Feature Articles
Opportunities and Resources
- Collaborate With Brazilian Researchers, Request Supplemental Funds
- Staged Vaccine Development Takes Center Stage in New BAA
- Round 14 of Grand Challenges Explorations Now Open
In The News
Advice Corner
New Funding Opportunities
Use EQAPOL to Ensure Reproducible Research Results
To help you ensure that your scientific findings are high quality and reproducible, labs performing vaccine trials or HIV/AIDS research should check out the External Quality Assurance Program Oversight Laboratory (EQAPOL).
EQAPOL is an NIAID-funded resource managed by the Immunology Virology Quality Assessment Center, part of the Duke Human Vaccine Institute.
Proficiency Testing
EQAPOL offers proficiency testing (PT) programs for the following assays:
- ELISpot (Enzyme-linked immunosorbent spot)—measures the number of cells producing interferon gamma (IFN-γ) in response to peptide stimulation.
- Flow Cytometry—measures cytokines produced by CD4+ and CD8+ T cells following peptide stimulation, specifically the following four analytes: IFN-γ, Tumor necrosis factor alpha (TNF-α), interleukin 2 (IL-2) and CD107α.
- Luminex—measures five analytes in serum samples: IFN-γ, IL-2, IL-6, TNF-α, and IL-10.
- A3R5 neutralization—measures HIV neutralizing antibody responses using the A3R5 cellline.
Within each PT program, laboratories participate in two external proficiencies (EPs) annually. For each EP, EQAPOL sends highly characterized test specimens (e.g., cryopreserved peripheral blood mononuclear cells (PBMCs) or cytokine-spiked serum) and assay reagents. At the conclusion of each EP, labs receive a detailed report that includes a score and performance rating.
EQAPOL offers sites assistance to improve their performance. As part of such assistance, sites will teleconference with the EQAPOL group to discuss their assay performance, including potential problems and strategies for improvement. Note that EQAPOL is an educational, not punitive, program.
The program serves more than 50 laboratories worldwide. EQAPOL will add additional sites with NIAID's approval.
Virus Panels and PBMCs
EQAPOL establishes and characterizes unique clade-specific HIV virus panels and maintains a PBMC bank and reagent repository.
These activities support EQAPOL’s Viral Diversity Program, which is building a set of fully characterized viruses from early acute HIV infections that are consistent with the degree of viral evolution present globally. Currently, the viral diversity panel includes over 175 viral specimens representing 6 subtypes (A, B, C, D, F, G), 2 sub-subtypes (F1, F2), 8 CRFs (01, 02, 04, 14, 22, 24, 47, 59), 29 unique recombinant forms (URFs), and 3 group O viruses from 27 countries.
The panel is available to NIAID-approved laboratories free of charge, although sites must cover shipping costs.
EQAPOL has also developed a repository of highly characterized cryopreserved PBMCs, taken from over 150 donors, including both HIV seronegative and seropositive donors. Characterization includes Class I HLA 4-digit typing, immunphenotype subset analysis, serology results for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and Hepatitis B titers, and HIV-1 status.
NIH-funded laboratories have access to samples from the repository with NIAID's approval.
How to Get Started
To participate in EQAPOL’s PT programs, email EQAPOL and indicate which programs interest you, as well as a description of your laboratory and how your work supports the NIAID mission. Labs don’t need NIAID funding to participate. EQAPOL will contact you to complete enrollment after NIAID approves your site.
For access to EQAPOL’s viral specimens and PBMCs, email EQAPOL and specify which sample types your laboratory would like to receive. Explain how you intend to use the samples. EQAPOL will contact you to complete enrollment after NIAID approves your site.
Collaborate With Brazilian Researchers, Request Supplemental Funds
Thanks to a recent funding opportunity announcement (FOA), you have a chance to request supplemental funding by working with scientists from Brazil.
Through the Administrative Supplements for U.S.-Brazil Biomedical Collaborative Research, NIAID intends to foster, stimulate, and expand collaborative basic, translational, and applied research between eligible NIH awardees and Brazilian researchers.
Speaking of eligibility, take note:
- Your parent award must be active, but it cannot be:
- In the last year of a competitive segment.
