Mexico Joins HIV Vaccine Clinical TrialBy Miriam Bello | Mon, 05/03/2021 - 13:14
International clinical trial “Mosaico,” a large study evaluating the efficacy of an experimental vaccine regimen to prevent HIV infection, arrives to Mexico. Mosaico, or HPX3002/HVTN 706, is a Janssen’s sponsored study taking place in North America, Latin America and the EU.
Mosaico will enroll cisgender men and transgender people who have sex with cisgender men and/or transgender people, explains the study’s official website. A complementary study in women called HPX2008/HVTN 705 or Imbokodo launched in 2017 in five southern African countries and is still ongoing.
According to NCBI, Mosaico is the third study (corresponding to phase 3 of clinical trials) of this vaccine development. Previous studies, called Approach and Ascent, applied four doses of the vaccine composition (Ad26Mos.HIV and bivalent gp140 regimen) to healthy volunteers and observed a negative HIV diagnosis two years later. “No safety issues were reported and no HIV infections have been identified in any of the 65 participants up to week 144.” Nature explained that the shots contain a modified common cold virus carrying synthetic versions of three HIV genes. “As an added boost to help the body produce antibodies against HIV, the Mosaico team added two synthetic proteins — based on proteins produced by HIV strains common in Africa, the Americas, the EU and Australasia — to the last two doses in the series.”
About Phase 3
The latest Mosaico study will enroll 3,800 participants across eight countries, including Argentina, Italy, Mexico, Poland and the US. Half of the participants will get four vaccine injections over the course of a year and the other half will receive a placebo.
In Mexico, INCMNSZ, the Condesa Iztapalapa Specialized Clinic, the Benjamín Sepúlveda Amor Clinic in Mexico City, the Guadalajara Civil Hospital and UNAMIS, a private clinic in Merida, will participate in the study. Together, the health centers aim to recruit over 250 healthy men between the ages of 18 and 60. So far, 65 volunteers from Mexico City have registered, out of the 150 expected. The Mosaico team hopes that their vaccine will help to protect at least 65 percent of the study participants. Results are expected to be delivered by 2023.
The Ministry of Health estimates that Mexico registers two new HIV cases every hour. Despite its importance, the current health agenda does not seem to include HIV among its priorities. An article by The Lancet exposed that a government fund that supported several initiatives in the fight against HIV/AIDS in Mexico was cut in 2019, leading to a shortage of antiretroviral drugs that was later blamed on issues related to the changes to the centralized purchasing scheme being implemented at the time. Back then, the government had recently introduced INSABI to replace Seguro Popular, which was in charge of supplying antiretrovirals to patients, but the new institution failed to do so. Patients in Mexico City protested the decision and prompted doctors and researchers from national institutes and from Condesa Clinic, a specialized clinic to treat HIV/AIDS, to find replacement treatments.
Activists at Mexico City fear stigma in the vaccine’s candidate selection process, according to an article by Expansion. However, they see the vaccine as a positive step towards the provision of dignified attention to the disease, especially after the drug shortages they experienced last year.