Imperial College London

DrLeilaJanani

Faculty of MedicineSchool of Public Health

Research Fellow (Clinical Trials Statistician)
 
 
 
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l.janani

 
 
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Stadium HouseWhite City Campus

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Summary

 

Publications

Publication Type
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17 results found

Munro APS, Feng S, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Qureshi E, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kanji N, Libri V, Llewelyn MJ, McGregor AC, Maallah M, Minassian AM, Moore P, Mughal M, Mujadidi YF, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Bawa T, Saralaya D, Sharma S, Sheridan R, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN, COV-BOOST study groupet al., 2022, Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial, Lancet Infectious Diseases, Vol: 22, Pages: 1131-1141, ISSN: 1473-3099

BACKGROUND: Some high-income countries have deployed fourth doses of COVID-19 vaccines, but the clinical need, effectiveness, timing, and dose of a fourth dose remain uncertain. We aimed to investigate the safety, reactogenicity, and immunogenicity of fourth-dose boosters against COVID-19. METHODS: The COV-BOOST trial is a multicentre, blinded, phase 2, randomised controlled trial of seven COVID-19 vaccines given as third-dose boosters at 18 sites in the UK. This sub-study enrolled participants who had received BNT162b2 (Pfizer-BioNTech) as their third dose in COV-BOOST and randomly assigned them (1:1) to receive a fourth dose of either BNT162b2 (30 μg in 0·30 mL; full dose) or mRNA-1273 (Moderna; 50 μg in 0·25 mL; half dose) via intramuscular injection into the upper arm. The computer-generated randomisation list was created by the study statisticians with random block sizes of two or four. Participants and all study staff not delivering the vaccines were masked to treatment allocation. The coprimary outcomes were safety and reactogenicity, and immunogenicity (anti-spike protein IgG titres by ELISA and cellular immune response by ELISpot). We compared immunogenicity at 28 days after the third dose versus 14 days after the fourth dose and at day 0 versus day 14 relative to the fourth dose. Safety and reactogenicity were assessed in the per-protocol population, which comprised all participants who received a fourth-dose booster regardless of their SARS-CoV-2 serostatus. Immunogenicity was primarily analysed in a modified intention-to-treat population comprising seronegative participants who had received a fourth-dose booster and had available endpoint data. This trial is registered with ISRCTN, 73765130, and is ongoing. FINDINGS: Between Jan 11 and Jan 25, 2022, 166 participants were screened, randomly assigned, and received either full-dose BNT162b2 (n=83) or half-dose mRNA-1273 (n=83) as a fourth dose. The median age of these participants was 70

Journal article

Liu X, Munro APS, Feng S, Janani L, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dejnirattisai W, Dodd K, Enever Y, Qureshi E, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Holliday K, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Serafimova T, Saralaya D, Screaton GR, Sharma S, Sheridan R, Sturdy A, Supasa P, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Lambe T, Nguyen-Van-Tam JS, Cornelius V, Snape MD, Faust SN, COV-BOOST study groupet al., 2022, Persistence of immunogenicity after seven COVID-19 vaccines given as third dose boosters following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK: Three month analyses of the COV-BOOST trial, Journal of Infection, Vol: 84, Pages: 795-813, ISSN: 0163-4453

