Background BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine (3 µg or 6 µg) formulated with a toll-like receptor 7/8 agonist molecule (IMDG) adsorbed to alum (Algel). We previously reported findings from a doubleblind, multicentre, randomised, controlled phase 1 trial on the safety and immunogenicity of three different formulations of BBV152 (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) and one Algel-only control (no antigen), with the first dose administered on day 0 and the second dose on day 14. The 3 µg and 6 µg with Algel-IMDG formulations were selected for this phase 2 study. Herein, we report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28.Methods We did a double-blind, randomised, multicentre, phase 2 clinical trial to evaluate the immunogenicity and safety of BBV152 in healthy adults and adolescents (aged 12-65 years) at nine hospitals in India. Participants with positive SARS-CoV-2 nucleic acid and serology tests were excluded. Participants were randomly assigned (1:1) to receive either 3 µg with Algel-IMDG or 6 µg with Algel-IMDG. Block randomisation was done by use of an interactive web response system. Participants, investigators, study coordinators, study-related personnel, and the sponsor were masked to treatment group allocation. Two intramuscular doses of vaccine were administered on day 0 and day 28. The primary outcome was SARS-CoV-2 wild-type neutralising antibody titres and seroconversion rates (defined as a post-vaccination titre that was at least four-fold higher than the baseline titre) at 4 weeks after the second dose (day 56), measured by use of the plaque-reduction neutralisation test (PRNT 50 ) and the microneutralisation test (MNT 50 ). The primary outcome was assessed in all participants who had received both doses of the vaccine. Cell-mediated responses were a secondary outcome and were assessed by T-helper-1 (Th1)/Th2 profiling at 2 weeks after the second dose (day 42). Safety was assessed in all participants who received at least one dose of the vaccine. In addition, we report immunogenicity results from a follow-up blood draw collected from phase 1 trial participants at 3 months after they received the second dose (day 104). This trial is registered at ClinicalTrials.gov, NCT04471519. FindingsBetween Sept 5 and 12, 2020, 921 participants were screened, of whom 380 were enrolled and randomly assigned to the 3 µg with Algel-IMDG group (n=190) or 6 µg with Algel-IMDG group (n=190). Geometric mean titres (GMTs; PRNT 50 ) at day 56 were significantly higher in the 6 µg with Algel-IMDG group (197•0 [95% CI 155•6-249•4]) than the 3 µg with Algel-IMDG group (100•9 [74•1-137•4]; p=0•0041). Seroconversion based on PRNT 50 at day 56 was reported in 171 (92•9% [95% CI 88•2-96•2] of 184 participants in the 3 µg with Algel-IMDG group and 174 (98•3% [95•1-99•6]) of 177 participants in the 6 µg with Algel-IMDG group. GMTs (MNT 50 ) at day 56 were 92•5 (95% CI 77•7-11...
Several experiments, related to controlled thermonuclear fusion research and highly relevant for large size tokamaks, including ITER, have been carried out in ADITYA, an ohmically heated circular limiter tokamak. Repeatable plasma discharges of a maximum plasma current of ~160 kA and discharge duration beyond ~250 ms with a plasma current flattop duration of ~140 ms have been obtained for the first time in ADITYA. The reproducibility of the discharge reproducibility has been improved considerably with lithium wall conditioning, and improved plasma discharges are obtained by precisely controlling the position of the plasma. In these discharges, chord-averaged electron density ~3.0–4.0 × 1019 m−3 using multiple hydrogen gas puffs, with a temperature of the order of ~500–700 eV, have been achieved. Novel experiments related to disruption control are carried out and disruptions, induced by hydrogen gas puffing, are successfully mitigated using the biased electrode and ion cyclotron resonance pulse techniques. Runaway electrons are successfully mitigated by applying a short local vertical field (LVF) pulse. A thorough disruption database has been generated by identifying the different categories of disruption. Detailed analysis of several hundred disrupted discharges showed that the current quench time is inversely proportional to the q edge. Apart from this, for volt–sec recovery during the plasma formation phase, low loop voltage start-up and current ramp-up experiments have been carried out using electron cyclotron resonance heating (ECRH). Successful recovery of volt–sec leads to the achievement of longer plasma discharge durations. In addition, the neon gas puff assisted radiative improved confinement mode has also been achieved in ADITYA. All of the above mentioned experiments will be discussed in this paper.
First indigenously built tokamak ADITYA, operated over 2 decades with circular poloidal limiter has been upgraded to a tokamak named ADITYA Upgrade for the purpose having shape plasma operation with open divertor geometry. Experiment research in ADITYA-U has made significant progress, since last FEC 2016. After installation of PFC and standard tokamak diagnostics, the Phase-I plasma operations were conducted from December 2016 with graphite toroidal belt limiter. Purely Ohmic discharges in circular plasmas supported by Filament pre-ionization was obtained. The plasma parameters, Ip ~ 80-95 kA, duration ~ 80-180 ms with toroidal field (max.) ~ 1T and chord-averaged electron density ~ 2.5 x 10^19 m^-3 has been achieved. Being a medium sized tokamak, runaway electron (RE) generation, transport and mitigation experiments have always been one of the prime focus of ADITYA-U. MHD activities and density enhancement with H2 gas puffing studied. The Phase-I operation was completed in March 2017. The Phase-II operation preparation in ADITYA-U includes calibration of magnetic diagnostics followed by commissioning of major diagnostics and installation of baking system. After repeated cycles of baking the vacuum vessel up to ~ 130°C, the Phase-II operations resumed from February 2018 and are continuing to achieve plasma parameters close to the design parameters of circular limiter plasmas using real time plasma position control. Hydrogen gas breakdown was observed in more than ~2000 discharge including Phase-I and Phase-II operation without a single failure. Several experiments, including the primary RE control with lower E/P operation and secondary RE control with fuelling of Supersonic Molecular Beam Injection as well as sonic H2 gas puffing during current flat-top and Neon gas puffing for better plasma confinement are undergoing. The dismantling of ADITYA and reassembling of ADITYA-U along with experimental results of Phase-I and Phase-II operations from ADITYA-U will be discussed.
Disruptions, induced in Aditya tokamak by hydrogen gas puffing, are successfully mitigated through stabilization of magnetohydrodynamic (MHD) modes by applying a bias voltage to an electrode placed inside the last-closed flux surface prior to the gas injection. Above a threshold voltage sheared E r × B φ rotation of the plasma generated by the edge biasing leads to substantial reduction in the growth of MHD modes (m/n = 3/1, 2/1), which causes avoidance of disruptions through prevention of mode overlapping and subsequent ergodization of magnetic field lines.
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