyping of isolates is critical to determining the impact of the ongoing recommendation to defer the booster dose. Evaluating new pertussis and mumps diagnostics is a critical step in assessing the burden of disease and/or determining the effectiveness of newly recommended vaccines. Determining the effectiveness of the new 2-dose policy for varicella vaccine is also critical to evaluate vaccine policy and inform disease prevention and control policies.
Purpose:
The purpose of the ELC cooperative agreement program is to assist state public health agencies improve surveillance for, and response to, infectious diseases by (1) strengthening epidemiologic capacity; (2) enhancing laboratory practice; (3) improving information systems; and (4) developing and implementing prevention and control strategies. The focus of the activities is on naturally occurring infectious diseases and drug-resistant infections. ELC aims to enhance the ability of public health agencies to identify and monitor the occurrence of known infectious disease of public health importance; detect new and emerging infectious disease threats, identify and respond to disease outbreaks; and use public health data for priority setting, policy development, and for prevention and control.
The purpose of this ARRA-317 project is to evaluate the effectiveness of meningococcal conjugate vaccine and other high priority vaccine-preventable diseases. In order to inform policy regarding meningococcal vaccination in the United States in the next 5 years, this project will support ELC sites to identify all cases of meningococcal disease, especially among the vaccinated cohort (persons aged ≥11 years and born on or after January 1, 1986, currently aged 11-23 years). This project will also support improved diagnostic capabilities to serogroup all isolates of N. meningitidis at state public health laboratories with support of the CDC laboratory. Building capacity for improving meningococcal disease laboratory and epidemiologic surveillance may allow states to improve surveillance for other vaccine-preventable diseases.
Specific objectives
1. To enhance laboratory and epidemiologic surveillance for meningococcal disease and other vaccine-preventable diseases.
2. To evaluate the effectiveness of a single dose of Meningococcal conjugate vaccine against meningococcal disease caused by serogroups C and Y in adolescents aged ≥11 years and born on or after January 1, 1986, currently aged 11-23 years , using a case-control approach.
3. To coordinate improvements in Haemophilus influenzae serotype b disease case ascertainment and investigation in response to the vaccine shortage.
4. To recognize and communicate to CDC opportunities to evaluate pertussis diagnostics in outbreak settings and/or determine pertussis vaccine effectiveness, and/or mumps and varicella outbreaks as opportunities to evaluate diagnostic tests and vaccine effectiveness.
This program addresses the “Healthy People 2010” focus area of Immunization and Infectious Diseases. Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Preparedness, Detection and Control of Infectious Diseases and the National Center for Immunization and Respiratory Diseases: Protect Americans from Infectious Disease.
This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm. In 2005, CDC determined that these activities were not research but rather represented evaluation of a program.
Activities
Applicants must address all components of Activity 1 (Evaluation of Meningococcal Vaccine). For Activity 2 (Evaluation of High-Priority Vaccine Preventable Diseases), applicants must address at least one of the components a) through d), All applicants must address Activity 3 (Track, Measure, Report).
Activity 1: Evaluation of Meningococcal Conjugate Vaccine
a) Identify and serogroup all cases of meningococcal disease (defined by isolation from a normally sterile site or detection of meningococcal DNA on polymerase chain reaction) in the entire state or proposed catchment area in which enrollment will occur.
b) Transfer all isolates and specimens to CDC for confirmation of serogroup.
c) Implement a protocol for enrolling cases and controls in a case-control investigation of vaccine effectiveness. This includes participating in conference calls and training sessions, collecting data including consenting participants, and transmitting data to CDC. (see Appendix A for protocol “Evaluation of Tetravalent Meningococcal Conjugate Vaccine Effectiveness”)
d) Complete case investigations to determine demographic information, clinical presentation and outcome, vaccination status, type of vaccine, and date of vaccine for all cases of meningococcal disease, and vaccination status, type of vaccine, and date of vaccination for controls enrolled in the investigation (see Appendix A for more details).
Activity 2: Evaluation of High-Priority Vaccine Preventable Diseases.
