The previously planned analysis of the study results clearly shows that the number of people who have become infected with HIV is very similar in both arms of the study (vaccine or placebo), therefore it has NOT been possible to demonstrate the efficacy of this vaccine to prevent HIV infection.

For this reason, the independent Committee that periodically evaluates the data of the study (DSMB) has recommended us, the investigators and the sponsor, to stop the study, since these findings are consistent and it is not possible that they will be modified with more follow-up time. On the other hand, the vaccine proved to be safe, that is, it was not associated with significant adverse effects.

Once again, we want to thank the commitment and effort of the participants in this research, our respect and admiration for them, together with our commitment to continue monitoring them if they consider it so. A special recognition to the Community team, to the ClinSex and Emerging Diseases team of the JM Ramos Mejia Hospital; and each one of the members of the CICAL team, for their commitment and hard work of excellence to make this study possible.

Official communiqués of HVTN network and Johnson & Johnson:

https://www.jnj.com/janssen-and-global-partners-to-discontinue-phase-3-mosaico-hiv-vaccine-clinical-trial

https://www.hvtn.org/news/news-releases/2023/01/phase-3-mosaic-based-investigational-hiv-vaccine-study-discontinued-following-disappointing-results-planned-data-review.html

VAC31518COV3001; fase 3

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

This study is being conducted under the sponsorship of Janssen (Janssen Vaccines & Prevention B.V) in collaboration with Operation Warp Speed (OWS), which also encompasses the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the COVID-19 Prevention Trials Network (COVPN)

The primary objective of this study is to demonstrate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed, moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults. Ad26.COV2.S (previously known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication-incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein.

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men.

Summary of study: HPTN 083 is a multi-site, double blind, two-arm, randomized (1:1), controlled non-inferiority trial of the efficacy of CAB LA compared to daily oral tenofovir disoproxyl fumarate (TDF)/emtricitabine (FTC) for HIV prevention. The purpose of this study is prove efficacy of CAB LA compared to daily oral tenofovir disoproxyl fumarate (TDF)/emtricitabine (FTC) for HIV prevention to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). The study population is HIV-uninfected MSM and TGW at risk for acquiring HIV infection, ages 18 or older, approximately 5000, 2500 per arm. The duration of the study is approximately 7.5 years.

Randomized master protocol for the treatment of COVID-19 with immunomodulators.

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents as treatment for moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). The objectives of the research are to evaluate each agent in relation to the speed of recovery, mortality, severity of the disease and use of hospital resources. Each agent will be evaluated as a therapeutic adjunct to standard treatment (SoC) when used in local clinics, including remdesivir (supplied). The SoC may change during the course of the study based on other research findings. Comparisons between agents is not an objective of the investigation. The study population corresponds to moderately to severely ill patients infected with the 2019 coronavirus disease virus (COVID-19). Recruitment will focus on patients already hospitalized for the treatment of COVID-19 infection as well as patients who are being treated for COVID-19 infection in Emergency Rooms while awaiting admission to the hospital. Patients who are in and out of ICUs are included in the study population.

Prospective study of acute immune responses to SARS-CoV-2 infection.

The main objective of the study is to generate standardized data sets that characterize the quality, magnitude and kinetics of humoral immune responses to a SARS-CoV-2 infection in asymptomatic and symptomatic participants (hospitalized and non-hospitalized) who present a variety of clinical outcomes to prepare similar evaluations during trials of immune prevention strategies and to characterize innate and cellular immune responses to a SARS-CoV-2 infection during such an infection in asymptomatic and acutely symptomatic participants (hospitalized and not hospitalized).

Delivery of HIV care through telemedicine in public hospitals in Buenos Aires, Argentina during COVID-19 pandemic: implementation research.

This is a Prospective observational study design using mixed methods with a hybrid type-3 design using RE-AIM framework. The goals of this study are to use Implementation Facilitation to implement the telemedicine intervention in Buenos Aires City public hospital network in the context of COVID-19 pandemic and to generate the scientific evidence needed to disseminate VCT adapted to HIV care in public hospitals. Because this hybrid type 3 study.

Therapeutics for Inpatients with COVID-19 (TICO). A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19.

TICO is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression. Trials within this protocol will be phase III, adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of this protocol.