scholarly journals The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old

2020 ◽  
Vol 22 ◽  
pp. 02001
Author(s):  
O.P. Kovtun ◽  
V.V. Romanenko ◽  
I.V. Feldblum ◽  
A.U. Sabitov ◽  
A.V. Ankudinova
Keyword(s):  
Influenza Vaccine ◽  
Pediatric Population ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Age Groups ◽  
Quadrivalent Vaccine ◽  
Seroprotection Rate ◽  
Double Blind ◽  
Care Workers ◽  
B Virus

Russian health care workers currently use trivalent influenza vaccines with a strain of a single lineage of type B virus. The purpose of our study was to evaluate the immunogenicity of an adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old. We compared this new vaccine to a trivalent Grippol Plus vaccine in terms of immunogenicity against certain strains of influenza virus. A multicenter double-blind randomized controlled clinical study was conducted in 440 pediatric subjects (age groups: 6 to 11; 12 to 17 y.o.); 221 subjects received Grippol Quadrivalent, 219 – Grippol Plus. Vaccine immunogenicity was evaluated by seroprotection rate (SPR), seroconversion rate (SCR), geometric mean titer (GMT) of antibodies, and an X-fold rise in antibodies level (↑GMT). Antibodies quantification was done using hemagglutination inhibition assay (HAI) in serial serum dilutions. No significant differences were found between the two vaccines’ performance against A(H1N1), A(H3N2) strains or Victoria B virus. With respect to type A virus, both vaccines satisfied three of CPMP criteria (SPR, SCR, ↑GMT). With respect to Victoria B virus, the two vaccines met but one CPMP criterion (↑GMT). The immunogenicity against Yamagata B virus was evaluated only for Grippol Quadrivalent vaccine which met two of CPMP requirements (SCR, ↑GMT). Our findings suggest that in terms of its prophylactic efficiency, Grippol Quadrivalent vaccine is no inferior to the Grippol Plus one.

Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults

2020 ◽  
Author(s):  
Jerald Sadoff ◽  
Els De Paepe ◽  
Wouter Haazen ◽  
Edmund Omoruyi ◽  
Arangassery R Bastian ◽  
...  
Keyword(s):  
Older Adults ◽  
Influenza Vaccine ◽  
Geometric Mean ◽  
Controlled Study ◽  
Tolerability Profile ◽  
Double Blind ◽  
Inhibition Antibody ◽  
Binding Antibody ◽  
Syncytial Virus ◽  
Significant Disease

Abstract Background Respiratory syncytial virus (RSV) and influenza cause significant disease burden in older adults. Overlapping RSV and influenza seasonality presents the opportunity to coadminister vaccines for both infections. This study assessed coadministration of the investigational vaccine, Ad26.RSV.preF, an adenovirus serotype 26 (Ad26) vector encoding RSV F protein stabilized in its prefusion conformation (pre-F), with a seasonal influenza vaccine in older adults. Methods In this phase 2a, double-blind, placebo-controlled study, 180 adults aged ≥60 years received Ad26.RSV.preF plus Fluarix on day 1 and placebo on day 29, or placebo plus Fluarix on day 1 and Ad26.RSV.preF on day 29 (control). Results The coadministration regimen had an acceptable tolerability profile. Reactogenicity was generally higher after Ad26.RSV.preF versus Fluarix, but symptoms were generally transient and mild or moderate. At 28 days after the first vaccination, the upper confidence intervals of the hemagglutination inhibition antibody geometric mean ratio (control/coadministration) for all influenza strains were <2, demonstrating noninferiority. Robust neutralizing and binding antibody responses to RSV A2 were observed in both groups. Conclusions Coadministration of Fluarix with Ad26.RSV.preF vaccine had an acceptable safety profile and showed no evidence of interference in immune response. The results are compatible with simultaneous seasonal vaccination with both vaccines. Clinical Trials Registration NCT03339713.

scholarly journals Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

2012 ◽  
Vol 19 (8) ◽  
pp. 1296-1303 ◽  
Author(s):  
Robert W. Frenck ◽  
Alejandra Gurtman ◽  
John Rubino ◽  
William Smith ◽  
Martin van Cleeff ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Group 2 ◽  
Group 1

