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1.
Jornal de Pediatria ; 2022.
Article in English | ScienceDirect | ID: covidwho-2165618

ABSTRACT

Objective To present an updated review of recommendations for the vaccination of children with immune-mediated diseases, with an emphasis on rheumatic and inflammatory diseases. Source of data Studies published in the PubMed and Scielo databases between 2002 and 2022, Guidelines of Brazilian Scientific Societies, Manuals and Technical Notes of the Ministry of Health of Brazil, on current immunization schedules for special populations. Data synthesis Immunosuppressive drugs and biological agents reduce the immunogenicity of vaccines and favor susceptibility to infections. The safety and efficacy of immunogens are important points for vaccination in children with immune-mediated diseases. The safety threshold of a vaccine applied to immunocompromised individuals can be reduced when compared to healthy individuals. Very often, the recommendations for the immunization of children with immune-mediated diseases follow the recommendations for immunocompromised patients. Vaccination against COVID-19, on the other hand, should ideally occur when the disease is stabilized and in the absence of a low degree of immunosuppression. The patients should be informed about the possibility that the immunization may fail during treatment with immunosuppressants. Specific vaccination schedules should be considered to ensure better protection. Conclusions Recent studies have allowed updating the recommendations on the safety and immunogenicity of vaccination in children with immune-mediated diseases, especially for live attenuated vaccines. There is a scarcity of data on the safety and efficacy of COVID-19 vaccines in patients, particularly pediatric patients, with rheumatic diseases. The completion of ongoing studies is expected to help guide recommendations on COVID-19 vaccines in this group of patients.

3.
International Journal of Infectious Diseases ; 2022.
Article in English | ScienceDirect | ID: covidwho-2165391

ABSTRACT

Background : Regarding reactogenicity and immunogenicity, heterologous COVID-19 vaccination regimens are considered as alternative to conventional immunisation schemes. Methods : Individuals receiving either heterologous [ChAdOx1-S (AstraZeneca, Cambridge, UK)/BNT162b2 (Pfizer-BioNTech, Mainz, Germany)] (n=306) or homologous [mRNA-1273 (Moderna, Cambridge, Massachusetts, USA] (n=139) vaccination were asked to participate when receiving their second dose. Reactogenicity was assessed after 1 month, immunogenicity after 1, 3 and/or 6 months, including a third dose, via SARS-CoV-2 anti-Spike IgG, surrogate virus neutralisation test (sVNT) and a plaque reduction neutralisation test (PRNT) against the delta (B.1.167.2) and omicron (B.1.1.529;BA.1) variants of concern (VOCs). Results : Overall reactogenicity was lower after heterologous vaccination. In both cohorts, SARS-CoV-2 anti-Spike IgG concentrations waned over time to low neutralising levels in the delta PRNT after 6 months, where heterologous vaccination demonstrated higher neutralising activity than homologous mRNA vaccination. At this point, 3.2% of the heterologous and 11.4% of the homologous cohort yielded low neutralising activity against omicron. After a third dose of an mRNA-vaccine, ≥99% of vaccinees demonstrated positive neutralising activity against delta. Depending on the vaccination scheme and against omicron, 55.6% to 87.5% of vaccinees demonstrated positive neutralising activity. Conclusions : ChAdOx1-S/BNT162b2 vaccination demonstrated an acceptable reactogenicity and immunogenicity profile. A third dose of an mRNA-vaccine is necessary to maintain neutralising activity against SARS-CoV-2. However, VOC adapted versions of the vaccines would be desirable.

