The University of Arizona

Immunology 419H/519

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Vaccine Proposal DRAFT

Request for Proposal
Proposal Preparation
Pink Sheets
Peer Evaluations

Cooperative learning using formal teams is an integral tool in VSC 519/MIC 419H. Teams will be formed during the first class meeting based on your self-designated expertise. Your team will then meet periodically in class to work on the formal team report in the form of a vaccine proposal. The course instructor will be present as a facilitator; however, the team decides how to meet the goals of the project.

The Team Project has been designed to

Your team will write a vaccine proposal for a pathogen or tumor to which there is not currently an effective vaccine. There must be an animal model if the vaccine is for humans, as your tests for protective immunity must be done in animals. The project has been divided into several sections as noted in the calendar. Each team will submit one proposal based on the project assignment. The final report is expected to meet all requirements and to appear seamless, i.e., no obvious format or style differences between sections done by different team members.

Your textbook has information about basic vaccine design: Janeway et al. Immunobiology in Chapter 14. The Pechenik text A Short Guide to Writing About Biology is an excellent resource for formal scientific writing. The Toolbox Reading and Writing About Immunology also has some suggestions about sources, as well as a list of commonly misspelled or misused words. Two sample proposals, one from 419 2004 and one from 519 2004 are available; note that the requirements have changed somewhat since these were written.

Request For Vaccine Proposal

The JMD Foundation, a nonprofit foundation dedicated to the improvement of human and animal welfare and supported by (nonexistent) voluntary contributions from like-minded citizens, solicits a proposal for a vaccine Phase 2 trial (http://www.niaid.nih.gov/clintrials/clinictrial.htm or http://clinicaltrials.gov).

The goal of the proposal is for you to apply your knowledge of basic immunology to a real-world immunology problem. The best minds in immunology have not yet solved this problem, so it is difficult, with no "RIGHT" answer! Your ability to research what is known about your pathogen, your immunology knowledge, and your reasoning are what will be evaluated. This proposal must be submitted by a team, with all team members receiving the same grade. Write this proposal for your peers (other students in MIC 419), since it will be peer-reviewed at a study section in mid April.

FORMAT and CONTENT:

Cover sheet for paper copy: Type double-spaced and align left [Please do NOT use a cover or folder]

Other sections of the report should be headed with the proposal title. Divide the proposal into the sections listed below. Pages should be numbered at the bottom. Proposals must be single-spaced and 12 point type. Note page limits for some sections.

Literature Review: Summarize what is known about your pathogen and protective immune responses to it. Include relevant information about pathogen structure, disease mechanism, epidemiology, population at risk, and previous or current treatments or vaccines. This section should explain why you chose this pathogen as the subject for your proposal and what subject population you are targeting. To find review articles and research papers, use the Medline/Pub Med links at the Arizona Health Sciences Library site http://www.ahsl.arizona.edu . Every paragraph must have at least one source; all sources must be primary research articles or scientific reviews. Do not cite sources for textbook information. PAGE MAXIMUM: five pages.

Description Of Vaccine: Include in your description the type of vaccine you will develop, the antigen(s) (particular epitopes, if applicable) to which you will induce immunity, any required adjuvants, and the type of immunity you plan to elicit to each antigen (note that ALL vaccines must activate both B cell and T cell responses). In addition, explain why you chose this type of vaccine and antigen. Discuss the problems you may encounter, and how you hope to avoid or minimize the disadvantages and maximize the effectiveness and safety of your vaccine. Having a difficult problem (for example, antigenic variation) will count in your favor at this point if you address the problem and make a reasonable attempt to solve it. PAGE MAXIMUM: five pages.

Description of Immunity Assessment: Describe the route and timing of administration and your choice and timing of immunological tests to demonstrate vaccine efficacy. You must include at least one test to measure specific antibody. Consider whether the antibody isotype is important and whether the biological functions of the antibody (such as neutralization) are crucial to its ability to be protective, and make sure your tests reflect these issues. You must also include at least one test to measure T cell memory. You may measure specific effector functions such as cytotoxicity or cytokine synthesis; remember that you must demonstrate the antigen specificity of the response (an increase in total CD4+ T cells is unlikely to be measurable). Explain your rationale for the choices you have made here, describe how you will handle possible problems, and state what your criteria will be for a successful trial and how long the study will last. Initial vaccine regimens are always a "best guess" scenario, so use as your guide what you have learned about the kinetics of immune responses. PAGE MAXIMUM: five pages.

Lay Summary: Summarize in lay terminology the purpose of your vaccine, how it will be administered, possible side effects, and benefits to society if it is successful. PAGE MAXIMUM: one/half page.

Information Sources: Cite all sources in the body of the paper where information is used as (Authors, year). Give full citations for all sources at the end of the proposal, listing the sources alphabetically by last name of first author, and using the format Authors, Title, Journal, Volume:pages, year. Proposal must have a minimum of 10 sources, including at least 5 primary research articles.

Response to Pink Sheet: Your proposal will be peer reviewed by another team, who will submit written critiques. In the final draft of your proposal you must address these critiques by bolding changes made in the body of the proposal in response to the review and/or by adding a statement disagreeing with the review and explaining your reasons.