ABSTRACTA randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50 to 59 years (n= 1,116) received TIV with PCV13 (group 1) or placebo (group 2) (1:1 randomization); 1 month later, group 1 received placebo and group 2 received PCV13. A hemagglutination inhibition (HAI) assay for TIV and a standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG) were performed and opsonophagocytic activity (OPA) titers (assessedpost hoc) were measured at baseline and 1 and 2 months postvaccination. The rises in HAI assay geometric mean titer (GMT) and percentage of participants in groups 1 and 2 with ≥4-fold increases in HAI responses (A/H1N1, 84.0% and 81.2%, respectively; A/H3N2, 71.1% and 69.5%, respectively; and B, 60.6% and 60.3%, respectively) were similar. In group 1, all serotypes met the predefined IgG geometric mean concentration (GMC) ratio noninferiority criterion relative to group 2, but GMCs were lower in group 1 than group 2. When comparing group 1 with group 2, 5 serotypes did not meet the OPA GMT ratio noninferiority criterion, and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in group 1 (86.2%) than group 2 (76.7%;P< 0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.

Glucocorticoid: Major Factor for Reduced Immunogenicity of 2009 Influenza A (H1N1) Vaccine in Patients with Juvenile Autoimmune Rheumatic Disease

2011 ◽  
Vol 39 (1) ◽  
pp. 167-173 ◽  
Author(s):  
NADIA E. AIKAWA ◽  
LUCIA M.A. CAMPOS ◽  
CLOVIS A. SILVA ◽  
JOZELIO F. CARVALHO ◽  
CARLA G.S. SAAD ◽  
...  
Keyword(s):  
Rheumatic Disease ◽  
Influenza A ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Healthy Controls ◽  
Seroprotection Rate ◽  
H1n1 Vaccine ◽  
Link Type ◽  
Autoimmune Rheumatic Disease ◽  
Influenza A H1n1

Objective.To assess the immunogenicity and safety of non-adjuvanted influenza A H1N1/2009 vaccine in patients with juvenile autoimmune rheumatic disease (ARD) and healthy controls, because data are limited to the adult rheumatologic population.Methods.A total of 237 patients with juvenile ARD [juvenile systemic lupus erythematosus (JSLE), juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), juvenile scleroderma, and vasculitis] and 91 healthy controls were vaccinated. Serology for anti-H1N1 was performed by hemagglutination inhibition assay. Seroprotection rate, seroconversion rate, and factor-increase in geometric mean titer (GMT) were calculated. Adverse events were evaluated.Results.Age was comparable in patients and controls (14.8 ± 3.0 vs 14.6 ± 3.7 years, respectively; p = 0.47). Three weeks after immunization, seroprotection rate (81.4% vs 95.6%; p = 0.0007), seroconversion rate (74.3 vs 95.6%; p < 0.0001), and the factor-increase in GMT (12.9 vs 20.3; p = 0.012) were significantly lower in patients with juvenile ARD versus controls. Subgroup analysis revealed reduced seroconversion rates in JSLE (p < 0.0001), JIA (p = 0.008), JDM (p = 0.025), and vasculitis (p = 0.017). Seroprotection (p < 0.0001) and GMT (p < 0.0001) were decreased only in JSLE. Glucocorticoid use and lymphopenia were associated with lower seroconversion rates (60.4 vs 82.9%; p = 0.0001; and 55.6 vs 77.2%; p = 0.012). Multivariate logistic regression including diseases, lymphopenia, glucocorticoid, and immunosuppressants demonstrated that only glucocorticoid use (p = 0.012) remained significant.Conclusion.This is the largest study to demonstrate a reduced but adequate immune response to H1N1 vaccine in patients with juvenile ARD. It identified current glucocorticoid use as the major factor for decreased antibody production. The short-term safety results support its routine recommendation for patients with juvenile ARD. ClinicalTrials.gov; NCT01151644.