4.
EClinicalMedicine ; 54: 101680, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2158748

ABSTRACT

Background: More effective vaccine candidates against variants of concern as a booster dose are needed in people primed with two-dose inactivated COVID-19 vaccines. Methods: This randomised, double-blinded, investigator-initiated phase 2 trial aims to evaluate immunogenicity, durability, and safety of an mRNA vaccine candidate (RQ3013) and three other platform vaccines (an adenovirus-vectored vaccine candidate [ChAdTS-S], a recombinant protein vaccine candidate [ZR202-CoV], and an inactivated vaccine [CoronaVac]) as a booster. 250 eligible volunteers, who had received a prime two-dose CoronaVac (3 to 5 weeks apart) vaccination 100-270 days before, were randomly assigned in a 1:1:1:1:1 ratio to receive a third dose of RQ3013 (30 µg mRNA per 0.15 mL), ChAdTS-S (5×1010 viral particles per 0.5 mL), ZR202-CoV (25 µg prefusion-stabilized Spike ectodomain trimer per 0.5 mL), CoronaVac (3 µg inactivated CN02 strain of SARS-CoV-2 per 0.5 mL) or placebo (0.5 mL of 0.9% sodium chloride solution) via intramuscular injection into the upper arm at a single clinical site in Kunming, China. Participants, investigators, and immunogenicity laboratory were masked to group assignment. The primary immunogenicity outcomes were geometric mean titres (GMTs) of neutralising antibodies against live SARS-CoV-2 (wild-type, delta and omicron) virus at day 0 (before vaccination), day 7, day 14 and day 28 after vaccination, as analysed in a modified intention-to-treat (mITT) population (all participants who completed their booster doses and had at least one post-dose immunogenicity data). Secondary outcomes include T cell responses against the wild-type and omicron SARS-CoV-2 Spike protein. The primary safety outcome was incidence of adverse events within 14 days after the booster vaccination. This trial is registered with ChiCTR.org.cn, ChiCTR2200057758. Findings: Between January 1, 2022, and February 28, 2022, 235 eligible participants were enrolled and vaccinated, and the primary analysis included 234 participants. At baseline, neutralising antibodies against wild-type virus, the delta, or omicron variants were low or undetectable in all groups. After the booster vaccination, GMTs of neutralising antibodies ranged from 75.4 (95% confidence interval [CI] 61.4-92.5) in CoronaVac to 950.1 (95% CI 785.4-1149.3) in RQ3013 against live wild-type SARS-CoV-2, and from 8.1 (95% CI: 6.1-10.7) in CoronaVac to 247.0 (95% CI 194.1-314.3) in RQ3013 against the omicron variant at day 14. Immunogenicities of all heterologous regimens were superior to that of homologous regimen in neutralisation against all tested SARS-CoV-2 strains, with RQ3013 showing the highest geometric mean ratios (GMRs) of 12.6, 14.7, and 31.3 against the wild-type, the delta variant and the omicron variant compared to CoronaVac at day 14 post-vaccination, respectively. Durability analysis at day 90 showed that >90% of participants in RQ3013 and ZR202-CoV were seropositive for the omicron variant while ZR202-CoV with adjuvants containing CpG showed a slightly better durability than RQ3013. T cell responses specific to the omicron variant were similar to that of the wild-type, with RQ3013 showing the highest boosting effect. Any solicited injection site or systemic adverse events reported within 14 days after vaccination were most commonly observed in RQ3013 (47/47, 100%), followed by ZR202-CoV (46/47, 97.9%) and ChAdTS-S (43/48, 89.6%), and then CoronaVac (37/46, 80.4%) and placebo (21/47, 44.7%). More than 90% of the adverse events were grade 1 (mild) or 2 (moderate) with a typical resolution time of 3 days. No grade 4 adverse events or serious adverse events were reported by study vaccines. Interpretation: Although all study vaccines boosted neutralising antibodies with no safety concerns, RQ3013 showed much stronger cross-neutralisation and cellular responses, adding more effective vaccine candidates against the omicron variant. Funding: Yunnan Provincial Science and Technology Department China (202102AA100051 and 202003AC100010), the Double First-class University funding to Yunnan University, National Natural Science Foundation of China (81960116, 82060368 and 82170711), Yunnan Natural Science Foundation (202001AT070085), High-level Health Technical Personnel Project of Yunnan Province (H-2018102) and Spring City Plan: The High-level Talent Promotion and Training Project of Kunming.

