Johnson & Johnson will launch a series of human trials for an experimental Human Immunodeficiency Virus (HIV) vaccine in the US and Europe within the year. The pharmaceutical giant, along with GlaxoSmithKline, applied for a Food and Drug Administration approval in April.
The new vaccine is a tetravalent mosaic. The goal of the vaccine is to raise the body’s immunity against different varieties of HIV. What’s new with this vaccine is that its “mosaic” qualities carry proteins that defend against multiple strains of the virus. In the company’s previous animal trials, the company has published results of two-thirds success rates.
In the clinical trials set for this year, there will be at least 3,800 male participants. In the entire TRAVERSE study, this is already Phase 2. The participants will have six shots over four sessions. Results of these trials will be published in 2023.
The goal of the study is to build immunity against HIV to prevents Acquired Immune Deficiency Syndrome (AIDS). HIV attacks the cells of the immune system lowering the body’s defense against illnesses. AIDS, or late-stage HIV infection, is when the patient’s immune system is destroyed and no longer able to protect the body. Once a patient reaches this stage, any kind of infection, minor or major, becomes life-threatening.
According to UNAIDS, the joint United Nations program on HIV/AIDS, there are 36.9 million people with HIV in 2017. At least 1.8 million of those infected are children with ages 15 years old and below. On a positive note, there’s a 51% decrease of AIDS-related deaths in 2017 compared to 2004, when the threat of the virus recently peaked.
The development of the tetravalent mosaic HIV vaccine was dubbed as the TRAVERSE study. In 2018, J&J presented results of the study at the HIV Research for Prevention Conference in Madrid, Spain. According to J&J, the results showed significant and promising results.
Based on TRAVERSE analysis, the tetravalent mosaic vaccine regimen is safe and well-tolerated at the study’s 28th week. The Phase 1 clinical trial had 201 male participants from the US and Rwanda. The participants received prime vaccine shots at week intervals: Week 0, 12, 24, and 28. Four groups received different types of the tetravalent mosaic vaccine and placebos.
The trials started last July 2016. It’s initial completion date, the date its last patient was examined or received the intervention, was last August 2018. The final results and the completion date is expected in June 2021.
The Imbokodo Study
Since the TRAVERSE study focused on male participants, another variation of the vaccines targeted female participants. The trials are under the study named “Imbokodo.” J&J’s child company, Janssen Pharmaceuticals collaborated with the HIV Vaccine Trials Network (HVTN) to test the vaccine regimen in 26 sites in 5 countries in Africa.
A total of 2,600 women participated in the trials. The women participants are from ages 18 to 36 years. The participants received six injections over 12 months. The vaccine teaches the immune system to recognize the virus and fight it with antibodies.
The participants are being monitored by the research team on site. According to HVTN, initial results show that antibodies formed but has not yet ensured protection. HIV detection methods find it recognized the HIV antibodies as the virus itself. In this case, using the HIV fingerprick tests on the participants showed that they are positive with HIV. However, further lab testing identified that the false positives were Vaccine-Induced Seropositive (VISP) test results.
The participants have regular HIV testing during the trials. Once a participant finishes their trials, she can still request for the special tests from the company.
The study was named after an isiZulu word that means “rock.” A popular African proverb inspired it: “You strike the women, you strike the rock!”
The Imbokodo study started last November 2017. Its last participant will receive her last procedure in November 2020 with expected results to be published in 2022.
Multiple companies and organizations are looking to find ways to prevent the virus and cure the disease. In 2017, there was a hopeful way to cure HIV and AIDS through gene-editing using the Clustered Regularly Interspaced Short Palindrome Repeats (CRISPR) technology. It proved to be highly successful during its animal trials, but it has not yet progressed to human clinical trials.