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1.
Vaccinology and Methods in Vaccine Research ; : 295-310, 2022.
Article in English | Scopus | ID: covidwho-2035540

ABSTRACT

A vaccine clinical trial is a research study in humans which aims to investigate or confirm the clinical, pharmacological, or immunological effects of a vaccine to establish the vaccine’s safety and/or efficacy. Once a promising vaccine candidate has been chosen from preclinical studies, it goes through a number of phases of clinical trials in humans before and after licensure. Ensuring the trial is designed correctly to answer the specific question(s) or objective(s) is of primary importance. In addition, the clinical trial must be conducted according to the principles of good clinical practice (GCP). The primary tenants of GCP are minimizing risk to the participant, safeguarding participants, informed consent, adhering to an approved research protocol, and ensuring data integrity. This chapter outlines how to plan and run a clinical vaccine trial including the principles and application of GCP, trial design, documentation, regulatory requirements, data quality, and safety considerations. © 2022 Elsevier Inc. All rights reserved.

2.
Eur J Ophthalmol ; : 11206721221124651, 2022.
Article in English | Web of Science | ID: covidwho-2020984

ABSTRACT

PURPOSE: To present a case of branch retinal vein occlusion (BRVO) following ChAdOx1 nCoV-19 (Oxford-AstraZeneca) Vaccine. METHODS: Case report. RESULTS: A 60-year old otherwise healthy Caucasian male, presented to the ophthalmology emergency clinic complaining of sudden, painless vision loss in his right eye of 24 h" duration. The patient had received Vaxveria seven days prior. The clinical and fundus examination of the right eye established the diagnosis of BRVO. CONCLUSION: The present case descibes the occurrence of BRVO soon after the vaccination with the Oxford-AstraZeneca vaccine. The close temporal relationship between the BRVO incidence and the vaccination is reinforced by the lack of othe subjective cause to justify the episode.

3.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-1996605

ABSTRACT

Introduction Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18-60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and Discussion A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell’s palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.

4.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-1996602

ABSTRACT

Background Post-marketing surveillance for COVID-19 vaccines during the pandemic identified an extremely rare thrombosis with thrombocytopenia syndrome (TTS) reported post-vaccination, requiring further characterisation to improve diagnosis and management. Methods We searched the AstraZeneca Global Safety Database (through April 26, 2021) for cases with co-reported thrombocytopenia and thrombosis (using standardised MedDRA queries/high-level terms) following AZD1222 (ChAdOx1 nCoV-19). Cases were adjudicated by experts as ‘typical’,’possible’, ‘no’ or ‘unknown’ according to available TTS criteria. Additional confirmatory datasets (May 20–June 20, October 1–December 28) were evaluated. Findings We identified 573 reports, including 273 (47.6 %) ‘typical’ and 171 (29.8 %) ’possible’ TTS cases. Of these 444 cases, 275 (61.9 %) were female, median age was 50.0 years (IQR: 38.0–60.0). Cerebral venous sinus thrombosis was reported in 196 (44.1 %) cases, splanchnic venous thrombosis in 65 (14.6 %) and thromboses at multiple sites in 119 (26.8 %). Median time to onset was 12.0 days (IQR: 9.0–15.0). Comparison with a pre-pandemic reference population indicated higher rates of autoimmune disorders (13.8 %, 4.4 %), previous heparin therapy (7.4 %, 1.2 %), history of thrombosis (5.5 %, 1.4 %), and immune thrombocytopenia (6.1 %, 0.2 %). Fatality rate was 22.2 % (127/573) overall and 23.6 % (105/444) in ‘typical’/’possible’ TTS, which decreased from 39.0 % (60/154) in February/March to 15.5 % (45/290) in April. Overall patterns were similar in confirmatory datasets. Conclusions The reporting rate of ‘typical’/’possible’ TTS post first-dose vaccination in this dataset is 7.5 per million vaccinated persons;few cases were reported after subsequent doses, including booster doses. Peak reporting coincided with media-driven attention. Medical history differences versus a reference population indicate potentially unidentified risk factors. The decreasing fatality rate correlates with increasing awareness and publication of diagnostic/treatment guidelines. Adjudication was hindered by unreported parameters, and an algorithm was developed to classify potential TTS cases;comprehensive reporting could help further improve definition and management of this extremely rare syndrome.