Detection of respiratory and enteric shedding of bovine coronaviruses in cattle in Northwestern Turkey

2005 ◽  
Vol 53 (1) ◽  
pp. 137-146 ◽  
Author(s):  
M. Hasoksuz ◽  
A. Kayar ◽  
T. Dodurka ◽  
A. Ilgaz
Keyword(s):  
Seroconversion Rate ◽  
Geometric Mean ◽  
Age Groups ◽  
Clinical Signs ◽  
Feedlot Cattle ◽  
Antibody Detection ◽  
Age Group ◽  
Adult Cattle ◽  
Northwestern Turkey ◽  
Significant Difference

Bovine coronavirus (BCoV) is an important cause of diarrhoea in calves, winter dysentery in adult cattle and respiratory tract disease in feedlot cattle. Serum, faecal and nasal swab samples were collected from a total of 96 cattle with clinical signs in 29 barns of 23 villages in Northwestern Turkey. The cattle were subdivided into 3 distinct age groups (0-30 days old, 4-12 months old and 2-7 years old). An indirect antigen-capture ELISA and an antibody-detection ELISA as well as geometric mean BCoV antibody titres were used to detect BoCV shed in the faeces and in the nasal secretions, respectively. Relationships between BCoV shedding and age group, seroconversion and clinical signs in cattle were also analysed. The rate of faecal shedding of BoCV was 37.1% (13/35) in 0-30 days old calves, 25.6% (10/39) in 4-12 months old feedlot cattle and 18.2% (4/22) in 2-7 years old cows. The overall rate of BCoV faecal shedding was 28.1% (27/96) in the cattle examined. Only one animal in the 4-12 months old age group was found to shed BoCV nasally. The analysis showed that there was a significant difference (P < 0.0001) with respect to faecal shedding between the clinical signs and the age groups. BCoV antibody titre in 50% of all cattle was ≤ 100 as detected by ELISA while 27.1% of the cattle had high titres ranging between 1,600 and 25,600. The seroconversion rate was 7.3% (7/96) in animals shedding BoCV in the faeces and 42.7% (41/96) in cattle negative for faecal shedding as detected by ELISA, and 20.8% of cattle with no seroconversion shed BCoV in the faeces. There was no statistically significant association between seroconversion and nasal or faecal BCoV shedding. These findings confirm the presence of BCoV infections in Turkey. Further studies are needed to isolate BCoV strains in Turkey and to investigate their antigenic and genetic properties.

scholarly journals Quadrivalent Influenza Vaccine-Induced Antibody Response and Influencing Determinants in Patients ≥ 55 Years of Age in the 2018/2019 Season

2019 ◽  
Vol 16 (22) ◽  
pp. 4489 ◽  
Author(s):  
Maria Ganczak ◽  
Paulina Dubiel ◽  
Marzena Drozd-Dąbrowska ◽  
Ewelina Hallmann-Szelińska ◽  
Karol Szymański ◽  
...  
Keyword(s):  
Antibody Response ◽  
Influenza Vaccine ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Primary Care Clinic ◽  
Influenza B ◽  
Serum Samples ◽  
Care Clinic ◽  
B Lineage ◽  
Quadrivalent Influenza Vaccine

The effects of immunization with subunit inactivated quadrivalent influenza vaccine (QIV) are not generally well assessed in the elderly Polish population. Therefore, this study evaluated vaccine-induced antibody response and its determinants. Methods: Consecutive patients ≥ 55 years old, attending a Primary Care Clinic in Gryfino, Poland, received QIV (A/Michigan/ 45/2015(H1N1)pdm09, A/Singapore/INFIMH-16-0019/2016 (H3N2), B/Colorado/06/2017, B/Phuket/ 3073/2013) between October-December 2018. Hemagglutination inhibition assays measured antibody response to vaccine strains from pre/postvaccination serum samples. Geometric mean titer ratio (GMTR), protection rate (PR) and seroconversion rate (SR) were also calculated. Results: For 108 patients (54.6% males, mean age: 66.7 years) the highest GMTR (61.5-fold) was observed for A/H3N2/, then B/Colorado/06/2017 (10.3-fold), A/H1N1/pdm09 (8.4-fold) and B/Phuket/ 3073/2013 (3.0-fold). Most patients had post-vaccination protection for A/H3N2/ and B/Phuket/3073/ 2013 (64.8% and 70.4%, respectively); lower PRs were observed for A/H1N1/pdm09 (41.8%) and B/Colorado/06/ 2017 (57.4%). The SRs for A/H3N2/, A/H1N1/pdm09, B Victoria and B Yamagata were 64.8%, 38.0%, 46.8%, and 48.2%, respectively. Patients who received QIV vaccination in the previous season presented lower (p < 0.001 and p = 0.03, respectively) response to B Victoria and B Yamagata. Conclusions: QIV was immunogenic against the additional B lineage strain (B Victoria) without significantly compromising the immunogenicity of the other three vaccine strains, therefore, adding a second B lineage strain in QIV could broaden protection against influenza B infection in this age group. As the QIV immunogenicity differed regarding the four antigens, formulation adjustments to increase the antigen concentration of the serotypes that have lower immunogenicity could increase effectiveness. Prior season vaccination was associated with lower antibody response to a new vaccine, although not consistent through the vaccine strains.

