Funding News Edition: November 16, 2022 See more articles in this edition
NIAID’s Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) prioritizes safe and effective HIV/AIDS vaccine development and invites research applications to translate advanced HIV-1 vaccine candidates from preclinical studies through process and product development, up to regulatory filing. Apply through the funding opportunity announcement (FOA) Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19, Clinical Trial Not Allowed).
The FOA’s overarching goals are to advance promising and innovative HIV vaccine platforms that elicit broadly neutralizing antibodies alone or in combination with other vaccine platforms or prevention modalities for evaluation in early clinical trials and to leverage the experience gained through the development and manufacture of various COVID-19 vaccines.
Objectives and Scope
The IPCAVD Program will fund a multidisciplinary consortium with expertise in vaccinology, animal models, molecular biology, cell biology, immunology, manufacturing, and adjuvant biology.
Possible research activities include:
- HIV vaccine research and development to enable down-selection of final HIV immunogens
- Preclinical testing and vaccine and immunogenicity optimization studies
- Upstream and downstream process and product development
- Generation of cell/plasmid/viral master banks
- Immunogen/adjuvant formulations
Applicants may choose to partner with biotech/pharma or a contract manufacturing organization (CMO) to facilitate process development and manufacturing.
In combination, those activities will support:
- All stages of vaccine technology or platform research and development through facilitation of proof-of-concept studies with appropriate animal models [e.g., nonhuman primate (NHP), human immunoglobulin knock-in mice] with minimal down-selection of the final lead candidate alone or in combination with adjuvant(s). NIAID encourages studies in NHPs be limited to immunogenicity without a challenge component to determine efficacy.
- All product development stages including technology transfer, development of in-process tests, qualification or validation of release assays, formulation studies, cGMP manufacturing, fill-finish, and product delivery that are guided with a risk assessment plan to mitigate risks that may impact product integrity.
- Stability testing program based on FDA and International Council of Harmonisation (ICH) Q1A (R2) guidance, and cGMP product release and storage.
- Investigational new drug- (IND-) enabling studies, e.g., good laboratory practices toxicity studies for regulatory submissions.
Applicants must also account for these aspects of the IPCAVD Program:
- Product Manufacturing Project, including a Product Development Plan
- Clinical Development Plan where applicants must identify a suitable clinical partner to test the proof-of-concept in early-stage vaccine clinical trials by year 5. Identifying a potential clinical partner will ensure that decisions made during the product development stage are aligned with clinical trial requirements. Investigators must initiate a clinical trial under other support mechanisms no later than year 5 of this award.
- A milestone plan with Go/No-Go criteria that must be met by the end of year 2 of the award to allow manufacturing to begin no later than year 3.
NIH program staff will evaluate the progress of research towards the stated Go/No-Go criteria for cGMP manufacturing. Those who successfully meet their criteria will be eligible for 3 additional years of funding, for a total of 5 years. Grantees who do not meet Go/No-Go criteria for cGMP manufacturing will have adjusted budget periods for years 3, 4, and 5 and may be at a reduced rate.
Applicants must also describe how product storage and stability programs will be managed in compliance with cGMP and ICH regulations for early phase clinical trials.
The research programs funded under this FOA will be composed of multiple components, which include:
Administrative Core: Provides overall management, coordination, and supervision of the program. The Core administers the plan provided in the application to address short- and long-term program management.
Research Projects: Each application must propose a minimum of two projects with one project focusing on the product manufacture strategy. Applicants may choose to partner with biotech/pharma or a CMO. In coordination with the grantee, DAIDS will manage a Quality Systems Audit for acceptability and regulatory compliance of the proposed manufacturing facility before initiating cGMP activities.
Scientific Core(s): Applicants should propose one or more optional scientific cores as a resource to the proposed multiproject program, and each proposed core must support at least two research projects.
External Advisory Committee (EAC): Soon after award, an EAC consisting of at least three independent experts in the relevant areas of research will be assembled.
Nonresponsive Application Areas
Refer to the FOA for a list of nonresponsive research areas which, if included, will cause NIAID to consider your applications nonresponsive and not review it. Additionally, NIAID will consider applications without the above research components to be nonresponsive and will not review them.
Submission and Award Information
Applications are due on March 15, 2023, with subsequent due dates on March 15, 2024, and March 14, 2025, by 5 p.m. local time of the applicant organization. Application budgets are limited to $3 million in annual direct costs for each of the first 2 years of the award. Application budgets also need to reflect the actual needs of the proposed program.
Send questions to Dr. Sujata Vijh, NIAID’s scientific/research contact at firstname.lastname@example.org or 301-761-7713. Direct peer review related questions to Dr. Poonam Pegu at email@example.com or 240-292-0719.