5.
Front Immunol ; 13: 882918, 2022.
Article in English | MEDLINE | ID: covidwho-1993786

ABSTRACT

In light of the decreasing immune protection against symptomatic SARS-CoV-2 infection after initial vaccinations and the now dominant immune-evasive Omicron variants, 'booster' vaccinations are regularly performed to restore immune responses. Many individuals have received a primary heterologous prime-boost vaccination with long intervals between vaccinations, but the resulting long-term immunity and the effects of a subsequent 'booster', particularly against Omicron BA.1, have not been defined. We followed a cohort of 23 young adults, who received a primary heterologous ChAdOx1 nCoV-19 BNT162b2 prime-boost vaccination, over a 7-month period and analysed how they responded to a BNT162b2 'booster'. We show that already after the primary heterologous vaccination, neutralization titers against Omicron BA.1 are recognizable but that humoral and cellular immunity wanes over the course of half a year. Residual responsive memory T cells recognized spike epitopes of the early SARS-CoV-2 B.1 strain as well as the Delta and BA.1 variants of concern (VOCs). However, the remaining antibody titers hardly neutralized these VOCs. The 'booster' vaccination was well tolerated and elicited both high antibody titers and increased memory T cell responses against SARS-CoV-2 including BA.1. Strikingly, in this young heterologously vaccinated cohort the neutralizing activity after the 'booster' was almost as potent against BA.1 as against the early B.1 strain. Our results suggest that a 'booster' after heterologous vaccination results in effective immune maturation and potent protection against the Omicron BA.1 variant in young adults.


Subject(s)
Antibodies, Neutralizing , COVID-19 , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Humans , SARS-CoV-2 , Vaccination , Young Adult
6.
Front Cardiovasc Med ; 9: 966028, 2022.
Article in English | MEDLINE | ID: covidwho-1993775

ABSTRACT

Various vaccines were developed to reduce the spread of the Severe Acute Respiratory Syndrome Cov-2 (SARS-CoV-2) virus. Quickly after the start of vaccination, reports emerged that anti-SARS-CoV-2 vaccines, including ChAdOx1-S, could be associated with an increased risk of thrombosis. We investigated the hemostatic changes after ChAdOx1-S vaccination in 631 health care workers. Blood samples were collected 32 days on average after the second ChAdOx1-S vaccination, to evaluate hemostatic markers such as D-dimer, fibrinogen, α2-macroglobulin, FVIII and thrombin generation. Endothelial function was assessed by measuring Von Willebrand Factor (VWF) and active VWF. IL-6 and IL-10 were measured to study the activation of the immune system. Additionally, SARS-CoV-2 anti-nucleoside and anti-spike protein antibody titers were determined. Prothrombin and fibrinogen levels were significantly reduced after vaccination (-7.5% and -16.9%, p < 0.0001). Significantly more vaccinated subjects were outside the normal range compared to controls for prothrombin (42.1% vs. 26.4%, p = 0.026) and antithrombin (23.9% vs. 3.6%, p = 0.0010). Thrombin generation indicated a more procoagulant profile, characterized by a significantly shortened lag time (-11.3%, p < 0.0001) and time-to-peak (-13.0% and p < 0.0001) and an increased peak height (32.6%, p = 0.0015) in vaccinated subjects compared to unvaccinated controls. Increased VWF (+39.5%, p < 0.0001) and active VWF levels (+24.1 %, p < 0.0001) pointed toward endothelial activation, and IL-10 levels were significantly increased (9.29 pg/mL vs. 2.43 pg/mL, p = 0.032). The persistent increase of IL-10 indicates that the immune system remains active after ChAdOx1-S vaccination. This could trigger a pathophysiological mechanism causing an increased thrombin generation profile and vascular endothelial activation, which could subsequently result in and increased risk of thrombotic events.