EVALUATION CRITERIA

Content:

Mechanics:

Proposal Preparation and Admit Tickets

The calendar contains intermediate due dates to help you keep on track for finishing the proposal by the due date. On some of these dates, individual Admit Tickets are due in class as a paper copy and electronically to Turnitin.com. Organized discussion activities on some dates will introduce you to group functioning and to immunological tests you will need for your proposal. You will also be encouraged to reflect on how well your team is functioning and to give feedback to your teammates about their contributions.

Pink sheets: Vaccine critiques

One you have written a vaccine proposal, you should know enough about the process to evaluate a proposal written by your peers. The team vaccine proposals written for this class will be made available on-line, and your team will be assigned to review and evaluate one. Your anonymous critique (see Pachenik for an explanation of how to write a critique) will be returned to the authoring team, and will be addressed by the authoring team in their final proposal. The evaluation will not affect the grade of the team writing the proposal but is worth 50 points to your final grade. On the due date you will submit two hard copies of your pink sheet, one with your name that will be graded and one without your name that will go to the authoring team. Be professional and use the above criteria to in evaluating the proposal; make constructive suggestions for improvements and note what is done well.

The evaluation (called a Pink Sheet because evaluations of proposals submitted to the NIH were formerly done on pink paper) should be about 1-2 single-spaced printed page(s). It should include one-two paragraphs summarizing the proposal you read (be sure to include the title) and a few paragraphs discussing how well you think the authors did presenting and explaining their proposal. Give specific examples of what you thought was well done or not well done, and make specific suggestions for improvements (if any). Do not criticize for format (i.e. not italicizing scientific names), since that may have been changed in translating the paper for web posting.

Peer Evaluations

All team members will evaluate themselves and their teammates for participation in the vaccine proposal; this evaluation is worth 50 total points (25 at midterm and 25 at semester's end). Intermediate evaluations will allow for midcourse corrections. Team members not completing the evaluation forms will receive a participation score of 0.

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Request for Proposal

The JMD Foundation, a nonprofit foundation dedicated to the improvement of human and animal welfare and supported by (nonexistent) voluntary contributions from like-minded citizens, solicits a proposal for immunology research.

The goal of the proposal is for you to apply your knowledge of basic immunology to a real-world immunology problem. The best minds in immunology have not yet solved this problem, so it is difficult, with no "RIGHT" answer! Your ability to research what is known about the problem, your immunology knowledge, and your reasoning are what will be evaluated. Write this proposal for your peers (other students in MIC 419H/VSC 519).

Due date for proposal: December 16 4PM in VSC 235.

Interim due dates (beginning of class period):

Format and Content

Cover sheet: Type double-spaced and align left

Other sections of the report should be headed with the proposal title (no names) and section title. Pages should be numbered at the bottom. Proposals must be single-spaced and no smaller than the font in Janeway et al. Note page limits for some sections.

Research Proposal

Literature Review: Summarize what is known about your problem: it may be basic or clinical immunology. This section should explain why you chose this problem as the subject for your proposal. For each piece of information in the review, cite the source in the body of the review as (Authors, Year); list the full citations in alphabetical ordeer by last name of first author in the Information Sources section. PAGE LIMIT: ten pages, not including Information Sources.

Specific Aims: In one-two sentences (each), summarize at least two research hypotheses.

Experimental Approach: Describe at least two experiments you will perform to prove or disprove your hypotheses, including all reagents, animals, and techniques. Explain your rationale for the choices you have made here, describe how you will handle possible problems, and state what your criteria will be for interpreting your data. PAGE LIMIT: ten pages.

Information Sources: Cite all sources in the body of the paper where information is used as (authors, year). Give full citations for all sources at the end of the proposal in alphabetical order as Authors (all), Year, Title, Journal, Volume: Pages.

Evaluation criteria

The criteria below are written to indicate what I expect in your final proposals.

Content

Title provides information for the reader about the subject of the proposal. Title has a maximum of 75 characters and uses clear language.

Literature Review is appropriate and clearly organized with subheadings and fully referenced. This section convinces the reader that the investigator knows enough about the problem and previous work to develop specific aims. Basic immunology knowledge is accurate, clearly explained, and applied appropriately.

Specific Aims are clearly stated as hypotheses.

Experimental Approach will contain full descriptions of appropriate experimental systems and statements describing how data will be interpreted. The investigator anticipates problems and proposes reasonable solutions.

Sources include a minimum of 15 primary references (research papers in peer-reviewed journals) published within the past 5 years. Additional print sources (review articles and books) are encouraged, but electronic sources are not allowed. Citations follow the format described above.

Mechanics:

Investigator has followed all directions and adhered to page limits and due dates.

Organization, including subheadings, paragraphing, and flow of information, contributes to the reader's understanding of major points and details.

Technical language is appropriate for students completing their first immunology course.

Correct grammar and spelling contribute to the clarity of proposal.

Cover page is signed by a peer proofreader.

 

Alternative format: Vaccine proposal

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http://microvet.arizona.edu/Courses/VSC519/vsc519proposal.html
Written by Janet M. Decker, PhD      jdecker@u.arizona.edu
Last modified August 22, 2006