scholarly journals Short-term immunogenicity of standard and accelerated hepatitis B virus vaccination schedules in healthy adults: a comparative field study in China

2018 ◽  
Vol 38 (5) ◽  
Author(s):  
Xuan Zhang ◽  
Juan Wang ◽  
Xi Chen ◽  
Menglu Yu ◽  
Shuangbin Yu ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Dose Schedule ◽  
Healthy Adults ◽  
World Health ◽  
Standard Group ◽  
Short Term ◽  
B Virus

World Health Organization recommends hepatitis B virus (HBV) immunization at 0, 1, and 6 months. However, studies have suggested that shortening the interval between the first and last HBV immunization can improve completion rates. Less clear is whether accelerated immunization is as immunogenic as standard immunization. Thus, the present study aimed to compare the short-term immunogenicity of yeast-derived hepatitis B vaccine in healthy adults immunized on an accelerated or standard schedule. Between June 2013 and March 2014, individuals from Jinfeng and Longmen, China were randomly assigned to receive the vaccine on an accelerated schedule (at 0, 1, and 2 months; n=201) or a standard schedule (at 0, 1, and 6 months; n=206). Subjects filled out a questionnaire asking about demographic and other health data, and they underwent physical examination. Blood was assayed for HBV surface antigen and HBV surface antibody (HBsAb) at 1–2 months after the three-dose schedule. Multivariate binary logistic regression was used to determine whether the rate of anti-HBs seroconversion differed with immunization schedule. Covariance analysis was used to compare geometric mean HBsAb concentration between the two schedules. The anti-HBs seroconversion rate was 84.6% in the accelerated group and 90.3% in the standard group. After controlling for several potential confounders, the accelerated schedule was associated with significantly lower anti-HBs seroconversion rate (OR: 0.560, 95% CI: 0.318–0.988). Similarly, the accelerated schedule was associated with significantly lower geometric mean HBsAb concentration. These results suggest that the standard schedule is more likely to lead to anti-HBs seroconversion and higher HBsAb levels in adults.

scholarly journals Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults

2020 ◽  
Vol 8 ◽  
pp. 251513552092533
Author(s):  
Goran Stevanovic ◽  
Aleksandar Obradovic ◽  
Snezana Ristic ◽  
Dragan Petrovic ◽  
Branislava Milenkovic ◽  
...  
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Injection Site ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Phase Iii ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Post Vaccination ◽  
Robust Immune Response

This study was a phase III, multicenter, double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity of a seasonal trivalent split, inactivated influenza vaccine (TIV) in healthy Serbian adults between the ages of 18 and 65 years. This egg-based vaccine was manufactured by the Institute of Virology, Vaccines and Sera, Torlak, Belgrade, Serbia. A total of 480 participants were assigned randomly in a ratio of 2:1 to receive a single intramuscular dose (0.5 ml) of the vaccine (15 µg of hemagglutinin per strain) or placebo (phosphate-buffered saline). Participants were monitored for safety, including solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs). No SAEs related to vaccination were reported. Injection site pain (51.3%), injection site tenderness (40.4%), tiredness (17.0%), and headache (15.1%) were the most commonly reported solicited events in the vaccine group. Incidence of related unsolicited AEs was low (1.3%) among vaccinees. Hemagglutinin inhibition (HAI) titers were measured before and 21 days after vaccination in 151 participants. Overall, HAI seroconversion rates to H1 and H3 were observed in 90.1% and 76.2% of vaccinees, respectively. For B antigen, it was 51.5%, likely due to high pre-vaccination titers. Post-vaccination seroprotection rates were in the range of 78.2–95.0% for the three antigens. Post-vaccination geometric mean titers (GMT) were at least 3.8 times higher than baseline levels for all the three strains among vaccinees. Overall, the study showed that the vaccine was safe and well tolerated, and induced a robust immune response against all three vaccine strains. ClinicalTrials.gov identifier: NCT02935192, October 17, 2016

scholarly journals Safety and Immunogenicity of CoronaVac and ChAdOx1 Against the SARS-CoV-2 Circulating Variants of Concern (Alpha, Delta, Beta) in Thai Healthcare Workers

