Effective Immune Response In Patients Who Have Hematologic Malignancies After Vaccination with Inactivated Influenza A (H1N1) 2009 Monovalent Vaccine

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1743-1743
Author(s):  
Yiqing Xu ◽  
Nanda K Methuku ◽  
Praveena Coimbatore ◽  
Theresa Fitzgerald ◽  
Yiwu Huang ◽  
...  

Abstract Abstract 1743 Introduction: Effective vaccinations against 2009 H1N1 have been reported in healthy individuals; however, the response of immunocompromised patients, particularly patients who have hematologic malignancies and who also may be taking cytotoxic myelosuppressive and immunosuppressive treatments, is unclear and is generally considered to be decreased. Methods: We conducted a prospective study to test the immunogenicity of H1N1 vaccination in patients with hematologic malignancies. We enrolled 22 patients, all of them received inactivated monovalent H1N1 2009 vaccine made by Sanofi. Antibody responses were measured by hemaglutination inhibition assay (HAI) at 4–6 weeks and 6–16 weeks. Results: Among the 22 patients, there were 15 males, 7 females, median age 61.5y (range 35–86y). Sixteen patients had active disease, with MGUS+MM (n=4), CLL+NHL (n=5), MDS+AML (n=4) and MPD (n=3), while the other 6 patients were in remission (within 3 years of initial diagnosis), including MM (n=1), CLL+NHL+HD (n=3), AML (n=1) and MPD (n=1). Eleven patients were receiving treatment (within 28 days before or after vaccination) with drugs that have myelosuppressive potential (91%), and 54.5% of the patients were also receiving drugs that have immunosuppressive potential. The median interval of treatment prior to vaccination was 6 days (range 0–84 d) and the median interval of treatment after vaccination was 14 days (0-28 d). At baseline, 23.0% (95% confidence interval [CI], 4–42%) patients had antibody titer ≥ 1:40, and the geometric mean titer was 18.2 (95%CI, 8.6–38.7); at 4–6 weeks, the geometric mean titer was 197.0 (95%CI, 86.5–448.4), and the geometric mean ratio was 12.1 (95%CI 5.28–27.9). The seroconversion rate (4 fold increase in the antibody titer and ≥1:40) was 75% (95%CI, 54–96%), and the post-vaccination seroprotection rate (titer ≥1:40) was 90% (95%CI, 77–100%). When re-tested at 6–16 weeks, the results were not significantly different. Among the 5 patients (25%) who did not show seroconversion, 2 had very high baseline protection titers, 2 did not attain seroprotective titers after vaccination, another one did not show protective titer at 6 weeks, but mounted a titer of 1:40 at 10 weeks. No serious adverse events or hospital admissions from H1N1 infection were documented at 6 months of follow up. Subgroup analyses were performed to evaluate the influence on seroconversion rates of potential factors including (1) the presence or absence of active disease, (2) lymphoproliferative disorders versus myeloid disorders, (3) myelosuppressive drugs, (4) immunosuppressive drugs, and none showed a significant difference. Three patients were treated with Rituximab based chemotherapy, 1 patient who had R-CHOP for NHL showed robust response at 4–6 weeks, while 1 patient who had CLL treated with FCR, and another one with NHL treated with R-Bendamustine failed to develop response. These are the only 2 patients who did not show seroconversion or seroprotective titers in this study. Conclusion: Patients with hematologic malignancies are able to generate an immune response to the H1N1 vaccine. The lower boundaries of CI of seroconversion rate (54%) and that of seroprotection rate (77%) are above what are recommended by the US FDA for an effective vaccine. Among the patients who developed an immune response, all but one demonstrated response within 4–6 weeks. Patients receiving Rituximab based treatment nevertheless can generate an effective immune response. Disclosures: No relevant conflicts of interest to declare.

2020 ◽  
Vol 22 ◽  
pp. 02001
Author(s):  
O.P. Kovtun ◽  
V.V. Romanenko ◽  
I.V. Feldblum ◽  
A.U. Sabitov ◽  
A.V. Ankudinova

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.