OBJECTIVES: To evaluate the persistence of immunogenicity three months after third dose boosters. METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of seven COVID-19 vaccines used as a third booster dose. The analysis was conducted using all randomised participants who were SARS-CoV-2 naïve during the study. RESULTS: Amongst the 2883 participants randomised, there were 2422 SARS-CoV-2 naïve participants until D84 visit included in the analysis with median age of 70 (IQR: 30-94) years. In the participants who had two initial doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd), schedules using mRNA vaccines as third dose have the highest anti-spike IgG at D84 (e.g. geometric mean concentration of 8674 ELU/ml (95% CI: 7461-10,085) following ChAd/ChAd/BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT)). However, in people who had two initial doses of BNT there was no significant difference at D84 in people given ChAd versus BNT (geometric mean ratio (GMR) of 0.95 (95%CI: 0.78, 1.15). Also, people given Ad26.COV2.S (Janssen; hereafter referred to as Ad26) as a third dose had significantly higher anti-spike IgG at D84 than BNT (GMR of 1.20, 95%CI: 1.01,1.43). Responses at D84 between people who received BNT (15 μg) or BNT (30 μg) after ChAd/ChAd or BNT/BNT were similar, with anti-spike IgG GMRs of half-BNT (15 μg) versus BNT (30 μg) ranging between 0.74-0.86. The decay rate of cellular responses were similar between all the vaccine schedules and doses. CONCLUSIONS: 84 days after a third dose of COVID-19 vaccine the decay rates of humoral response were different between vaccines. Adenoviral vector vaccine anti-spike IgG concentrations at D84 following BNT/BNT initial doses were similar to or even higher than for a three dose (BNT/BNT/BNT) schedule. Half dose BNT immune responses were similar to full dose responses. While high antibody tires are desirable in situations of high transmission of new

Journal article

Jones T, Janani L, Gordon A, Al-Beidh F, Antcliffe Det al., 2022, A novel role for cytochrome P450 epoxygenase metabolites in septic shock, Critical Care Explorations, Vol: 4, ISSN: 2639-8028

Objectives Oxylipins are oxidative breakdown products of cell membrane fatty acids. Animal models have demonstrated that oxylipins generated by the P450 epoxygenase pathway may be implicated in septic shock pathology. However, these mediators are relatively unexplored in humans with septic shock. We aimed to determine if there were patterns of oxylipins that were associated with 28-day septic shock mortality and organ dysfunction. Design Retrospective analysis of samples collected during the Vasopressin vs. Norepinephrine as Initial Therapy in Septic Shock trial.Setting Intensive Care Units in the United KingdomPatients Adults recruited within six hours of onset of septic shock. Interventions Trial interventions were not considered in this analysis.Measurements and Main Results Oxylipin profiling was performed on 404 serum samples from 152 patients using liquid chromatography-mass spectrometry. Non-survivors were found to have higher levels of 14,15-dihydroxyeicosatrienoic acid at baseline (DHET) than survivors (p=0.02). Patients with 14,15-DHET levels above the lower limit of quantification of the assay were more likely to die than patients with levels below this limit (Hazard Ratio 2.3, 95% CI 1.2-4.5). Patients with measurable 14,15-DHET had higher levels of organ dysfunction and fewer renal failure free days than those in whom it was unmeasurable. Considering samples collected over the first week of intensive care stay, measurable levels of DHET species were associated with higher daily SOFA scores which appeared to be accounted for predominantly by the liver component. Measurable 14,15-DHET showed positive correlation with bilirubin (rs=0.38, p<0.001) and lactate (rs=0.27, p=0.001).Conclusions The P450 epoxygenase-derived DHET species of oxylipins were associated with organ, particularly liver, dysfunction in septic shock and 14,15-DHET was associated with septic shock mortality. These results support further investigation into the role of the P450 epoxygena

Journal article

Munro APS, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Gokani K, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Murira J, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Salkeld J, Saralaya D, Sharma S, Sheridan R, Sturdy A, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN, COV-BOOST study groupet al., 2021, Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial, The Lancet, Vol: 398, ISSN: 0140-6736

BACKGROUND: Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT). METHODS: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY) control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130. FINDINGS: Between June 1 and June

Journal article

Tanha K, Mottaghi A, Nojomi M, Moradi M, Rajabzadeh R, Lotfi S, Janani Let al., 2021, Investigation on factors associated with ovarian cancer: an umbrella review of systematic review and meta-analyses, JOURNAL OF OVARIAN RESEARCH, Vol: 14

Journal article

Rajabzadeh R, Janani L, Motevalian SA, 2021, Effects of different invitation strategies on participation in a cohort study of Iranian public sector employees: a cluster randomized trial, BMC MEDICAL RESEARCH METHODOLOGY, Vol: 21