- Under a no-cost extension.
- The research you propose in the supplement application must be within the original scope of that award and in the areas of infection-associated cancers, allergy, immunology, and infectious diseases, including HIV/AIDS and its comorbidities. Learn more about research areas of interest in the FOA.
General Requirements
You and your collaborating Brazilian investigators should work together to prepare and submit applications in response to this FOA and a corresponding announcement by the Brazilian Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq).
Both applications must use the same title and contain the same scientific content and budget— written in English—that specifies the funding needs of each collaborating scientist or institution.
To the greatest degree possible, the U.S. and Brazilian applications should be fully harmonized or consist of the same text.
You must agree to provide a complete English copy of your supplement request to your Brazilian counterparts. If you don't, NIH will not consider your request.
Be sure to take into account any confidentiality or proprietary concerns before deciding what information to submit in your supplement request.
Additional Information
If you have questions, touch base with the appropriate program officer listed in the FOA's Section VII. Agency Contacts.
For full details, read the August 28, 2014, Guide notice. The application due date is October 27, 2014. Note that this date was changed from October 23 as announced in this September 19, 2014, Guide notice.
Staged Vaccine Development Takes Center Stage in New BAA
Through a recent broad agency announcement (BAA), NIAID's Division of AIDS seeks proposals from offerors who can support multifunctional teams in advancing the development and manufacture of HIV vaccine candidates; specifically, those that have demonstrated manufacturing feasibility* and success in nonhuman primate (NHP) challenge studies, equivalent preclinical animal models, or early human clinical trials.
*Vaccine has been manufactured in a small scale and the process is scalable under Good Manufacturing Practices.
This BAA will support activities that further develop the current leading HIV vaccine platforms. The platforms listed below are the primary areas of interest, but offerors are not limited to them in their proposals.
- Recombinant HIV protein
- POX virus vectors
- DNA vaccines
- Replication defective adenovirus vectors
- Replication competent viral vectors
- Adeno-associated virus (AAV) vectors
NIAID will evaluate proposals based on their potential to advance the vaccine platforms through a three-staged approach:
- Stage I—refining and implementing the product development plan and initiating limited activities to prepare for the Current Good Manufacturing Practice production of the vaccine candidate.
- Stage II—manufacturing, formulating, and releasing the product for Phase I, II, and III clinical trials.
- Stage III—continuing the ongoing stability program, pre-licensure activities, product characterization studies, and updated regulatory submissions that would allow the product to remain in regulatory compliance and acceptable for future clinical trials.
Offerors must submit their proposals in two ways:
- Disc (CD or DVD)
- Online through NIAID's electronic Contract Proposal Submission (eCPS) Web site
Note: the content of disc and online proposals must be identical. Submitting proposals by fax or email is not acceptable.
For more information on submitting your proposal, including creating and naming files, see the solicitation's Attachment 1: Packaging and Delivery of the Proposal.
Find full details in the September 12, 2014, FedBizOpps.gov solicitation. Proposals are due by December 1, 2014.
Round 14 of Grand Challenges Explorations Now Open
Researchers working on NIAID-related topics should check out several new Grand Challenges Explorations grants from theBill and Melinda Gates Foundation.
Phase I grants provide up to $100,000 in direct costs over an 18-month project term. Awardees may then apply for a Phase II award of up to $1 million in total costs over a grant term of two years or less. The foundation anticipates funding around 80 awards.
You can submit two-page proposals until November 12, 2014, on the following topics:
- Surveillance Tools, Diagnostics, and an Artificial Diet to Support New Approaches to Vector Control
- New Approaches for Addressing Outdoor/Residual Malaria Transmission
- New Ways to Reduce Pneumonia Fatalities Through Timely, Effective Treatment of Children
- New Ways of Working Together: Integrating Community-Based Interventions
Find application instructions and additional topics at Grand Challenges Explorations Round 14.
Verify That Your FY 2014 Award Information Is Correct
Be aware that NIH is finalizing reporting files found on RePORT for FY 2014, which as you likely know, ended yesterday. NIH will "freeze" these data records on Friday, so before then verify that any information concerning your grants is accurate and complete.