7.
Ther Adv Vaccines Immunother ; 10: 25151355221115009, 2022.
Article in English | MEDLINE | ID: covidwho-1993307

ABSTRACT

Background: COVID-19 infections among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-vaccinated individuals are of clinical concern, especially in those requiring hospitalization. Such real-world data on ChAdOx1 nCoV-19- and BBV152-vaccinated individuals are scarce. Hence, there is an urgent need to understand their clinical profile and outcomes. Methods: A 1:1 pair-matched study was performed among vaccinated and unvaccinated COVID-19 patients admitted between March 2021 and June 2021 at a tertiary care centre in New Delhi, India. The vaccinated group (received at least one dose of ChAdOx1 nCoV-19 or BBV152) was prospectively followed till discharge or death and matched [for age (±10 years), sex, baseline disease severity and comorbidities] with a retrospective group of unvaccinated patients admitted during the study period. Paired analysis was done to look for clinical outcomes between the two groups. Results: The study included a total of 210 patients, with 105 in each of the vaccinated and unvaccinated groups. In the vaccinated group, 47 (44.8%) and 58 (55.2%) patients had received ChAdOx1 nCoV-19 and BBV152, respectively. However, 73 patients had received one dose and 32 had received two doses of the vaccine. Disease severity was mild in 36.2%, moderate in 31.4% and severe in 32.4%. Two mortalities were reported out of 19 fully vaccinated individuals. All-cause mortality in the vaccinated group was 8.6% (9/105), which was significantly lower than the matched unvaccinated group mortality of 21.9% (23/105), p = 0.007. Vaccination increased the chances of survival (OR = 3.8, 95% CI: 1.42-10.18) compared to the unvaccinated group. Conclusion: In the second wave of the pandemic predominated by delta variant of SARS CoV-2, vaccination reduced all-cause mortality among hospitalized patients, although the results are only preliminary.

8.
Indian J Nephrol ; 32(4): 378-383, 2022.
Article in English | MEDLINE | ID: covidwho-1988207

ABSTRACT

With the ongoing mass COVID vaccination program, various case reports link the COVID-19 vaccines with heightened off-target immune responses leading to de novo development or relapse of various glomerular diseases. Very few glomerular diseases (totally nine published cases to date) have been reported post ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccination compared to more potent m RNA vaccine. In this case report, we present a case of de novo focal segmental glomerulosclerosis (FSGS) post ChAdOx1 nCoV-19 vaccination resistant to steroid and calcineurin inhibitor treatment. To our knowledge, this is the first case of FSGS tip variant reported after the ChAdOx1 nCoV-19 vaccination and the second de novo FSGS case post COVID vaccination (any types of COVID vaccines). We may expect more such types of cases resistant to conventional therapy as the global penetration of vaccination programs will improve.

9.
Vaccines (Basel) ; 10(6)2022 Jun 17.
Article in English | MEDLINE | ID: covidwho-1988037

ABSTRACT

We estimated the effectiveness of two doses of the ChAdOx1 nCoV-19 (Covishield) vaccine against any COVID-19 infection among individuals ≥45 years in Chennai, Tamil Nadu, India. A community-based cohort study was conducted from May to September 2021 in a selected geographic area in Chennai. The estimated sample size was 10,232. We enrolled 69,435 individuals, of which 21,793 were above 45 years. Two-dose coverage of Covishield in the 18+ and 45+ age group was 18% and 31%, respectively. Genomic analysis of 74 out of the 90 aliquots collected from the 303 COVID-19-positive individuals in the 45+ age group showed delta variants and their sub-lineages. The vaccine's effectiveness against COVID-19 disease in the ≥45 age group was 61.3% (95% CI: 43.6-73.4) at least 2 weeks after receiving the second dose of Covishield. We demonstrated the effectiveness of two doses of the ChAdOx1 vaccine against the delta variant in the general population of Chennai. We recommend similar future studies considering emerging variants and newer vaccines. Two-dose vaccine coverage could be ensured to protect against COVID-19 infection.

