ImportanceThe protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown.ObjectiveTo evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults.Design, Setting, and ParticipantsA multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021.InterventionsIn cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection.Main Outcomes and MeasuresThe primary outcome was polymerase chain reaction–confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed.ResultsIn cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths.Conclusions and RelevanceIn this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19–related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price.Trial Registrationisrctn.org Identifier: IRCT20210303050558N1
Background: Incarcerated people are at a disproportionate risk of contracting HIV. We estimated the prevalence and correlates of HIV testing among incarcerated people with a history of HIV-related high-risk behaviours in Iran. Methods: Data for this analysis were obtained from three consecutive nationwide bio-behavioural surveillance surveys of a random sample of incarcerated people in 2009 (n = 5,953), 2013 (n = 5,490) and 2017 (n = 5,785). History of testing for HIV in the previous 12 months was the primary outcome variable and was examined among those with a history of HIV-related high-risk behaviours (i.e., having multiple sex partnership, injection drug use practices, or history of having a tattoo). The outcome variable was divided into three categories: Never tested for HIV, ever tested for HIV inside the prison, and ever tested for HIV outside the prison. We used multivariable multinomial logistic regression models to examine factors associated with HIV testing. Results: Overall, 8,553 participants with a history of HIV-related high-risk behaviors with valid responses to the HIV testing question, were included in the analysis. Although HIV testing inside prison has increased (23% [2009], 21.5% [2013], and 50.3% [2017]: P-value <0.001), the prevalence of HIV testing outside prison has decreased (7.7% [2009], 7.5% [2013], 4.1% [2017]: P-value <0.001) over time. Our multivariable multinomial regression model showed older age (Relative-risk ratio [RRR]: 1.24, 95% Confidence Intervals [CI]: 1.05, 1.47), history of previous incarceration (RRR: 1.46, 95% CI: 1.24, 1.71), currently receiving methadone maintenance therapy inside prison (RRR: 2.09, 95% CI: 1.81, 2.43), having access to condoms inside prison (RRR: 1.42, 95% CI: 1.20, 1.68) and sufficient HIV knowledge (RRR: 1.74, 95% CI: 1.47, 2.05) were significantly associated with an increased probability of having an HIV test in the last 12 months inside prison. Conclusions: HIV testing among Iranian high-risk prisoners has increased from 2009 to 2017. However, HIV testing remains considerably low, and half of incarcerated people with a history of HIV-related high-risk behaviours had never tested for HIV inside prison. Evidence-based programs efforts are needed to optimize HIV testing both inside and outside prisons and identify those at greater risk of HIV.
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