Conduct at least one of the following activities a) through d), in accordance with guidance from the Manual for Surveillance of Vaccine Preventable Diseases (http://www.cdc.gov/vaccines/stats-surv/worksheets.htm#chapters).
a) Strengthen case finding and investigation of Haemophilus influenzae in children < 5 years including improved serotyping of isolates.
b) Identification and notification to CDC of outbreaks of pertussis or prolonged cough illness as opportunities to evaluate vaccine effectiveness and performance of diagnostic testing in the outbreak setting.
c) Identification of potential mumps cases and collection of specimens from patients with suspected mumps in order to confirm the diagnosis or to test for non-mumps causes of parotitis. If mumps outbreaks occur, collaborate on investigations of vaccine effectiveness.
d) Identify varicella outbreaks in populations with moderate 2-dose vaccine coverage to provide opportunities for evaluation of the effectiveness of two doses of varicella vaccine
Activity 3: Track, measure, and report programmatic and fiscal activity and economic impact as required by this Announcement, ARRA, and the U.S. Office of Management and Budget (OMB). See Section I – Purpose, above for key program goals and objectives and Section VI.3., below for details on reporting requirements. CDC has identified the following specific performance measures for meeting the program goals and objectives and the specific recipient activities above. These may be reviewed and modified after award to assure they are appropriate for the approved/funded activities. Work with CDC to review, track, and monitor progress towards the measures and to address any risks, delays, performance problems, etc.
Performance Measures:
For Activity 1 (Evaluation of Meningococcal Conjugate Vaccine):
- Number of cases of meningococcal disease identified
- Number (%) of cases enrolled
- Number (%) of controls enrolled
- Number of complete case/control sets enrolled.
For Activity 2 (Evaluation of High Priority Vaccine Preventable Diseases)
- Number (%) of H. influenzae cases serotyped
- Numbers of outbreaks of pertussis, mumps, and varicella identified and notified to CDC for investigation of laboratory tests and vaccine effectiveness.
In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.
CDC activities for Activity 1 are as follows:
1. Manage and analyze the data in the manner specified by the evaluation protocol for each case and control.
2. Conduct teleconferences to update site personnel and review any changes to the protocol or issues.
3. Perform serogrouping of all meningococcal isolates.
4. Provide regular progress updates to the participating sites.
CDC activities for Activity 2 are as follows:
1. Provide guidance on enhanced surveillance and investigation of outbreaks of other vaccine preventable diseases as specified in this document.
2. Provide assistance with diagnostic testing, where appropriate, for varicella, mumps or non-mumps causes of parotitis.
3. Provide confirmatory testing for mumps or varicella on select cases for the purpose of quality control and provide testing for non-mumps causes of parotitis for which diagnostics are not available in the awardee’s laboratory.
CDC activities for Activity 3 are as follows:
1. Lead the development of specific milestones and performance measures.
2. Provide CDC, HHS, and OMB-developed reporting tools, templates, procedures, etc., for programmatic, fiscal, and economic impact tracking and reporting, including for recipient’s monthly reporting to CDC and quarterly reporting per ARRA Section 1512 (see Section VI.3. – Reporting Requirements, below).
3. Closely monitor recipient’s monthly and quarterly reports and provide specialized assistance as necessary to help recipient address any specific risks, delays, or performance problems.
II. Award Information
Type of Award: Cooperative Agreement. CDC’s involvement in this program is listed in the Activities Section above.
Award Mechanism: U01
Fiscal Year Funds: ARRA funding is two-year funding (FY2009-2010).
Approximate Current Fiscal Year Funding: $ 3,560,350,
Approximate Total Project Period Funding: $ 3,560,350 (This amount is an estimate, and is subject to availability of funds.) This includes direct and indirect costs.
Approximate Number of Awards: 32
Approximate Average Award: $ 111,260
Floor of Individual Award Range: $50,000
Ceiling of Individual Award Range: $150,000
Anticipated Award Date: August 30, 2009
Budget Period Length: Awards will be made as supplements for a 24-month project within awardee’s current ELC budget period which ends December 31, 2011.
Project Period Length: ELC project period expires December 31, 2011.
This ARRA funding should be considered one-time funding. An award of ARRA funds under this announcement does not constitute a commitment by the U.S. Government to continue funding beyond the funding period of this announcement.
III. Eligibility Information
III.1. Eligible Applicants
Eligibility for these supplemental awards is limited to current grantees under the ELC grant program. The 58 current ELC grantees are funded under the following ELC Funding Opportunity Numbers:
CI04-040:
Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Houston TX, Iowa, Illinois, Indiana, Kansas, Kentucky, Los Angeles County CA, Louisiana, Maine, Massachusetts, Michigan, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, New York, New York City NY, North Carolina, Ohio, Oklahoma, Pennsylvania, Philadelphia PA, Republic of Palau, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
CI07-701: