Humoral immune response following prime and boost BNT162b2 vaccination in people living with HIV on antiretroviral therapy

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Abstract

Objectives

People living with HIV (PLWH) with low CD4 T‐cell counts may be at a higher risk for severe coronavirus disease 2019 (COVID‐19) outcomes and in need of efficient vaccination. The World Health Organization (WHO) now recommends prioritizing PLHIV for COVID‐19 vaccination. Data on immune responses after messenger RNA (mRNA) vaccination in PLHIV in relation to CD4 counts are scarce. We aimed at assessing the humoral immune response in PLHIV after mRNA vaccination against COVID‐19.

Methods

We examined a cohort of PLHIV after prime ( n = 88) and boost ( n = 52) vaccination with BNT162b2. We assessed levels of anti‐severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) spike (S) protein‐specific immunoglobulin G (IgG)/IgA and circulating neutralizing antibodies in plasma and correlated results to the cellular immune status. BNT162b2‐vaccinated health care workers served as controls.

Results

All PLWH had a viral load of ≤ 200 HIV‐1 RNA copies/mL and 96.5% had a viral load of < 50 copies/mL. Anti‐S IgG and neutralizing antibody responses after BNT162b2 priming were significantly lower in PLHIV having a CD4:CD8 T‐cell ratio of < 0.5. However, we observed robust humoral immunity in the majority of PLWH receiving antiretroviral therapy (ART) irrespective of CD4 T‐cell nadir, current CD4 count or CD4:CD8 ratio after full BNT162b2 vaccination. Nevertheless, HIV‐negative controls produced significantly higher mean anti‐S IgG concentrations with less variability.

Conclusions

The majority of PLWH mounted robust responses after complete BNT162b2 vaccination but overall amounts of antibodies directed against the SARS‐CoV‐2 receptor‐binding domain were variable. The impact on clinical efficacy remains unclear.

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Most cited references 17

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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OpenSAFELY: factors associated with COVID-19 death in 17 million patients

Elizabeth J Williamson, Alex J Walker, Krishnan Bhaskaran … (2020)

COVID-19 has rapidly impacted on mortality worldwide. 1 There is unprecedented urgency to understand who is most at risk of severe outcomes, requiring new approaches for timely analysis of large datasets. Working on behalf of NHS England we created OpenSAFELY: a secure health analytics platform covering 40% of all patients in England, holding patient data within the existing data centre of a major primary care electronic health records vendor. Primary care records of 17,278,392 adults were pseudonymously linked to 10,926 COVID-19 related deaths. COVID-19 related death was associated with: being male (hazard ratio 1.59, 95%CI 1.53-1.65); older age and deprivation (both with a strong gradient); diabetes; severe asthma; and various other medical conditions. Compared to people with white ethnicity, black and South Asian people were at higher risk even after adjustment for other factors (HR 1.48, 1.29-1.69 and 1.45, 1.32-1.58 respectively). We have quantified a range of clinical risk factors for COVID-19 related death in the largest cohort study conducted by any country to date. OpenSAFELY is rapidly adding further patients’ records; we will update and extend results regularly.

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Comprehensive mapping of immune perturbations associated with severe COVID-19

Leticia Kuri-Cervantes, M. Betina Pampena, Wenzhao Meng … (2020)

Although critical illness has been associated with SARS-CoV-2-induced hyperinflammation, the immune correlates of severe COVID-19 remain unclear. Here, we comprehensively analyzed peripheral blood immune perturbations in 42 SARS-CoV-2 infected and recovered individuals. We identified extensive induction and activation of multiple immune lineages, including T cell activation, oligoclonal plasmablast expansion, and Fc and trafficking receptor modulation on innate lymphocytes and granulocytes, that distinguished severe COVID-19 cases from healthy donors or SARS-CoV-2-recovered or moderate severity patients. We found the neutrophil to lymphocyte ratio to be a prognostic biomarker of disease severity and organ failure. Our findings demonstrate broad innate and adaptive leukocyte perturbations that distinguish dysregulated host responses in severe SARS-CoV-2 infection and warrant therapeutic investigation.

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Author and article information

Contributors

Georg M. N. Behrens:

ORCID: https://orcid.org/0000-0003-3111-621X

behrens.georg@mh-hannover.de

Journal

Journal ID (nlm-ta): HIV Med

Journal ID (iso-abbrev): HIV Med

Journal ID (doi): 10.1111/(ISSN)1468-1293

Journal ID (publisher-id): HIV

Title: HIV Medicine

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 1464-2662

ISSN (Electronic): 1468-1293

Publication date (Electronic): 02 November 2021

Publication date PMC-release: 02 November 2021

Electronic Location Identifier: 10.1111/hiv.13202

Affiliations

[ ¹ ] Department of Gastroenterology, Hepatology and Endocrinology Hannover Medical School Hannover Germany

[ ² ] Department of Rheumatology and Immunology Hannover Medical School Hannover Germany

[ ³ ] German Center for Infection Research (DZIF) Partner Site Hannover‐Braunschweig Braunschweig Germany

[ ⁴ ] Centre for Individualized Infection Medicine (CiiM) Hannover Germany

Author notes

[*] [* ] Correspondence

Dr Georg M. N. Behrens, Department of Rheumatology and Immunology, Hannover Medical School, Carl‐Neuberg‐Straße 1, D ‐ 30625 Hannover, Germany.

Email: behrens.georg@ 123456mh-hannover.de

Author information

Alexandra Dopfer‐Jablonka https://orcid.org/0000-0001-7129-100X

Gema Morillas Ramos https://orcid.org/0000-0002-4835-5172

Georg M. N. Behrens https://orcid.org/0000-0003-3111-621X

Article

Publisher ID: HIV13202

DOI: 10.1111/hiv.13202

PMC ID: 8652991

PubMed ID: 34725907

SO-VID: 292ad189-8c69-485f-b7d4-ca5aa2ff4d01

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

History

Date revision received : 27 September 2021

Date received : 03 August 2021

Date accepted : 18 October 2021

Page count

Figures: 1, Tables: 1, Pages: 6, Words: 7258

Funding

Funded by: European Regional Development Fund , doi 10.13039/501100008530;

Funded by: German Center for Infection Research , doi 10.13039/100009139;

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details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.9 mode:remove_FC converted:08.12.2021

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: coronavirus disease 2019 (covid‐19) vaccination,hiv,humoral immunity

Data availability:

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: coronavirus disease 2019 (covid‐19) vaccination, hiv, humoral immunity

Humoral immune response following prime and boost BNT162b2 vaccination in people living with HIV on antiretroviral therapy

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Abstract

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Novel Coronavirus Disease COVID-19

Most cited references 17

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

OpenSAFELY: factors associated with COVID-19 death in 17 million patients

Comprehensive mapping of immune perturbations associated with severe COVID-19

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