5.
Journal of the Pakistan Medical Association ; 72(12):2582, 2022.
Article in English | EMBASE | ID: covidwho-2164797
6.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-2159912

ABSTRACT

Background In early 2020, developing vaccines was an urgent need for preventing COVID-19 from a contingency perspective. Methods S-268019-a is a recombinant protein-based vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), comprising a modified recombinant spike protein antigen adjuvanted with agatolimod sodium, a Toll-like receptor-9 agonist. In the preclinical phase, it was administered intramuscularly twice at a 2-week interval in 7-week-old mice. Immunogenicity was assessed, and the mice were challenged intranasally with mouse-adapted SARS-CoV-2 at 2 and 8 weeks, respectively, after the second immunization. After confirming the preclinical effect, a Phase 1/2, randomized, parallel-group clinical study was conducted in healthy adults (aged 20-64 years). All participants received 2 intramuscular injections at various combinations of the antigen and the adjuvant (S-910823/agatolimod sodium, in μg: 12.5/250, 25/250, 50/250, 25/500, 50/500, 100/500, 10/500, 100/100, 200/1000) or placebo (saline) in an equivalent volume at a 3-week interval and were followed up until Day 50 in this interim analysis. Results In the preclinical studies, S-268019-a was safe and elicited robust immunoglobulin G (IgG) and neutralizing antibody responses in mice. When challenged with SARS-CoV-2, all S-268019-a-treated mice survived and maintained weight until 10 days, whereas all placebo- or adjuvant-treated (without antigen) mice died within 6 days. In the Phase 1/2 trial, although S-268019-a was well tolerated in adult participants, was safe up to Day 50, and elicited robust anti-spike protein IgG antibodies, it did not elicit sufficient neutralizing antibodies levels. Conclusions The S-268019-a vaccine was not sufficiently immunogenic in Japanese adults despite robust immunogenicity and efficacy in mice. Our results exemplify the innate challenges in translating preclinical data in animals to clinical trials, and highlight the need for continued research to overcome such barriers. (jRCT2051200092)

7.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-2159910

ABSTRACT

As novel SARS-CoV-2 Variants of Concern emerge, the efficacy of existing vaccines against COVID-19 is declining. A possible solution to this problem lies in the development of a live attenuated vaccine potentially able of providing cross-protective activity against a wide range of SARS-CoV-2 antigenic variants. Cold-adapted (ca) SARS-CoV-2 variants, Dubrovka-ca-B4 (D-B4) and Dubrovka-ca-D2 (D-D2), were obtained after long-term passaging of the Dubrovka (D) strain in Vero cells at reduced temperatures. Virulence, immunogenicity, and protective activity of SARS-CoV-2 variants were evaluated in experiments on intranasal infection of Syrian golden hamsters (Mesocricetus auratus). In animal model infecting with ca variants, the absence of body weight loss, the significantly lower viral titer and viral RNA concentration in animal tissues, the less pronounced inflammatory lesions in animal lungs as compared with the D strain indicated the reduced virulence of the virus variant. Single intranasal immunization with D-B4 and D-D2 variants induced the production of neutralizing antibodies in hamsters and protected them from infection with the D strain and the development of severe pneumonia. It was shown that for ca SARS-CoV-2 variants, the temperature-sensitive (ts) phenotype was not obligate for virulence reduction. Indeed, the D-B4 variant, which did not possess the ts phenotype but had lost the ability to infect human lung cells Calu-3, exhibited reduced virulence in hamsters. Consequently, the potential phenotypic markers of attenuation of ca SARS-CoV-2 variants are the ca phenotype, the ts phenotype, and the change in species specificity of the virus. This study demonstrates the great potential of SARS-CoV-2 cold adaptation as a strategy to develop a live attenuated COVID-19 vaccine.

