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Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Related Experiment Video

Updated: Mar 6, 2026

Production of E. coli-expressed Self-Assembling Protein Nanoparticles for Vaccines Requiring Trimeric Epitope Presentation

Production of E. coli-expressed Self-Assembling Protein Nanoparticles for Vaccines Requiring Trimeric Epitope Presentation

Published on: August 21, 2019

Progress in HIV vaccine development.

Denise C Hsu^1,2,3, Robert J O'Connell^1,2

¹a Armed Forces Research Institute of Medical Sciences , Bangkok , Thailand.

Human Vaccines & Immunotherapeutics

|March 11, 2017

Summary

This summary is machine-generated.

Developing an effective HIV-1 vaccine is crucial. Promising strategies include inducing broadly neutralizing antibodies (bnAb) and functional antibodies, with several approaches advancing in clinical and preclinical development.

Keywords:

HIV RV144 broadly neutralizing antibodies functional antibodies vaccine

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Conformational Evaluation of HIV-1 Trimeric Envelope Glycoproteins Using a Cell-based ELISA Assay

Conformational Evaluation of HIV-1 Trimeric Envelope Glycoproteins Using a Cell-based ELISA Assay

Published on: September 14, 2014

Area of Science:

Immunology
Vaccinology
Virology

Background:

The urgent need for an effective human immunodeficiency virus type 1 (HIV-1) vaccine to combat the ongoing epidemic.
Limited success in past efficacy trials, with only one trial (RV144) demonstrating efficacy.
A potential protective mechanism involves inducing functional antibodies targeting the V1V2 region of the HIV envelope.

Purpose of the Study:

To review current strategies for generating protective immunity against HIV-1.
To discuss the advancement of broadly neutralizing antibodies (bnAb) and functional antibodies in vaccine development.
To highlight the promising future prospects for preventive HIV-1 vaccine development.

Main Methods:

Review of current HIV-1 vaccine research and development approaches.
Analysis of strategies for inducing broadly neutralizing antibodies (bnAb) and functional antibodies.
Discussion of ongoing and upcoming clinical trials, including passive immunization and prime/boost strategies.

Main Results:

Passive immunization with bnAb has progressed to Phase II clinical trials.
Induction of bnAb via Env trimer mimics or B-cell lineage design is in preclinical stages.
Optimization of functional antibodies will be evaluated in the upcoming HVTN702 efficacy trial.

Conclusions:

Ongoing advancements in prime/boost strategies, mosaic immunogens, and replication-competent vectors are enhancing HIV-1 vaccine development.
Emerging strategies for inducing bnAb contribute to the promising outlook for a preventive HIV-1 vaccine.
The diverse and evolving approaches in HIV-1 vaccine research signal a hopeful future for prevention.