10.
Vaccines (Basel) ; 10(6)2022 Jun 16.
Article in English | MEDLINE | ID: covidwho-1988030

ABSTRACT

Patients with end-stage renal disease (ESRD) receiving hemodialysis (HD) were found to have a decreased immune response following mRNA COVID-19 immunization. ChAdOx1 nCoV-19 was a promising COVID-19 vaccine that performed well in the general population, but the evidence on immunogenicity in ESRD with HD patients was limited. Moreover, the immunological response to COVID-19 infection was inconclusive in patients with ESRD and HD. The aim of this study was to investigate the immunogenicity of ChAdOx1 nCoV-19 vaccination and the immunological response after COVID-19 infection in ESRD patients with HD. The blood samples were obtained at baseline, 1-month, and 3-month follow-up after each shot or recovery. All participants were measured for anti-spike IgG by the ELISA method, using Euroimmun. This study found a significant increase in anti-spike IgG after 1 month of two-shot ChAdOx1 nCoV-19 vaccination, followed by a significant decrease after 3 months. On the other hand, the anti-spike IgG was maintained in the post-recovery group. There was no significant difference in the change of anti-spike IgG between the one-shot ChAdOx1 nCoV-19-vaccinated and post-recovery groups for both 1-month and 3-month follow-ups. The seroconversion rate for the vaccinated group was 60.32% at 1 month after one-shot vaccination and slightly dropped to 58.73% at the 3-month follow-up, then was 92.06% at 1 month after two-shot vaccination and reduced to 82.26% at the 3-month follow-up. For the recovered group, the seroconversion rate was 95.65% at 1 month post-recovery and 92.50% at 3-month follow-up. This study demonstrated the immunogenicity of two-dose ChAdOx1 nCoV-19 in ESRD patients with HD for humoral immunity. After COVID-19 infection, the humoral immune response was strong and could be maintained for at least three months.

11.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-341918

ABSTRACT

Background: Although inactivated COVID-19 vaccines effectively prevent mortality, their effectiveness for preventing infection or severe illness is known to diminish Here we aimed to evaluate the immunogenicity and safety of three potential booster vaccines administered as a homologous booster or full- or half-dose heterologous boosters among individuals primed with CoronaVac. Methods: We conducted an observer-blind, randomized study of healthy Indonesian adults aged ≥18 years who had previously received two doses of CoronaVac within 3–<6 months or 6–9 months. Participants received a homologous booster with full-dose CoronaVac or heterologous boosters with ChAdOx1-S or BNT162b2 in full or half-dose. The primary outcome was to evaluate the seroconversion rate and geometric mean titres (GMTs) of IgG anti S-RBD 28 days after the booster in the per-protocol population. The secondary outcome was to evaluate the reactogenicity within 28 days after the booster. Findings: Healthy adults (n = 960) were enrolled. Twenty-eight days post-booster, combining early and late booster groups, seroconversion rates were highest for BNT162b2 (97·8% and 92·0% for full and half-dose), followed by ChAdOx1-S (87·9% and 81·5% for full and half-dose) and CoronaVac (41·3% to 66·3%). All booster groups achieved 100% seropositivity 28 days after boosting. Participants in the 6–9-months priming group had higher increases in GMT values compared with participants in the 3–<6-month priming group. For participants primed within 6–9 months before booster, GMT values 28 days post-booster were highest for BNT162b2 (19999·84 and 17017·62 for full and half-dose), followed by ChAdOx1-S (11258 and 7853·04 for full and half-dose) and CoronaVac (1440·55).No serious adverse events associated with the vaccines. Within the heterologous booster group, the AERs in half-dose were lower compared with full-dose. Interpretation: GMT values between participants in the 6–9 months priming group and the 3–<6 months priming group before the booster dose and between half dose and full dose groups 28 days post boster were not significantly different. Heterologous half- and full-dose vaccines as third doses resulted in more robust immune responses and better tolerated than homologous full-dose vaccines, therefore heterologous booster with half-dose BNT162b2 or ChAdOx1-S may be considered after 6–9 months of two doses of primary vaccine.

