Sputnik V Protection from COVID-19 of HIV-Infected Individuals Under Art

Autor: R. R. Adgamov, Alexey G. Kolotii, Alexey Mazus, Roman D. Zaitsev, Vladimir A. Gushchin, Dmitry V. Shcheblyakov, Aleksandra S. Zhilenkova, Alexander L. Gintsburg, Nataliia V. Glukhoedova, Denis Y. Logunov, Elena V. Tsyganova, Darya A. Ogarkova
Rok vydání: 2021
Předmět:
Zdroj: SSRN Electronic Journal.
ISSN: 1556-5068
Popis: Background: HIV infection is a known factor that aggravates the clinical course of many infectious diseases including COVID-19. The international guidance suggests that benefits from preventive SARS-CoV-2 vaccination using products with proven efficacy overweigh potential risks for HIV-infected people. However, there is little data on epidemiological assessment of COVID-19 vaccines efficacy among HIV-infected people. This paper provides preliminary assessment of Sputnik V (Gam-COVID-Vac) vaccine effectiveness in HIV-infected patients under antiretroviral therapy (ART) in Moscow. Methods: We performed a retrospective cohort study to assess the effectiveness of Sputnik V standard vaccination regimen in HIV-infected patients during spring-summer 2021, comparing SARS-CoV-2 PCR-positivity, hospitalization, and severe illness rates in vaccinated and unvaccinated subjects. The study included HIV-positive subjects on ART from Moscow City Center for AIDS Prevention and Control, using data from the Moscow COVID-19 Vaccination and COVID-19 incidence Registries. Vaccine effectiveness was calculated as (1-RR)*100%, where RR – is a risk ratio to contract SARS-CoV-2 in both unvaccinated and vaccinated individuals. 2021 spring data shows Sputnik V effectiveness against initial SARS-CoV-2 variant, while summer data are indicative of vaccine effectiveness against the Delta and its descendant lines. Results: The data obtained indicate that Sputnik V epidemiological effectiveness in the entire cohort of HIV-infected people on ART in Moscow was 76·33% (95% CI 69·84% – 81·43%). In the subgroup of HIV-infected patients with CD4+ T-cell count ≥ 350 cells/μl vaccine effectiveness was 79·42% (95% CI 72·54 – 84·57), preventing hospital admissions in 90·12% (95% CI 77·70 – 95·62) and protecting from the development of moderate-to-severe and severe disease in 97·06% (95% CI 78·93 – 99·59). During predominant circulation of the delta variant Sputnik V epidemiological effectiveness in subjects with CD4+ T-cells count ≥ 350 cells/μl was 65·35% (52·61% – 74·66%), preventing hospital admissions in 75·77% (95% CI 44·25 – 89·47) and protecting from the development of moderate-to-severe and severe disease in 93·05% (95% CI 49·51 – 99·04). Conclusion: The study demonstrated high epidemiological effectiveness of full immunization with Sputnik V in HIV-infected ART-treated patients with CD4 + T-cell counts ≥ 350 cells/μl. Moreover, the epidemiological effectiveness of vaccination was documented for both – the original and the delta SARS-CoV-2 variants, with the latter predominating in the Moscow region since June 2021. Although the efficiency of the vaccine declined in immunocompromised individuals (T-cell count < 350 cells/μl), it is still sufficient to recommend vaccination with Sputnik V of this cohort. Funding: Ministry of Health of Russia and Moscow Healthcare Department. Declaration of Interest: DVS, DYL and ALG report patents for a Sputnik V immunobiological expression vector, pharmaceutical agent, and its method of use to prevent COVID-19. All other authors declare no competing interests. Ethics Approval Statement: All information from the databases was anonymized before it was received by the research team. The study was submitted to the Local Ethics Committee of State Budgetary Healthcare Institution Infectious Diseases Hospital № 2 Moscow Health Department. The Committee concluded (Protocol № 11 of 04/10/2021) that the study does not use identifiable biological specimens and does not provide any confidential patient data. Therefore, according to the rules of the Local Ethics Committee and National standards, this project does not require ethical approval.
Databáze: OpenAIRE
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