Phase IIb / III HIV vaccine developed by GSK / Sanofi failed!

On February 3, NIH announced that its National Institute of allergy and infectious diseases (NIAID) has stopped a clinical trial of HIV vaccination in South Africa The reason is that the data and safety monitoring board (DSMB) found in its mid-term review that the vaccine programme for the study did not prevent HIV But the Commission did not express any concerns about the safety of vaccination participants The IIb / III study, known as hvtn702 (or uhambo), began in 2016 in South Africa to test a primary enhanced vaccination programme against HIV infection South Africa has one of the highest rates of HIV infection, with more than 20 per cent of adults aged 15-49 living with HIV In 2018, 240000 people in South Africa were living with HIV In the hvtn702 study, 5407 HIV negative volunteers, aged 18-35, were recruited from 14 regions in South Africa, all of whom were sexually active men and women The volunteers in the study were randomly assigned to receive a study vaccine regimen or placebo, and received six injections within 18 months Throughout the trial, participants' safety was strictly monitored and medical standards for HIV prevention were provided, including the use of pre exposure oral prophylaxis (PREP) The interim analysis, released on January 23, included data from 2694 volunteers who received the research vaccine program and 2689 volunteers who received placebo injections At least 60% of the volunteers took part in the study for more than 18 months, and the vaccine program had enough time to stimulate the immune response The results showed that there were 129 HIV infections among the vaccinated and 123 HIV infections among the placebo vaccinated DSMB concluded that the study vaccine did not show any efficacy Vaccination is not recommended and research should not continue NIH noted that there was no evidence of a decrease or increase in infection rates after vaccination, and there was no significant difference between the vaccine and placebo groups At the same time, the review found no potential safety hazards It is reported that hvtn702 program consists of two experimental vaccines: one is based on Canary pox virus vector vaccine, known as alvac-hiv; the other is a two-component gp120 protein subunit vaccine with adjuvant, which can enhance the immune response of human body to the vaccine Alvac-hiv is from Sanofi Pasteur, and the protein subunit vaccine is provided by GSK A pilot study, hvtn100, found that hvtn702 was safe and could induce high and enhanced titers of antibodies against several HIV strains prevalent in southern Africa NIH points out that the program is the only vaccine program ever to show protection against HIV Previous trials in Thailand, RV144, showed a 31.2% reduction in HIV infection in the vaccinated group compared with the uninoculated group This is the first HIV vaccine effective clinical trial in the world in the past seven years This time, the researchers modified the vaccine for the South African study, which adapted to the most common HIV subtype C in the African pandemic; and combined the protein subunit vaccine in hvtn702 with MF59 (adjuvant), hoping to produce a stronger and more lasting immune response Animal experiments have shown that MF59 can reduce the infection rate of simian immunodeficiency virus In addition, the vaccine program includes increased injections at one year and 18 months to extend the early protective effects observed in previous studies The scheme used in hvtn702 trial is different from that used in other HIV vaccine studies In the imbokodo and mosaico studies of Janssen Pharmaceutical, it used "mosaic" HIV vaccine to obtain different HIV gene sequences, and combined these sequences by artificial design optimization, so as to induce the immune response to multiple strains of HIV NIH is investing in a variety of AIDS prevention methods, including proof of concept amp test, which is studying the research antibody for intravenous injection and HIV prevention, and two large-scale tests, which are testing a long-term, injectable antiretroviral drug, cabotegravir, for HIV prevention The long-term HIV prevention products under development include implants, vaginal rings, a combination of broad neutralizing antibodies (bNAb) and multi-functional products for HIV prevention Reference sources: 1 High hopes dashed: HIV vaccine made from GSK, Sanofi components floats massive study 2 Experimental HIV vaccine gains effective in study, NIH says 3 Experimental HIV vaccine region effective in preventing HIV 37