Journal article

Raji Lahiji M, Najafi S, Janani L, Yazdani B, Razmpoosh E, Zarrati Met al., 2021, The effect of synbiotic on glycemic profile and sex hormones in overweight and obese breast cancer survivors following a weight-loss diet: A randomized, triple-blind, controlled trial, Clinical Nutrition, Vol: 40, Pages: 394-403, ISSN: 0261-5614

Journal article

Mohammady M, Radmehr M, Janani L, 2021, Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity, COCHRANE DATABASE OF SYSTEMATIC REVIEWS, ISSN: 1469-493X

Journal article

Matloubi M, Ranjbar M, Assarehzadegan M-A, Fallahpour M, Sadeghi F, Soleyman-Jahi S, Janani Let al., 2020, The Impact of Interleukin (IL)-33 Gene Polymorphisms and Environmental Factors on Risk of Asthma in the Iranian Population, Lung, Vol: 198, Pages: 105-112, ISSN: 0341-2040

Journal article

Vafaei S, Fattahi F, Ebrahimi M, Janani L, Shariftabrizi A, Madjd Zet al., 2019, &lt;p&gt;Common molecular markers between circulating tumor cells and blood exosomes in colorectal cancer: a systematic and analytical review&lt;/p&gt;, Cancer Management and Research, Vol: Volume 11, Pages: 8669-8698

Journal article

Mohammady M, Janani L, Jahanfar S, Mousavi MSet al., 2018, Effect of omega-3 supplements on vasomotor symptoms in menopausal women: A systematic review and meta-analysis, European Journal of Obstetrics &amp; Gynecology and Reproductive Biology, Vol: 228, Pages: 295-302, ISSN: 0301-2115

Journal article

Janani L, Mansournia MA, Mohammad K, Mahmoodi M, Mehrabani K, Nourijelyani Ket al., 2017, Comparison between Bayesian approach and frequentist methods for estimating relative risk in randomized controlled trials: a simulation study, Journal of Statistical Computation and Simulation, Vol: 87, Pages: 640-651, ISSN: 0094-9655

Journal article

Rezvan N, Moini A, Janani L, Mohammad K, Saedisomeolia A, Nourbakhsh M, Gorgani-Firuzjaee S, Mazaherioun M, Hosseinzadeh-Attar Met al., 2016, Effects of Quercetin on Adiponectin-Mediated Insulin Sensitivity in Polycystic Ovary Syndrome: A Randomized Placebo-Controlled Double-Blind Clinical Trial, Hormone and Metabolic Research, Vol: 49, Pages: 115-121, ISSN: 0018-5043

Journal article

Jalili M, Hekmatdoost A, Vahedi H, Poustchi H, Khademi B, Saadi M, Zemestani M, Janani Let al., 2016, Co-Administration of Soy Isoflavones and Vitamin D in Management of Irritable Bowel Disease, PLOS ONE, Vol: 11, Pages: e0158545-e0158545

Journal article

Mohammady M, Heidari K, Akbari Sari A, Zolfaghari M, Janani Let al., 2014, Early ambulation after diagnostic transfemoral catheterisation: A systematic review and meta-analysis, International Journal of Nursing Studies, Vol: 51, Pages: 39-50, ISSN: 0020-7489

Journal article

Rezvan N, Hosseinzadeh-Attar MJ, Masoudkabir F, Moini A, Janani L, Mazaherioun Met al., 2012, Serum visfatin concentrations in gestational diabetes mellitus and normal pregnancy, Archives of Gynecology and Obstetrics, Vol: 285, Pages: 1257-1262, ISSN: 0932-0067

Journal article

Ahmadi B, Alimohammadian M, Golestan B, Mahjubi B, Janani L, Mirzaei Ret al., 2010, The hidden epidemic of urinary incontinence in women: a population-based study with emphasis on preventive strategies, International Urogynecology Journal, Vol: 21, Pages: 453-459, ISSN: 0937-3462

Journal article

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