2021 ◽  
Author(s):  
Nasikarn Angkasekwinai ◽  
Jaturong Sewatanon ◽  
Suvimol Niyomnaitham ◽  
Supaporn Phumiamorn ◽  
Kasama Sukapirom ◽  
...  
Keyword(s):  
Neutralizing Antibodies ◽  
Care Center ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Tertiary Care ◽  
Adenovirus Vector ◽  
Electronic Diary ◽  
Vector Vaccine ◽  
Resource Limited ◽  
Care Workers

Importance: Inactivated vaccine (CoronaVac) and chimpanzee adenovirus-vector vaccine (ChAdOx1) have been more available in resource-limited settings. However, the data comparing between these two vaccines in the same setting are limited. Objectives: To determine adverse events (AEs) and immunogenicity of CoronaVac and ChAdOx1 in health care workers (HCWs). Design: This prospective study was conducted from February to July 2021. Setting: A single center, university-based tertiary care center in Bangkok. Participants: Healthy HCWs. Exposure: Two doses of CoronaVac (4 weeks apart) or ChAdOx1 (8 weeks apart) intramuscularly. Main Outcomes and Measures: Self-reported AEs were collected for 7 days following each vaccination using electronic diary. The immunogenicity was determined by the level of IgG antibodies against receptor binding domain (RBD) of the SARS-CoV-2 spike protein (S1 subunit). The 50% plaque reduction neutralization tests against original Wuhan strain and circulating VOCs were performed in subset of samples at 2 weeks after the second dose. Results: Of the 360 HCWs, 180 received each vaccine. The median (interquartile range: IQR) age was 35 (29-44) years old and 84.2% were female. Participants who received ChAdOx1 reported higher frequency of AEs than those received CoronaVac after both the first dose (84.4% vs. 66.1%, P < 0.001) and second dose (75.6% vs. 60.6%, P = 0.002), with more AEs in those younger than 30 years of age for both vaccines. The seroconversion rate was 75.6% and 100% following the first dose of CoronaVac and ChAdOx1, respectively. All participants seroconverted at 2 weeks after the second dose. The anti-SARS-CoV-2 RBD IgG levels induced by CoronaVac was lower than ChAdOX1 with geometric means of 164.4 and 278.5 BAU/mL, respectively (P = 0.0066). Both vaccines induced similar levels of neutralizing antibodies against the Wuhan strain, geometric mean titer (GMT) of 337.4 vs 331.2; however, CoronaVac induced significantly lower GMT against Alpha (23.1 vs. 92.5), Delta (21.2 vs. 69.7), and Beta (10.2 vs. 43.6) variants, respectively. Conclusions and Relevance: CoronaVac induces lower measurable antibodies but with lower frequency of AEs than ChAdOx1. The low neutralizing antibodies against the circulating VOCs induced by CoronaVac supports the need for earlier boosting to prevent breakthrough infections. Trial Registration: TCTR20210720002 https://www.thaiclinicaltrials.org/

scholarly journals 16. A Randomized Phase 1 Study of a Novel Pneumococcal Conjugate Vaccine in Healthy Japanese Adults in the United States

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S30-S31
Author(s):  
David Fitz-Patrick ◽  
Mariano Young Jr. ◽  
Daniel Scott ◽  
Ingrid L Scully ◽  
Gary Baugher ◽  
...  
Keyword(s):  
United States ◽  
Conjugate Vaccine ◽  
Phase 1 ◽  
Geometric Mean ◽  
Age Groups ◽  
Unmet Need ◽  
The United States ◽  
Double Blind Study ◽  
Double Blind ◽  
Japanese Adults

