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Based on the available scientific knowledge and pre-clinical evidence, the University of Massachusetts Medical School has initiated multicenter, phase I clinical trial to investigate an HIV vaccine that might prevent HIV infection.
Despite the publication of several promising strategies, fewer vaccine candidates have been investigated in human clinical trials, until this date.
The synthetic DNA vaccine has been developed by Dr. Shan Lu, MD, Ph.D., Professor of Medicine and Biochemistry & Molecular Pharmacology at the University of Massachusetts (UMass). In the study, researchers want to harness the power of DNA vaccines by inducing the pathogenic antigen-specific immune response against HIV.
This vaccine has been designed by using limited DNA sequences of HIV to induce an immune response, followed by a booster protein vaccine mimicking the viral DNA proteins.
Kickstarted in 2018, the clinical trials are being conducted by the researchers at the HIV Vaccine Trials Network. The early study will enroll healthy subjects who are at low-risk of acquiring HIV, and the participants will receive frequent counseling for HIV prevention at four clinical trial sites.
In the Phase I-clinical trial, the safety and tolerability of the experimental vaccine are to be investigated, over 6 to 12 months. The double-blinded study involves two groups of participants; one group has been assigned to receive the protein vaccine combined with an adjuvant GLA-SE to boost the immune response, whereas the comparator group participants are assigned to receive the DNA and protein vaccines, simultaneously. The aim of this study design is to ascertain the efficacy/immunogenicity of both DNA and protein vaccines via induction of cell-mediated immune response and antibody activation against HIV pathogen.
The researchers have developed a prime-boost method that is capable of producing antibodies against several viral antigens. Upon vaccination, the vaccine prompts the B-lymphocytes to produce the HIV antigen-specific antibodies. With the combined power of prime and boost vaccines, the induced-antibodies target the Achilles' heel of HIV effectively, and the induced immune response/efficacy may persist for years.