Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 and BNT162b2 Vaccines in People With HIV

Manuel González de Aledo; Angelina Cañizares; Pilar Vázquez-Rodríguez; Ángeles Castro; Luz Moldes; Soledad López; Enrique Míguez; Germán Bou; Álvaro Mena

Disclosures

AIDS. 2022;36(5):691-695. 

In This Article

Abstract and Introduction

Abstract

Objective: To evaluate the safety and the serological response after two doses of mRNA-based SARS-CoV-2 vaccination in people with HIV (PWH).

Methods: Participants were evaluated 4 weeks after the second dose of mRNA-1273 or BNT162b2 vaccine. Tolerability was evaluated with a specific adverse event questionnaire. Patient's sera were analysed using LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin).

Results: One-hundred PWH were included, 75% of them men, with a mean age of 44 ± 11 years old, all receiving antiretroviral treatment and mostly with controlled viral loads (98% with HIV RNA <50 copies/ml) and 96% had >200 CD4+/μl. All patients seroconverted after vaccination (antibody concentration ≥33.8 binding antibody units [BAU]/ml). Only 3% of the patients had a low antibody concentration (<520 BAU/ml), whereas 67% of them had concentrations above the assay's detection range (>2080 BAU/ml). Fifty-six patients had local or systemic symptoms, with mild arthromyalgia being the most common systemic symptom. No severe adverse events were reported.

Conclusions: Vaccination with two doses of mRNA-1273 or BNT162b2 is well tolerated in PWH under effective antiretroviral treatment and it leads to a successful antibody response.

Introduction

The impact of the coronavirus disease 2019 (COVID-19) pandemic is unquestionable. Several studies that analysed the severity of COVID-19 in people with HIV (PWH) concluded that although PWH under effective antiretroviral treatment (ART) had comparable or even milder infections and severity than HIV-uninfected persons, more severe episodes were documented in PWH with poor HIV-infection control.[1,2] In addition, the antibody response in PWH under ART convalescing from COVID-19 is comparable to that of HIV-uninfected individuals.[3]

The rapid development of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines has been an unprecedented success. A vaccination programme using the BNT162b2 vaccine started across Europe on 27 December 2020. After months of intensive vaccination, its impact on the COVID-19 pandemic has been remarkable. Vaccines have been responsible for a significant drop in the number of deaths and hospitalizations associated with COVID-19, as observed in Israel[4,5] and the UK,[6] supporting their clinical efficacy.

Historically, the serological response to vaccines in PWH is usually worse than that in the general population.[7] PWH were under-represented in clinical trials of SARS-CoV-2 mRNA vaccines: just 176 and 196 PWH volunteers were included in phase III clinical trials of mRNA-1273 and BNT162b2 vaccines, respectively. There is a paucity of data analysing the response to these vaccines in PWH.[8,9] The aim of this study was to analyse the safety and antibody response to mRNA-based COVID-19 vaccines in PWH.

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