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 ◽  
...  

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.


2018 ◽  
Vol 146 (16) ◽  
pp. 2079-2085 ◽  
Author(s):  
M. Petráš ◽  
V. Oleár

AbstractAn evaluation of the relationship between predictors and immune response was conducted using data obtained from a clinical trial in 200 Czech healthy adults aged 24–65 years receiving a booster dose of a monovalent tetanus vaccine in 2017. The response was determined from ELISA antibody concentrations of paired sera obtained before and 4 weeks after the immunisation. While all subjects with initial antibody levels <1.2 IU/ml achieved a 100% seroconversion rate (at least a fourfold rise in antibodies), only 8% seroconversion was documented in subjects with initial levels >2.2 IU/ml. The immune response was not affected by sex, age, tetanus vaccine type, concomitant medication, related adverse events or post-vaccination period since there were no significant differences in geometric mean concentrations or seroconversion rates. The seroconversion rate of 56% in smokers was significantly lower than that of 73% achieved in non-smokers. Although the seroconversion rates did not differ between individuals with normal or higher body weight, the adjusted odds ratio (1.3; 95% Cl 1.08–1.60) revealed a positive correlation between seroconversion rate and body mass index (BMI). Although the vaccine-induced response was influenced by pre-vaccination antibody levels, smoking or BMI, the booster immunisation against tetanus produced a sufficient response regardless the predictors.


2012 ◽  
Vol 23 (7) ◽  
pp. 464-467 ◽  
Author(s):  
S Kourkounti ◽  
N Mavrianou ◽  
Va Paparizos ◽  
K Kyriakis ◽  
M Hatzivassiliou ◽  
...  

HIV-infected patients are at increased risk for acquiring hepatitis A virus (HAV) infection. We evaluated the seroconversion rate (anti-HAV antibodies ≥ 20 mIU/ml) and the geometric mean antibody titres (GMTs) in a group of 351 HIV infected men, who had received two doses of a hepatitis A vaccine. We analysed blood samples collected at one, six, 12 and 18 months following the administration of the second dose of the vaccine. The seroconversion rate one month after the second dose of the vaccine was 74.4% (260/351). At month 18 after the end of vaccination, 56.1 % of the subjects remained seropositive. GMTs were 315, 203,153 and 126 mIU/ml at months 1,6, 12, and 18, respectively. Logistic regression revealed that the CD4 count is the only factor affecting response to vaccination ( P = 0.019). A higher response rate and higher GMTs were observed in patients with CD4 counts ≥500 cells/mm3 (76.6%) than in patients with CD4 counts 200–499 cells/mm3. In conclusion, even in patients with near-normal CD4 counts, the response to the hepatitis A vaccine is impaired.


2017 ◽  
Vol 19 (3) ◽  
pp. 141-147 ◽  
Author(s):  
Lahar Mehta ◽  
Kimberly Umans ◽  
Gulden Ozen ◽  
Randy R. Robinson ◽  
Jacob Elkins

Background: For patients with relapsing-remitting multiple sclerosis (RRMS) undergoing continuous immunomodulatory therapy, understanding whether vaccinations can be performed safely and effectively is important. We tested the immune response to inactivated seasonal influenza vaccine during long-term daclizumab beta treatment. Methods: In this prospective, open-label, single-arm extension SELECTED study, an optional vaccine substudy was performed on patients with RRMS who had already received daclizumab beta for 1 to 2 years in previous studies. Patients were administered the seasonal vaccine as a single intramuscular dose containing three inactivated influenza virus strains: A/California/7/2009 (A/H1N1), A/Texas/50/2012 (A/H3N2), and B/Massachusetts/2/2012 (B). Endpoints included proportion of patients achieving seroprotection, proportion of patients who seroconverted, geometric mean titer ratio before and after vaccination, and adverse events reported during 28-day follow-up. Results: Ninety patients received the influenza vaccine (mean previous daclizumab beta exposure, 49.6 doses). Seroprotection (anti–hemagglutination immunoglobulin G titer ≥40) was detected in 92% (95% confidence interval [CI], 85%–97%) of patients for A/H1N1, 91% (83%–96%) for A/H3N2, and 67% (56%–76%) for B. The proportion of patients who seroconverted was 69% (95% CI, 58%–78%) for A/H1N1, 69% (58%–78%) for A/H3N2, and 44% (34%–55%) for B. The anti–hemagglutination immunoglobulin geometric mean titer ratio was 7.7 for A/H1N1, 9.0 for A/H3N2, and 4.3 for B. There were no significant adverse events considered related to vaccination during 28-day follow-up. Conclusions: Patients with RRMS receiving long-term daclizumab beta treatment mounted an immune response to the seasonal influenza vaccine at levels considered to confer protection. No major or new safety issues were identified.