What to Do
To begin, go to NIH Awards by Location and Organization, select FY 2014, search for your organization, and review the information listed.
If you find an error, contact your authorized organizational representative (AOR) or signing official (SO). He or she will need to email the eRA Commons Help Desk by 5:00 p.m. EST on October 3. Only AORs and SOs have the authority to request changes to reporting files. They should read the September 26, 2014, Guide notice for details on how to report such errors and make corrections.
Contact Commons@od.nih.gov with questions.
News Briefs
Comment on Sex as a Biological Variable. NIH wants your feedback as it develops policies requiring applicants to consider sex as a biological variable for research involving animals and cells. Learn more in the September 11, 2014, Guide notice. Respond through October 13, 2014.
Fill Us In on Viral Disease Studies. NIAID issued a request for information (RFI) about natural history studies that evaluate the clinical course of viral disease in a target patient population, including information about design strategies for clinical trials and the use of alternative and innovative research methods. See the September 17, 2014, FedBizOpps.gov RFI for the full description. Act quickly—responses are due next Wednesday, October 8.
Next Chance to Apply for SRATP R01 Approaches. The next application deadline for the Sustained Release of Antivirals for Treatment or Prevention of HIV (SRATP) R01 is January 7, 2015. See our October 23, 2013, article "An R01 Funding Opportunity for HIV Researchers" for more information.
Make Sure That New Application Is New
When you use an old application as the starting point for a new (A0) application, the A0 must not reference any prior applications or reviews—if it does, NIH will withdraw it without a review.
NIH clarifies this point and some others in its updated Frequently Asked Questions on Resubmissions of NIH Applications, published on September 18, 2014. The updates are marked with yellow "new" icons. For NIH's explanation of when an application would be withdrawn from review, see Question B8.
Although the earlier version of these FAQs already emphasized that an A0 shouldn’t reference a prior application in any way, the updated FAQs add a series of examples so you'll know how to properly reference earlier research without making your A0 application sound like a resubmission (A1).
Here are some tips based on their examples. (These should look familiar if you read our April 17, 2014, article “Big News on Application Submission Policy.")
- Present your work from the prior funding period as preliminary data or as a rationale for your newly proposed research. Don't include a Progress Report section or Progress Report Publication List.
- Revise and improve your application based on lessons learned from the previous review, but don't mention the review in any way.
- Your application must not have an introduction to address reviewer comments or describe how it was changed.
- Don't highlight or otherwise mark text that changed from the previous application.
- Other parts of the application shouldn't address or mention the previous review, either.
- Remind your collaborators that letters of support should not refer to previous submissions or reviews. For applications requiring reference letters, remind your referees that these letters should not include any references to a previous application or review.
The FAQ updates also emphasize that your A0 should use the receipt date for new applications, not the one for resubmission, renewal, or revision applications. Other questions explain when and whether you should withdraw an application.
Speaking of the April submission policy, we anticipate that application numbers will rise as a result. In our next issue, we will discuss the possible effect on success rates. For now, know that if your A0 does not contain significant improvements from your A1, a different outcome is not likely.
Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
"I am in the final two years of my K23 award and was recently awarded an R21 grant. Do I need to communicate any new information to NIAID?"—Sung Choi, University of Michigan
No, NIAID does not need any additional information unless you are reducing your level of effort on the Mentored Patient-Oriented Research Career Development Award (K23). That said, as a courtesy, you should inform the grants management specialist and program officer assigned to your career development award about your new research grant.
"My PI's R01 funds my current research project. Can I apply for an F32 award using the R01-funded project?"—anonymous reader
No, you cannot use the R01-funded project for an NRSA Individual Postdoctoral Fellowship (F32) application since NIH cannot support an already-funded project or pay for research that has already been done. You can, however, use preliminary data that you generated from the R01-funded project to support your independent research project proposal in the F32 application.
When you're ready to apply for the F32, read the funding opportunity announcement carefully and follow all instructions.
You may find our online resources helpful. Go to our Fellowship Grants (F) portal to get started.
See announcements at NIAID Funding Opportunities List.