Development and Production of HIV Vaccines and Adjuvants

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

HIV-1 vaccines designed to confer immunity against multiple strains of HIV will be developed at the VPP, manufactured through the VCMP for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may confer broad immunity as defined by inducing antibodies that may neutralize multiple HIV isolates. If these clinical trials demonstrate safety and immunogenicity of the vaccines, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials at larger scale. Vaccines under development at the VPP include protein subunits based on stabilized Env trimers and conjugates of the HIV fusion peptide to a recombinant fragment of the tetanus toxoid. The immunogenicity of protein subunit vaccines can be improved with the use of adjuvants co-administered with the vaccines, and both alum and Carbopol-lecithin adjuvants have been produced for human use or are in development for subsequent GMP production. Joint development between the VPP and VCMP has led to technology transfer of the process and sterilization process of Adjuplex which will be manufactured later in 2021 and used in a clinical trial with previously manufactured HIV vaccines; Trimer 4571, Trimer 6931, and FP8-rTTHC.