2017 ◽  
Vol 16 (2) ◽  
pp. 24-30 ◽  
Author(s):  
S. M. Kharit ◽  
D. A. Lioznov ◽  
A. A. Ruleva ◽  
I. V. Fridman ◽  
N. V. Chirun ◽  
...  

Objective. To compare the reactogenicity and immunogenicity of inactivated influenza vaccines: Grippol Plus polymer subunit vaccine, Influvac subunit vaccine, and Vaxigrip split vaccine as part of influenza prevention in people aged 18 - 55 with no pre-existing conditions. Materials and methods. Comparative study of three groups of volunteers with no pre-existing conditions using coded serum samples. Randomisation: 1:1:1. Group 1:100 people vaccinated with Grippol® Plus, Group 2:100 people vaccinated with Influvac, Group 3: 100 people vaccinated with Vaxigrip. The study looked into the levels of specific hemagglutination-inhibition antibodies to influenza viruses in a standard hemagglutination inhibition assay (HAI), with the coding of sera obtained before the vaccination and 28 days post-vaccination. The seroconversion rate (share of patients with the antibody titer increase of more than 4x) and seroprotection rate (share of patients with antibody titer > 1:40) were measured. Reactogenicity was evaluated based on the intensity of systemic and local reactions during the first five days post-vaccination. Results. Reactogenicity: in general the number and intensity of systemic and local reactions in all the groups was insignificant, the reactions were mild and required no treatment with medications. Tolerability levels were high. There was a reliable decline in local reactions to subunit vaccines over time. Immunogenicity: the seroprotection rate for the A/H1N1 strain on day 28 post-vaccination was 95.0% for the Grippol Plus group, 95.0% for the Influvac group, and 96.0% for the Vaxigrip group. The seroprotection rate for the A/H3N2 strain on day 28 post-vaccination was 90.9% for the Grippol Plus group, 90.0% for the Influvac group, and 96.0% for the Vaxigrip group. The seroprotection rate for the B strain on day 28 post-vaccination was 99.0% for the Grippol Plus group, 100.0% for the Influvac group, and 100.0% for the Vaxigrip group. Conclusion: the study found that the Grippol Plus, Influvac, and Vaxigrip vaccines have similar efficacy in vaccination against the A/H1N1, A/H3N2, and В strains 28 days post-vaccination. All the vaccines tested were in line with the CPMP requirements to the immunogenicity of human influenza vaccines. All the vaccines had a similar safety profile, but the incidence of injection site pain, swelling and itching was reliably lower in those vaccinated with the Grippol Plus and Influvac vaccines as compared to the Vaxigrip vaccine.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S952-S953
Author(s):  
Dissaruj Tovikkai ◽  
Jakapat Vanichanan ◽  
Kamonwan Jutivorakool

