ABSTRACT
Several studies have shown that subjects with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection had significantly higher antibody titers than previously uninfected vaccinees after vaccination with mRNA vaccine. Yet no information is available for other vaccines. In the current observational cohort study, 105 health care workers who had received Covishield an Adeno associated viral vector-based DNA vaccine were enrolled at Sarojini Nadu Medical College Agra, India. The study included 40 (23 men and 17 women) subjects with a previous history of SARS-CoV-2 infection and 65 participants (39 men and 26 women) who were not infected previously. Both the groups received the adenovirus vector vaccine ChAdOx1-S recombinant vaccines (Covishield, Astra Zeneca). The levels of SARS-CoV-2-anti-spike-IgG-antibodies titer were measured using Electrochemiluminescence immunoassay on Roche platform as arbitrary units per milliliter (AU/ml). After 28 days of the second dose, subjects with no previous SARSCoV-2 infection showed a significantly lower level of circulating anti-spike-IgG-antibody titers compared to previously infected participants. After the second dose, we also observed a significant increase in SARS-CoV-2 infection in subjects with no prior history of SARS-CoV-2 infection compared to subjects with a previous history of natural infection. The most important observation of the study is a low percentage of infection in previously infected subjects. The finding of the study also indicates the presence of robust humoral memory response in previously infected patients.
ABSTRACT
ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial. SettingThirty-nine public and private hospitals across India. ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 [≤] 93% on room air). InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment. ResultsBetween 22nd April to 14th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19. Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.