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Immunogenicity and Safety of the BNT162b2 mRNA COVID-19 Vaccine in People Living with HIV-1

14 Pages Posted: 20 Apr 2021

See all articles by Itzchak Levy

Itzchak Levy

Chaim Sheba Medical Center - Infectious Diseases Unit

Anat Wieder-Finesod

Chaim Sheba Medical Center - Infectious Diseases Unit

Vladyslav Litchevski

Chaim Sheba Medical Center - Infectious Diseases Unit

Asaf Biber

Chaim Sheba Medical Center - Infectious Diseases Unit

victoria Indenbaum

Chaim Sheba Medical Center - Central Virology Laboratory

Liraz Olmer

Bio-statistical and Bio-mathematical Unit, The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center

Amit Huppert

Sheba Medical Center - Central Virology Laboratory; Chaim Sheba Medical Center - Bio-statistical and Bio-mathematical Unit

Orna Mor

Chaim Sheba Medical Center

May Goldstein

Chaim Sheba Medical Center - Infectious Diseases Unit

Einav Sapir

Sackler Faculty of Medicine, Tel-Aviv University

Tammy Hod

Tel-Aviv University - Sackler Faculty of Medicine

Carmit Cohen

Chaim Sheba Medical Center - Infection Prevention & Control Unit

Yaniv Lustig

Chaim Sheba Medical Center - Central Virology Laboratory

Galia Rahav

Chaim Sheba Medical Center - Infectious Diseases Unit

More...

Abstract

Background: The immunogenicity and safety of the Pfizer-BioNTech BNT162b2 mRNA vaccine in people living with HIV-1 (PLWH) are unknown. We thus aimed to assess the immunogenicity and safety of this vaccine in PLWH.

Methods: In this prospective open study, we enrolled 143 PLWH, aged ³18 years, who attended our clinic. Patients who had recovered from COVID-19 were excluded. SARS-CoV-2 receptor binding domain (RBD) IgG and neutralizing antibodies were measured and compared to those in a cohort of vaccinated health care workers (HCWs). Adverse events, viral load and CD4 cell counts were monitored.

Findings:  At a median of 15 (IQR 14-19) days following the first dose of the BNT162b2 vaccine and 18 (IQR 14-21) days after the second dose, anti-RBD IgG was positive in 66/128 (51%) and 139/141 (98%) PLWH, respectively. Among the HCWs, 235/399 (59%) and 269/272 (99%) developed anti-RBD IgG at a median of 14 (IQR 14-14) and 26 (IQR 24-27) days after first and second doses, respectively. Following the second dose, immune sera neutralized SARS-CoV-2 pseudo-virus (psSARS-2) in 97% and 98% of PLWH and HCW, respectively. Vaccination was associated with adverse events in 60% of PLWH, mainly pain at the injection site, fatigue, and headache. AIDS-related adverse events were not reported.  HIV viral load increased in 3/143 (2%) patients from < 40 copies/mL to ≤ 100 copies/mL. CD4+ T cell count decreased from a geometric mean of 700 (95% CI 648–757) cells/mm3 to 633.8 (95% CI 588–683) cells/mm 3 (P<0.01).

Interpretation: This study on BNT162b2 vaccination in PLWH revealed a high antibody response without detrimental effect on viral load. A small decline in CD4 cell count was noted, but it was not accompanied by clinical deterioration. This study thus provides support for the immunization of PLWH against COVID-19 with the BNT162b2 mRNA Covid-19 vaccine.

Funding Statement: None.

Declaration of Interests: None.

Ethics Approval Statement: Written informed consent was obtained from all participants and the study protocol and informed consent were approved by the Institutional review board of Sheba Medical Center.

Suggested Citation

Levy, Itzchak and Wieder-Finesod, Anat and Litchevski, Vladyslav and Biber, Asaf and Indenbaum, victoria and Olmer, Liraz and Huppert, Amit and Mor, Orna and Goldstein, May and Sapir, Einav and Hod, Tammy and Cohen, Carmit and Lustig, Yaniv and Rahav, Galia, Immunogenicity and Safety of the BNT162b2 mRNA COVID-19 Vaccine in People Living with HIV-1. Available at SSRN: https://ssrn.com/abstract=3829650 or http://dx.doi.org/10.2139/ssrn.3829650

Itzchak Levy (Contact Author)

Chaim Sheba Medical Center - Infectious Diseases Unit ( email )

Tel-Hashomer
Israel

Anat Wieder-Finesod

Chaim Sheba Medical Center - Infectious Diseases Unit ( email )

Tel-Hashomer
Israel

Vladyslav Litchevski

Chaim Sheba Medical Center - Infectious Diseases Unit ( email )

Tel-Hashomer
Israel

Asaf Biber

Chaim Sheba Medical Center - Infectious Diseases Unit ( email )

Tel-Hashomer
Israel

Victoria Indenbaum

Chaim Sheba Medical Center - Central Virology Laboratory ( email )

Ramat-Gan
Israel

Liraz Olmer

Bio-statistical and Bio-mathematical Unit, The Gertner Institute of Epidemiology and Health Policy Research, Sheba Medical Center ( email )

Tel Hashomer
Ramat-Gan
Israel

Amit Huppert

Sheba Medical Center - Central Virology Laboratory ( email )

Ramat-Gan
Israel

Chaim Sheba Medical Center - Bio-statistical and Bio-mathematical Unit ( email )

Tel Hashomer
Ramat-Gan
Israel

Orna Mor

Chaim Sheba Medical Center

Tel Hashomer
Ramat-Gan
Israel

May Goldstein

Chaim Sheba Medical Center - Infectious Diseases Unit ( email )

Tel-Hashomer
Israel

Einav Sapir

Sackler Faculty of Medicine, Tel-Aviv University ( email )

Tel-Aviv
Israel

Tammy Hod

Tel-Aviv University - Sackler Faculty of Medicine ( email )

Tel-Aviv
Israel

Carmit Cohen

Chaim Sheba Medical Center - Infection Prevention & Control Unit ( email )

Tel Hashomer
Ramat-Gan
Israel

Yaniv Lustig

Chaim Sheba Medical Center - Central Virology Laboratory ( email )

Ramat-Gan
Israel

Galia Rahav

Chaim Sheba Medical Center - Infectious Diseases Unit ( email )

Tel-Hashomer
Israel

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