Abstract Background Immunization were the key of prevention in tetanus and diphtherial disease. Nevertheless, in previous observational study, low seroprotection rate of both diphtheria and tetanus were observed in Thai healthy population. Reduced-dose diphtheria and tetanus toxoid vaccine (dT) was recommended to all adult patients regardless of immunologic status. However, data on vaccine efficacy in interferon gamma (IFN-γ) autoantibody were limited. We therefore conducted clinical study to evaluate efficacy and safety of one dose of dT in IFN-γ autoantibody patient compared with healthy individuals at 4 weeks after vaccination. Methods Study was conducted from February to April 2019. Total 18 patients with confirmed IFN-γ autoantibody were enrolled. Baseline tetanus and diphtheria serologic study and 4 weeks after vaccination were examined. Antibody levels were measured with a solid-phase IgG-specific ELISAs (EUROIMMUN, Germany). Geometric mean titers (GMTs) were calculated using the log transformation of serological titers and from taking the antilog mean of the transformed values. Results Seroprevalence of tetanus was 94.5% in healthy population compared with 60.1% in IFN-γ autoantibody patients. While, seroprevalence of diphtheria was 27.8% and 77.8%, respectively. After vaccination, all healthy adults had reached seroprotection level in both diphtheria and tetanus. For patients with IFN-γ autoantibody, 88.9% and 94.4% had anti-tetanus toxin IgG and anti-diphtheria toxin IgG level above 0.1 IU/mL, respectively. These results indicated seroconversion rate of 71% for tetanus and 75% for diphtheria after dT vaccination. (Table 2). In the subgroup analysis, unboosted IFN-γ autoantibody patient had lower tetanus seroconversion rate compared with previously boosted patient (50% vs 100%). Active infection was also associated with lower immune response after tetanus vaccination. There was no severe adverse event in both group. Conclusion This is the first study on immune response after dT vaccination in IFN-γ autoantibody patient. Seroconversion rate of dT vaccine in IFN-γ autoantibody patient were slightly lower than healthy adults. Active infection and previously unboosted patient provided lower immune response of tetanus. Disclosures All authors: No reported disclosures.


PEDIATRICS ◽  
1970 ◽  
Vol 45 (4) ◽  
pp. 636-639
Author(s):  
Carol F. Phillips ◽  
Charles A. Phillips ◽  
Ben R. Forsyth

Twenty-two of 30 children residing in a children's center and 32 adult employees received a single inoculation of purified, killed, monovalent, influenza virus vaccine prepared with the Hong Kong variant of influenza A2 virus. All children showed significant four-fold or greater rises in HI antibody titer following vaccination, while 28 of 32 adults (88%) showed four-fold or greater rises in HI antibody titer. Twenty-five children living outside of the children's center were also immunized and those from whom paired sera were obtained (eight) showed four-fold or greater rises in HI antibody titer. Geometric mean titer rises from &lt;10 to 93.6 in children and from &lt; 10 to 70.9 in adults were recorded. Local reactions were limited to mild redness in one half of the children, and transient redness or soreness was seen in one half of the adults. No systemic reactions were seen in the children, but one adult had fever and malaise of 24 hours' duration. In contrast to previously available influenza vaccines, the highly purified vaccine seems to be more satisfactory for use in children of school age; it should be particularly advantageous for use in children who are being immunized because of an underlying debilitating disease.


2022 ◽  
Author(s):  
Shi Zou ◽  
Mengmeng Wu ◽  
Fangzhao Ming ◽  
Songjie Wu ◽  
Wei Guo ◽  
...  