Abstract Background Because of the number and variability of serotypes causing pneumococcal disease among different geographic regions, age groups, and environmental backgrounds, expanding serotype coverage with pneumococcal conjugate vaccines (PCVs) is a continued unmet need. Methods This phase 1, randomized, double-blind study included healthy Japanese adults aged 18–49 years residing in the United States. Subjects were randomized 1:1:1 to receive a single dose of a 20-valent PCV (containing 13-valent PCV [PCV13] serotypes plus 8, 10A, 11A, 12F, 15B, 22F, 33F), a novel pneumococcal polysaccharide conjugate vaccine with extended coverage, or PCV13 (control). Safety was the primary endpoint and included reactogenicity events occurring ≤ 14 days after vaccination, adverse events (AEs) ≤ 1 month after vaccination, and serious AEs (SAEs) ≤ 6 months after vaccination. The secondary endpoint was pneumococcal serotype-specific immunogenicity as determined by opsonophagocytic activity (OPA) titers on sera collected before and 1 month after vaccination. Results Overall, 35 subjects received PCV20 and 35 subjects received PCV13. One subject withdrew before the 1-month follow-up. Local reactions and systemic events across groups were generally mild or moderate (Figure 1). Two vaccine-related AEs occurred (injection site erythema and swelling in the PCV20 group); no severe AEs, SAEs, or safety-related withdrawals were reported. OPA geometric mean titers increased for all 20 serotypes in the PCV20 group and all 13 serotypes in the PCV13 group 1 month after vaccination; corresponding OPA geometric mean fold rises from baseline to 1 month after vaccination are reported (Figure 2; Figure 3). Figure 1 Figure 2 Figure 3 Conclusion PCV20 was well tolerated and induced serotype-specific functional OPA immune responses that are anticipated to be associated with protection in Japanese adults. ClinicalTrials.gov: NCT03642847. Funding: Pfizer Inc. Disclosures David Fitz-Patrick, MD, Pfizer Inc (Grant/Research Support) Mariano Young Jr., MD, Pfizer Inc (Employee, Shareholder) Daniel Scott, MD, Pfizer (Employee, Shareholder) Ingrid L. Scully, PhD, Pfizer Inc (Employee, Shareholder) Gary Baugher, PharmD, Pfizer Inc (Employee, Shareholder) Yahong Peng, PhD, Pfizer (Employee, Shareholder) Kathrin U. Jansen, PhD, Pfizer (Employee, Shareholder) William C. Gruber, MD, Pfizer (Employee, Shareholder) Wendy Watson, MD, Pfizer (Employee, Shareholder)

scholarly journals Persistent Antibody Responses to SARS-CoV-2 Infection in Cancer Patients: A Single-Center Retrospective Observational Study

2021 ◽  
Vol 42 (02) ◽  
pp. 123-129
Author(s):  
Amit Agarwal ◽  
Saphalta Baghmar ◽  
Suhail Qureshi ◽  
Aseem Khurana ◽  
Rasika Setia ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Seroconversion Rate ◽  
Age Groups ◽  
Humoral Response ◽  
Disease Status ◽  
Serum Samples ◽  
Cancer Disease ◽  
Care Workers ◽  
Antibody Levels ◽  
Roche Diagnostics

Abstract Introduction There is limited literature available regarding the prevalence and durability of immune response to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/coronavirus disease 2019 (COVID-19) in cancer patients. Objective The aim of this study was to analyze the seroconversion rate in cancer patients recovered from SARS-CoV-2 infection. Materials and Methods We retrospectively analyzed antibody levels and seroconversion rates in serum samples from 135 cancer patients who had recovered from SARS-CoV-2 infection. Chemiluminescent immunoassay using Roche Cobas e801 analyzer (Roche Diagnostics, Rotkreuz, Switzerland) was performed to identify Pan Ig antibody against nucleocapsid antigen. Reports of first, third, and sixth month were analyzed. Seroconversion was also compared with health-care workers (HCW) of our institute who had recovered from COVID-19 infection. Results Seroconversion rate in cancer patients was 81.2% at 1 month, 95% at 3 months, and 94.6% at 6 months post reverse transcriptase–polymerase chain reaction positivity. There was no difference in seroconversion rate among different age groups, gender, comorbidities, severity of COVID-19 symptoms, cancer disease status, and treatment with chemotherapy. Seroconversion rate in cancer patients is comparable to HCW (90.4 vs. 96%, p = 0.82) and is durable. Conclusion Humoral response to COVID-19 infection in cancer patients is comparable to general population and sustained. Such responses suggest that cancer patients are likely to benefit from COVID-19 vaccination.

Sign in / Sign up

Export Citation Format

Share Document