12.
Curr Drug Saf ; 2022 Aug 03.
Article in English | MEDLINE | ID: covidwho-1987301

ABSTRACT

BACKGROUND: COVISHIELD, ChAdOx1 nCoV- 19 Corona Virus Vaccine was granted emergency use authorization (EUA) as the first vaccine in India in January 2021. Knowing what to anticipate after vaccination will reduce vaccine hesitancy in the public. This study aimed to identify and measure the adverse events following COVID-19 vaccination. MATERIALS AND METHODS: A cross-sectional observational study was conducted at Goa Medical College, starting on February 21 till May 23, 2021. A total of 418 people were enrolled. We collected the data using the Microsoft Form and analyzed using Microsoft Excel and R-program. RESULTS: Of the 418 vaccine recipients, the incidence rate of AEFI (Adverse Events Following Immunization) was 54.31%. Fever, fatigue, and headache were the most commonly reported systemic AEFIs. Among these, 54.7% of AEFI were mild, 42.38% were of the moderate category, and only 2.96% were of grade 3 severity. None of the AEFIs were severe enough for hospitalization. Most of them developed symptoms within 24 hours of the first dose. Complete recovery from AEFIs took a median time of 24 hours. CONCLUSION: Most of our study findings were consistent with the phase 1, 2/3 trials findings of Oxford-AstraZeneca's ChAdOx1 vaccine. The AEFI symptoms were considered immune reactions to the vaccine. The AEFIs were more common among younger individuals and females. The chance of missing a serious adverse event like a thromboembolic phenomenon cannot be ruled out. We observed low AEFI rates with COVISHIELD in the Indian population compared to Oxford-AstraZeneca's ChAdOx1 vaccine in the UK-based population, which can be explained by pre-existing immunity against adenovirus in the Indian population. However, based on the study findings, we may interpret that the COVISHIELD, Serum Institute of India, carries a good safety profile overall.

13.
Hum Vaccin Immunother ; : 2104058, 2022 Aug 17.
Article in English | MEDLINE | ID: covidwho-1984961

ABSTRACT

INTRODUCTION: Cancer patients are more vulnerable to coronavirus disease 2019 (COVID-19) owing to their compromised immune status. However, data regarding COVID-19 vaccine safety and immune response in cancer patients are scarce. METHOD: This prospective, age- and sex-matched, single-center cohort study included 61 cancer patients and 122 healthy control participants. Seropositivity was defined as anti-S IgG titer >0.8 units/ml. Primary end point was seroconversion rate of immunoglobulin (Ig)G antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein (anti-S IgG) in cancer patients vs. healthy control participants following the second dose of COVID-19 vaccine ChAdOx1 nCoV-19 (AZD1222). RESULTS: After the second-dose vaccination, there was no difference in seropositivity rate between groups (57 [93.44%] patients with cancer vs. 121 [99.18%] control participants; geometric mean ratio [GMR]: 0.39; 95%CI: 0.01-10.46; p-value = 0.571). In contrast, after the first-dose vaccination, the seropositivity rate was significantly lower in the cancer patients than in the control participants (50/61 [81.97%] vs. 121/122 [99.18%]; GMR: 0.07; 95%CI: 0.01-0.71; p = 0.025). The median anti-S IgG titer after the first-and second dose vaccination were not significantly different between groups. Female sex was significantly associated with a higher anti-S IgG titer. 5FU- and taxane-based chemotherapy regimens were associated with a lower IgG titer. Side effects of vaccination were tolerable. CONCLUSIONS: The anti-S IgG seropositivity rate after completing the second vaccine dose did not differ between the cancer patients and control participants. However, the anti-S IgG seropositivity rate after the first-dose vaccination was lower in cancer patients.