Abstract Background: Multi-types COVID-19 vaccines have shown safety and efficacy against COVID-19 in adults. Although current guidelines encourage people living with HIV(PLWH) to take COVID-19 vaccines, whether their immune response to COVID-19 vaccines is distinct from HIV-free individuals is still unclear. Methods: Between March to June 2021, 48 PLWH and 40 HNC, aged 18 to 59 years, were enrolled in the study in Wuchang district of Wuhan city. All of them received inactivated COVID-19 vaccine at day 0 and the second dose at day 28. The primary safety outcome was the combined adverse reactions within 7days after each injection. The primary immunogenicity outcomes were neutralizing antibodies (nAbs) responses by chemiluminescence and total specific IgM and IgG antibodies responses by ELISA and colloidal gold at baseline (day 0), day 14, day 28, day 42, and day 70.Results: In total, the study included 46 PLWH and 38 HNC who finished 70 days’ follow-up. The frequency of adverse reactions to the first and second dose was not different between PLWH (30% and 11%) vs HNC (32% and 24%). There were no serious adverse events. NAbs responses among PLWH peaked at day 70, while among HNC peaked at day 42. At day 42, the geometric mean concentration (GMC) and seroconversion rate of nAbs among PLWH were 4.46 binding antibody units (BAU)/mL (95% CI, 3.18-5.87) and 26% (95% CI, 14-41), which were lower than that among HNC [GMC (18.28 BAU/mL, 95% CI, 10.33-32.33), seroconversion rate (63%, 95% CI, 44-79)]. IgG responses among both PLWH and HNC peaked at day 70. At day 70, the geometric mean ELISA units (GMEU) and seroconversion rate of IgG among PLWH were 0.193 ELISA units (EU)/mL (95% CI, 0.119-0.313) and 51% (95% CI, 34-69), which was lower than that among HNC [GMEU (0.379 BAU/mL, 95% CI, 0.224-0.653), seroconversion rate (86%, 95% CI, 64-97)]. Conclusion: Early humoral immune response to the inactivated COVID-19 vaccine was weaker and delayed among the PLWH population than that among HNC. This observation remained consistent regardless of a high CD4 count and a low HIV viral load suppressed by antiretroviral therapy (ART).


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ernesta Cavalcanti ◽  
Maria Antonietta Isgrò ◽  
Domenica Rea ◽  
Lucia Di Capua ◽  
Giusy Trillò ◽  
...  

Abstract Background Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally, requiring the development of billions of different vaccine doses. The SARS-CoV-2 spike mRNA vaccine (named BNT162b2/Pfizer), authorized by the FDA, has shown high efficacy in preventing SARS-CoV-2 infection after administration of two doses in individuals 16 years of age and older. In the present study, we retrospectively evaluated the differences in the SARS-CoV-2 humoral immune response after vaccine administration in the two different cohorts of workers at the INT - IRCCS “Fondazione Pascale” Cancer Center (Naples, Italy): previously infected to SARS-CoV-2 subjects and not infected to SARS-CoV-2 subjects. Methods We determined specific anti-RBD (receptor-binding domain) titers against trimeric spike glycoprotein (S) of SARS-CoV-2 by Roche Elecsys Anti-SARS-CoV-2 S immunoassay in serum samples of 35 healthcare workers with a previous documented history of SARS-CoV-2 infection and 158 healthcare workers without, after 1 and 2 doses of vaccine, respectively. Moreover, geometric mean titers and relative fold changes (FC) were calculated. Results Both previously infected and not infected to SARS-CoV-2 subjects developed significant immune responses to SARS-CoV-2 after the administration of 1 and 2 doses of vaccine, respectively. Anti-S antibody responses to the first dose of vaccine were significantly higher in previously SARS-CoV-2-infected subjects in comparison to titers of not infected subjects after the first as well as the second dose of vaccine. Fold changes for subjects previously infected to SARS-CoV-2 was very modest, given the high basal antibody titer, as well as the upper limit of 2500.0 BAU/mL imposed by the Roche methods. Conversely, for naïve subjects, mean fold change following the first dose was low ($$ \overline{x} $$ x ¯ =1.6), reaching 3.8 FC in 72 subjects (45.6%) following the second dose. Conclusions The results showed that, as early as the first dose, SARS-CoV-2-infected individuals developed a remarkable and statistically significant immune response in comparison to those who did not contract the virus previously, suggesting the possibility of administering only one dose in previously SARS-CoV-2-infected subjects. FC for previously infected subjects should not be taken into account for the generally high pre-vaccination values. Conversely, FC for not infected subjects, after the second dose, were = 3.8 in > 45.0% of vaccinees, and ≤ 3.1 in 19.0%, the latter showing a potential susceptibility to further SARS-CoV-2 infection.


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