RESUMEN
This is a summary of a publication about the ENSEMBLE trial of the Janssen Ad26.COV2.S vaccine against COVID-19, which was published in the New England Journal of Medicine in April 2021. The ENSEMBLE study started in September 2020 and is still ongoing. The study compared the effectiveness of the vaccine to a placebo in 43,783 adults from Latin America, South Africa, and the United States. Of those, 19,630 got a single dose of the vaccine. Compared to the placebo, the vaccine prevented: 66.9% of moderate to severe-critical COVID-19 cases after 14 days66.1% of moderate to severe-critical COVID-19 cases after 28 days85.4% of severe COVID-19 cases after 28 days100% of people with severe COVID-19 from needing to go to hospital for treatment None of the vaccinated participants died from COVID-19. There were 5 people who got the placebo who died from COVID-19. The vaccine was similarly effective in people from all age groups and different countries, including South Africa, where most cases were caused by the beta variant of the virus that originated there. The people in the study who got the vaccine who went on to get COVID-19 generally had milder and fewer symptoms than those who got the placebo. In most people, the vaccine started working after about 2 weeks. After receiving the vaccine, some people experienced pain at the injection site, headache, tiredness, muscle pain, and nausea. In most cases, these were mild and went away within a few days. Serious side effects were very rare. Blood clots, seizures, and tinnitus were very rare but were more common in the people who got the vaccine than in those who got the placebo. At the time of the study, it was not clear if these were caused by the vaccine or not. ClinicalTrials.gov NCT number: NCT04505722.
RESUMEN
BACKGROUND: Several novel tuberculosis vaccines are currently in clinical trials, including AERAS-402, an adenovector encoding a fusion protein of Mycobacterium tuberculosis antigens 85A, 85B, and TB10.4. A multicentred trial of AERAS-402 safety and immunogenicity in healthy infants was conducted in three countries in sub-Saharan Africa, using an adaptive design. METHODS: In a double-blind, randomised, placebo-controlled, dose-finding trial, we enrolled BCG-vaccinated, HIV-uninfected infants aged 16-26 weeks. Infants in the safety/dose-finding phase received two doses of AERAS-402 across three dose levels, or placebo, intramuscularly on days 0 and 28. Infants in the expanded safety phase received three doses of the highest dose level, with the 3rd dose at day 280. Follow up for safety and immunogenicity was for up to two years. RESULTS: We enrolled 206 infants (52 placebo and 154 AERAS-402 recipients) into the dose-finding phase and 281 (141 placebo and 140 AERAS-402 recipients) into the expanded safety phase. Safety data were acceptable across all dose levels. No vaccine-related deaths were recorded. A single serious adverse event of tachypnoea was deemed related to study vaccine. Antibodies directed largely against Ag85A and Ag85B were detected. Low magnitude CD4+ and CD8+ polyfunctional T cell responses were observed at all dose levels. The addition of a third dose of AERAS-402 at the highest dose level did not increase frequency or magnitude of antibody or CD8+ T cell responses. CONCLUSIONS: AERAS-402 has an acceptable safety profile in infants and was well tolerated at all dose levels. Response rate was lower than previously seen in BCG vaccinated adults, and frequency and magnitude of antigen-specific T cells were not increased by a third dose of vaccine.