15.
IJC Heart & Vasculature ; : 101108, 2022.
Article in English | ScienceDirect | ID: covidwho-1983173

ABSTRACT

Concerns have been raised recently about takotsubo cardiomyopathy (TCM) after receiving COVID-19 vaccines, particularly the messenger RNA (mRNA) vaccines. The goal of this study was to compile case reports to provide a comprehensive overview of takotsubo cardiomyopathy (TCM) associated with COVID-19 vaccines. A systematic literature search was conducted in PubMed, Scopus, Embase, Web of Science, and Google Scholar between 2020 and June 1, 2022. The study included individuals who developed cardiac takotsubo cardiomyopathy from receiving COVID-19 vaccinations. Ten studies, including 10 cases, participated in the current systematic review. The mean age was 61.8 years;90% were female, while 10% were male. 80% of the patients received the mRNA COVID-19 vaccine, while 20% received other types. In addition, takotsubo cardiomyopathy (TCM) occurred in 50% of patients receiving the first dose and another 40% after the second dose of COVID-19 vaccines. Moreover, the mean number of days to the onset of symptoms was 2.62 days. All cases had an elevated troponin test and abnormal ECG findings. The left ventricular ejection fraction (LVEF) was lower than 50% in 90% of patients. In terms of the average length of hospital stay, 50% stayed for 10.2 days, and all cases recovered from their symptoms. In conclusion, takotsubo (stress) cardiomyopathy (TCM) complications associated with COVID-19 vaccination are rare but can be life-threatening. Chest pain should be considered an alarming symptom, especially in those who have received the first and second doses of the COVID-19 vaccine.

16.
Therapie ; 2022 Jul 13.
Article in English | MEDLINE | ID: covidwho-1984120

ABSTRACT

The deficiently designed and conducted initial clinical development plan and the occurrence of thrombotic thrombocytopenia cases, have marked the 12-month journey of the AstraZeneca coronavirus disease 2019 (COVID-19) vaccine after it was first administered to humans. When it was authorized, there were no available efficacy data in the elderly. However, this age group was included in the product labelling based on immunogenicity data. The lack of safety and efficacy data in the elderly that was acknowledged in the product information, triggered most European Union (EU) countries to limit the administration of this vaccine to certain age groups. In February-March/2021, after the results of observational studies supported the vaccine effectiveness in the elderly, several countries broadened its use to this age group. When trust on the vaccine was ramping up, unusual blood clot cases were described in Europe, which led 24 countries around the world to temporarily halt its administration. These cases were first described as thrombotic thrombocytopenia in late March. In mid-April, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) updated the product information and confirmed the positive benefit/risk ratio of the vaccine, recommending its use with no age restrictions. The World Health Organization (WHO) coincided with this approach. However, several countries decided to limit its use to certain age groups. The EMA listed thrombotic thrombocytopenia as a "very rare" adverse reaction. Although, the AstraZeneca vaccine was conceived in early 2020 to be a worldwide leader in the fight against COVID-19, its use was abandoned by the African Union, Denmark, and Israel. However, this vaccine has shown its usefulness in many settings across the world.

