ABSTRACT
Background: Primary SARS-CoV-2 vaccination has been shown to wane with time and provide lower protection from disease with new viral variants, prompting the WHO to recommend the administration of booster doses. We determined the safety and immunogenicity of homologous or heterologous boosters with ChAdOx1 nCoV-19 (COVISHIELD™) or BBV152 (COVAXIN®), the two vaccines used widely for primary immunization in India, in participants who had already received two primary doses of these vaccines. Methods: Participants primed with two doses each of COVISHIELD™ or COVAXIN® 12-36 weeks previously, were randomised to receive either COVISHIELD™ or COVAXIN® booster in a 1:1 ratio. The primary outcome was day 28 post-booster anti-spike IgG seropositivity and secondary outcomes were anti-spike IgG levels and assessment of safety and reactogenicity. The results of 90 days intention-to-treat analysis are presented. This trial is registered with ISRCTN (CTRI/2021/08/035648). Findings: In the COVISHIELD™ primed group with 200 participants, the seropositivity 28 days post booster in the heterologous COVAXIN® arm was 99% and non-inferior to the homologous COVISHIELD™ arm, which was also 99% (difference 0%; 95% CI: -2.8% to 2.7%). The geometric mean concentration (GMC) of anti-spike antibodies following heterologous COVAXIN® boost on day 28 was 36,190.78 AU/mL (95% CI: 30,526.64-42,905.88) while the GMC following homologous COVISHIELD™ boost was 97,445.09 AU/mL (82,626.97-114,920.7). In the COVAXIN® primed group with 204 participants, the seropositivity 28 days post booster in the heterologous COVISHIELD™ arm was 100% and non inferior to the homologous COVAXIN® arm which was 96% (difference 4%, 95% CI: 0.2%-7.8%). The GMC following heterologous COVISHIELD™ boost was 241,681.6 AU/mL (95% CI: 201,380.2-290,048.3) compared to homologous COVAXIN® boost, which was 48,473.94 AU/mL (95% CI: 38,529.56-60,984.95). The day 28 geometric mean ratio (GMR) of the anti-spike IgG between the heterologous and homologous boosted arms was 0.42 (95% CI: 0.34-0.52) in the COVISHIELD™ primed group and 5.11 (95% CI: 3.83-6.81) in the COVAXIN® primed group. There were no related serious adverse events reported in any group. Interpretation: Homologous and heterologous boosting with COVISHIELD™ or COVAXIN® in COVISHIELD™ or COVAXIN® primed individuals are immunogenic and safe. A heterologous boost with COVISHIELD™ after COVAXIN® prime offers the best immune response among the four combinations evaluated. Funding: Azim Premji Foundation and Bill and Melinda Gates Foundation.
ABSTRACT
CONTEXT: People living with HIV (PLHIV)/AIDS are faced with the task of maintaining optimal health status despite an increasing insult to their immune status. Antiretroviral therapy (ART) centers provide comprehensive services to all PLHIV enrolled under the program. Patients with higher satisfaction levels may also have improved health outcomes. AIM: The aim of this study was to assess the client's satisfaction on ART service delivery and to identify the factors associated with client's satisfaction. SETTINGS AND DESIGN: This was a facility-based, cross-sectional study. MATERIALS AND METHODS: The study was conducted from August to October 2018 at the ART center of Rajamahendravaram. A total of 485 HIV-positive clients above the age of 15 years on ART for >6 months were selected by systematic random sampling after taking informed verbal consent. Data were collected by interviewing with the help of a validated structured English-version Likert-scale questionnaire, that is, University of Gondar College of Medicine and Health Sciences Institute of Public Health Pro forma. STATISTICAL ANALYSIS USED: Binary logistic regression and Chi-square test were conducted to identify the association between the explanatory variables and outcome variables (patient satisfaction). RESULTS: The mean age of the clients was 39.6 ± 9.9 years. The overall satisfaction rate among the clients was 92.6%. Age, marital status, education, family income, socioeconomic status, and the waiting period to see the doctor were statistically significantly associated with the level of satisfaction of the clients (P < 0.05). CONCLUSION: The present study shows high levels (92.6%) of client satisfaction with services provided at the ART center, Rajamahendravaram. This motivates the health-care workers, program planners, and policymakers for a better continuum of care.
