key: cord-0805588-1hx0ho7z
authors: Malissen, N.; Ninove, L.; de Lamballerie, Xavier; André, N.; Gaudy-Marqueste, C.
title: Safety and immunogenicity following 2 doses of BNT162b2 COVID-19 vaccine in an early phase oncology trial center population
date: 2021-08-10
journal: Eur J Cancer
DOI: 10.1016/j.ejca.2021.07.040
sha: 795c866ae6a7215af916dc982b012ac3eea99405
doc_id: 805588
cord_uid: 1hx0ho7z

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Since patients with cancers were excluded from COVID-19 vaccine clinical trials, there is concern about efficacy and safety profile of vaccines in this setting. Publications focusing on cancer patients reported weak immunogenicity after a single dose (1) but efficient immunogenicity after two doses of BNT162b2 COVID-19 vaccine (2, 3), as well as lower titers of neutralizing antibodies after 1 dose of vaccine in patients receiving checkpoint inhibitors (4). However, limited data is available for patients enrolled in early phase clinical trials. We thus aimed to assess safety and immunogenicity of vaccine in a cohort of early-phase trial oncology patients.

We retrospectively collected data from patients who received 2 doses of BNT162b2 COVID-19 vaccine, between January 2021 and April 2021. COVID-19 immunization had been monitored, as part of routine care: samples were taken before the first dose (T0), before the second dose (T1) and one month after the second dose of the vaccine (T2) with a 21 to 28 days interval between the doses, as recommended in France. Vaccine was injected in between experimental treatment administrations, except for patients on a continuous regimen. PCR swab tests were performed at each patient's venue to rule out asymptomatic SARS-Cov-2 infections. Serum samples were tested for quantitative detection of anti-SARS-Cov-2 spike (S1) IgG antibodies (Euroimmun®, Luebeck, Germany). In samples with an ELISA ratio ≥0.7, neutralizing antibodies against SARS-Cov-2 were detected using a virus neutralization test (VNT100). Study was approved by the data protection committee of AP-HM.

Out of a total population of 86 patients, 17 (37%) refused vaccination, 48 were vaccinated including 35 in our center from which 22 were studied. Patient's characteristics are detailed in Sup. Material. All had metastatic disease, the most frequent tumor types were lung (43%) and melanoma (38%). Cancer treatment at the time of vaccination consisted of an immunotherapy regimen in 64% (from which 50% were used in combination with an anti-angiogenic therapy), targeted therapy in 27% and chemotherapy for the remaining 9% (Sup. Material). 57% of patients reported G1 adverse events related to vaccination that did not postpone experimental treatment administration. None of the patients was diagnosed with SARS-Cov-2 infection during or after vaccine administration.

Seroconversion rates were 37% at T1 and 77% at T2 (Figure 1 ). Among patients who seroconverted, 2 out of 8 had positive neutralizing antibodies at T1 while 16 out of 20 had positive neutralizing antibodies at T2. We could identify no difference depending on patient's age, treatment type or lymphocytes count.

The 77% seroconversion rate achieved after 2 doses of vaccine in our cohort is in line with the data reported in other oncology patients treated with this vaccine scheme, without unexpected toxicity or treatment delay. This is lower than reported in a small series of adolescents and young adults (5). The lower rate of neutralizing antibodies among seropositive patient might be explained by differences in assays. Conclusion: 2 injections of BNT162b2 COVID-19 vaccine seems efficient and safe in cancer patients in early phase trials.

N.Malissen 1,2,* , L.Ninove 3 , Xavier de Lamballerie 3 , N.André 1,4 , C.Gaudy-Marqueste 1,2

Weak immunogenicity after a single dose of SARS-CoV-2 mRNA vaccine in treated cancer patients

N.M declares having received advisory fees from Bristol-Myers Squibb, payment for lectures and meeting invitations from Novartis, Bristol-Myers Squibb and MSD

André reports receiving grants and drugs for trial from Bristol Myers Squibb; receiving drugs for a trial from Pierre Fabre; receiving drugs and grants for a clinical trial from Bristol Myers Squibb outside the area of work commented on here; receiving travel support from Bristol Myers Squibb for an International Society of Paediatric Oncology meeting; and participating as a scientific advisory board member (without receiving personal fees) for Bayer and Bristol Myers Squibb, Partners Therapeuticsoutside the area of work commented on here C.G-M has received consulting fees from Bristol-Myers Squibb and payment for lectures from Bristol-Myers Squibb and Roche