17.
EClinicalMedicine ; 52: 101608, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-1982942

ABSTRACT

Background: Limited data exists regarding the efficacy of ChAdOx1-nCoV-19 vaccine against Severe acute respiratory syndrome coronavirus 2 (SARS­CoV­2) in solid cancer patients. We aimed to assess the immunogenicity of the ChAdOx1-nCoV-19 vaccine and the impact of different anticancer therapies for solid malignancies on immune response. Methods: This prospective, longitudinal observational study of immunogenicity following ChAdOx1-nCoV-19 vaccination among 385 solid cancer patients on active cancer treatment was conducted in two oncology centers. Participants received the first dose between June 18 and July 27, 2021 and the second dose at 8-10 weeks later. Blood samples were evaluated for total immunoglobulins against the receptor-binding of SARS-CoV-2 spike protein (anti-RBD total-Ig) before, and 4-week after the first- and second-doses. The primary endpoint was the geometric mean titers (GMT) of antibody among solid cancer patients compared to healthy controls and the impact of different cancer treatment types. Findings: Among solid cancer patients, the antibody level increased more slowly to significantly lower levels than achieved in healthy controls. The GMT at 4-weeks post-vaccination in cancer vs. healthy were 224.5 U/ml (95%CI 176.4-285.6) vs. 877.1 U/ml (95%CI 763.5-1008), p<0.0001), respectively. For different types of cancer treatments, chemotherapy agents, especially anthracyclines (GMR 0.004; 95%CI 0.002-0.008), paclitaxel (GMR 0.268; 95%CI 0.123-0.581), oxaliplatin (GMR 0.340; 95%CI 0.165-0.484), and immunotherapy (GMR 0.203; 95%CI 0.109-0.381) showed significantly lower antibody response. Anti-HER2, endocrine therapy and 5-fluouracil or gemcitabine, however, had less impact on the immune response. Interpretation: Suboptimal and heterogeneous immunologic responses were observed in cancer patients being treated with different systemic treatments. Immunotherapy or chemotherapy significantly suppressed the antibody response. Funding: Quality Improvement Fund, King Chulalongkorn Memorial Hospital, The Thai Red Cross Society and Center of Excellence in Clinical Virology at Chulalongkorn University and Chulalongkorn Medical Oncology Research Fund.

18.
Rinsho Shinkeigaku ; 62(6): 487-491, 2022 Jun 24.
Article in Japanese | MEDLINE | ID: covidwho-1979573

ABSTRACT

A 48-year-old Japanese man who had no previous medical history received his first dose of the ChAdOx1 nCoV-19 vaccine. Ten days after the vaccine administration, he developed a headache. Laboratory results indicated throm-bocytopenia and DIC. A head CT revealed microbleeding in the left parietal lobe. Contrast-enhanced CT showed thrombus in the left transverse sinus and left sigmoid sinus. A brain MRI demonstrated venous hemorrhagic infarction and subarachnoid hemorrhages in the left parietal lobe, and whole-body enhanced CT also revealed portal vein embolism and renal infarction. He was diagnosed with thrombosis with thrombocytopenia syndrome, and was treated according to the guideline. He has been recovering with the treatments. This is the first reported case of TTS associated with the ChAdOx1 nCoV-19 vaccine in Japan.


Subject(s)
Thrombocytopenia , Thrombosis , Humans , Infarction , Male , Middle Aged , Syndrome , Thrombocytopenia/etiology , Vaccination/adverse effects
19.
JAAD Case Rep ; 2022 Aug 10.
Article in English | MEDLINE | ID: covidwho-1977457
20.
Cell Rep Med ; 3(8): 100706, 2022 Aug 16.
Article in English | MEDLINE | ID: covidwho-1967222

ABSTRACT

Heterologous vaccination against coronavirus disease 2019 (COVID-19) provides a rational strategy to rapidly increase vaccination coverage in many regions of the world. Although data regarding messenger RNA (mRNA) and ChAdOx1 vaccine combinations are available, there is limited information about the combination of these platforms with other vaccines widely used in developing countries, such as BBIBP-CorV and Sputnik V. Here, we assess the immunogenicity and reactogenicity of 15 vaccine combinations in 1,314 participants. We evaluate immunoglobulin G (IgG) anti-spike response and virus neutralizing titers and observe that a number of heterologous vaccine combinations are equivalent or superior to homologous schemes. For all cohorts in this study, the highest antibody response is induced by mRNA-1273 as the second dose. No serious adverse events are detected in any of the schedules analyzed. Our observations provide rational support for the use of different vaccine combinations to achieve wide vaccine coverage in the shortest possible time.

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