Increased Protein Expression Vector for Vaccine Applications

An expression vector with a unique promoter that results in higher level of protein expression than vectors currently in use is available for licensing from the NIH. The elevated levels of expression are achieved through use of a specific promoter, known as CMV/R, in which the Human T-Lymphotrophic Virus (HTLV-1) Long Terminal Repeat (LTR) R-U5 region is substituted for a portion of the intron downstream of the CMV immediate early region 1 enhancer (Barouch et al., 2005). Sequences of 95% or better homology to CMV/R can be used as well.

A High-Yield Perfusion-Based Transient Gene Expression Bioprocess

Currently, fed-batch processes are the most commonly used bioprocesses in transient gene expression (TGE) vaccine manufacturing. However, because fed-batch processes keep all the cells and protein product in the vessel throughout the run, some limitations are intrinsic. First, waste products like cell debris or other unwanted small molecules accumulate in the vessel with a potential to disrupt the cell growth, protein production, and the stability of the generated protein of interest.

Hybridoma Cell Lines 2A4 And 5B12 Against Puromycin

Protein translation is a central cellular function attracting increasing attention from cell biologists as they integrate gene product specific information into a systems view of cellular function. Scientists at NIAID developed the puromycin-specific antibodies that allow for the specific detection of puromycin-containing nascent polypeptides via standard immunofluorescence or flow cytometry.

Multi Protein Nanoparticle Monkeypox Vaccine

In 2022, the World Health Organization declared an atypical outbreak of monkeypox (Mpox), which has caused approximately 30,000 cases of Mpox infection within the United States as of April 2023. Mpox represents a current threat to public health, and there is an immediate need for an effective vaccine. To address this, NIAID has developed a vaccine approach comprising virus-like nanoparticles coated with modified Mpox proteins.

Dual-Germline Antibody Engager Chimeric HIV–1 Immunogens

Despite four decades of intensive research, a safe and effective HIV-1 vaccine remains elusive due to the extreme difficulty in eliciting broadly neutralizing antibodies (bNAbs), which recognize and block HIV-1 from entering healthy cells. Only rare natural HIV-1 envelopes (Envs) promote the activation and expansion of naive B cells expressing unmutated germline antibodies of various bNAb lineages, but they typically do so for a single lineage for the same neutralization site.

Replication-Competent Adenovirus Type-4 HIV Env Vaccines and Their Use

NIAID, IAVI, Emergent, and Scripps have developed two recombinant adenovirus type 4 (Ad4) vector-based vaccine candidates. These replicating Ad4 vector-based candidates have shown improved activity against tier 2 HIV-1 isolates in experimental animals. Tier 2 isolates are among the most prevalent in infected populations. The two candidates, Ad4-Env150KN and Ad4-Env145NFL, incorporate novel design features based on Ad4-EnvC150 (1086c). Specifically, the truncation of the cytoplasmic tail of Env increases cell surface expression and has resulted in improved antigenicity from both candidates.

Humanized Murine Monoclonal Antibodies That Neutralize Type-1 Interferon (IFN) Activity

Interferons (IFNs) are a family of cytokines that function in response to an immune challenge such as a viral or bacterial infection. Type I IFNs are produced by immune cells (predominantly monocytes and dendritic cells) as well as fibroblasts and signal through a specific cell surface receptor complex (IFNAR) that consist of IFNAR1 and IFNAR2 chains. Type-I IFNs exert several common effects including antiviral, antiproliferative, and immunomodulatory activities. However, Type I IFNs also have pro-inflammatory effects, especially in the presence of TNF-a.

Replication-Competent Adenovirus Type 4 SARS-CoV-2 Vaccines and Their Use

NIAID has produced recombinant adenovirus type 4 (Ad4), SARS-CoV-2 spike, vectors for administration to humans. These recombinant vaccines permit rapid development of high levels of neutralizing antibodies to SARS-CoV-2 in experimental animals. This vaccine is designed to improve the durability of the immune response by inducing mucosal and systemic immunity. Further, this system should be incredibly simple and efficient when producing vaccine at scale. This technology is available for licensing for commercial development in accordance with 35 U.S.C.

Continuous Cell Lines Persistently Expressing High Levels of Native HIV-1 Envelope Trimers on their Surface Membrane

Transduced human cell lines expressing high levels of native HIV-1 Envelope on their surface membrane, in the unmodified or interdomain stabilized form. These cell lines provide a stable source of native HIV-1 envelope for multiple uses, including the high-efficiency production of virus-like particles (VLPs) for use as vaccines, testing new inhibitors or neutralizing antibodies, or identifying/capturing B cells that produce broadly neutralizing antibodies from infected/vaccinated humans or animals.

Improvement of Broadly HIV-Neutralizing Antibodies; Anti-HIV-1 Antibody VRC01.23 for Prevention or Treatment of HIV Infection

Scientists at NIAID have developed broadly neutralizing antibodies (bNAbs) with enhanced neutralizing activity against HIV-1. Specifically, previously unknown gp120 interactions with a newly elucidated quaternary receptor (CD4)-binding site in the HIV-1 envelope have been discovered by engrafting the extended heavy-chain framework region 3 (FR3) loop of VRC03 onto several potent bNAbs (including VRC01, VRC07 and N6).
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