8.
Journal of the Formosan Medical Association ; 2022.
Article in English | ScienceDirect | ID: covidwho-2159259

ABSTRACT

Background Studies correlating reactogenicity and immunogenicity of COVID-19 vaccines are limited to BNT162b2, with inconsistent results. We investigated whether adverse reactions after other COVID-19 vaccines reliably predict humoral responses. Methods Adult volunteers were recruited for homologous or heterologous prime-boost vaccinations with adenoviral (ChAdOx1, AstraZeneca) and/or mRNA (mRNA-1273, Moderna) vaccines administered either 4 or 8 weeks apart. Adverse effects were routinely solicited and recorded by subjects in a standard diary card for up to 84 days post booster vaccination. Anti-SARS-CoV-2 IgG titers were measured pre- (visit 1), and post-booster dose at days 14 (visit 2) and 28 (visit 3). Results A total of 399 participants (75% women) with a median age of 41 (interquartile range, 33-48 IQR) years were included. Vaccine-induced antibody titers at days 14 and 28 were significantly higher among subjects who reported local erythema, swelling, pain, as well as systemic fever, chills, headache, myalgia, arthralgia, fatigue compared to those who did not experience local or systemic reactogenicity. Post-vaccination humoral responses did not correlate with the occurrence of skin rash and correlated weakly with gastrointestinal symptoms. A significant correlation between post-vaccination peak body temperature and anti-SARS-CoV-2 spike IgG at Day 14, independent of vaccine type and schedule, was found. Conclusions Specific symptoms of reactogenicity such as post-vaccination injection site pain, swelling, erythema and fever, myalgia and fatigue are significantly predictive of the magnitude of the anti-SARS-CoV-2 antibody response.

10.
Clinical Microbiology and Infection ; 2022.
Article in English | ScienceDirect | ID: covidwho-2149568

ABSTRACT

Background Solid organ transplant (SOT) recipients have increased morbidity and mortality risk from coronavirus disease 2019 (COVID-19). Objectives This study aimed to evaluate the immunogenicity of COVID-19 vaccines in SOT recipients. Data sources Electronic databases were searched for eligible reports published from December 1, 2019 to May 31, 2022. Study eligibility criteria We included reports evaluating the humoral immune response (HIR) or cellular immune response (CIR) rate in SOT recipients after COVID-19 vaccines. Participants SOT recipients who received COVID-19 vaccines. Assessment of risk of bias We used the Newcastle-Ottawa Scale to assess bias in case-control and cohort studies. For the randomized controlled trials, the Jadad Scale was used. Methods of data synthesis We used a random-effects model to calculate the pooled rates of immune response with 95% confidence intervals (CI). We used a risk ratio (RR) with 95% CI for a comparison of immune responses between SOT and healthy controls. Results A total of 91 reports involving 11,886 transplant recipients (lung: 655, heart: 539, liver: 1,946 and kidney: 8,746) and 2,125 healthy controls revealed pooled HIR rates after the 1st, 2nd, and 3rd COVID-19 vaccine doses in SOT recipients were 9.5% (95% CI: 7%-11.9%), 43.6% (95% CI: 39.3%-47.8%) and 55.1% (95% CI: 44.7%-65.6%), respectively. For specific organs, the HIR rates were still low after 1st dose vaccination (lung: 4.4%;kidney: 9.4%;heart: 13.2%;liver: 29.5%) and 2nd dose(lung: 28.4%;kidney: 37.6%;heart: 50.3%;liver: 64.5%). Conclusion A booster vaccination enhances the immunogenicity of COVID-19 vaccines in SOT, however, a significant share of the recipients still has not built a detectable HIR after the 3rd dose. This finding calls for alternative approaches, including the use of monoclonal antibodies. In addition, lung transplant recipients need urgent booster vaccination to improve the immune response.

11.
Immunological Reviews ; 310(1):4-92, 2022.
Article in English | GIM | ID: covidwho-2124384

ABSTRACT

This special issue includes 6 articles that discuss correlates of protection against SARS-CoV-2 infection and COVID-19 disease;immunological memory to SARS-CoV-2 infection and COVID-19 vaccines;immunogenicity and efficacy of Ad26.COV2.S: An adenoviral vector-based COVID-19 vaccine;leveraging South African HIV research to define SARS-CoV-2 immunity triggered by sequential variants of concern;protective neutralizing epitopes in SARS-CoV-2.

12.
Front Immunol ; 13: 1017590, 2022.
Article in English | MEDLINE | ID: covidwho-2142027

ABSTRACT

Background: In response to SARS-CoV-2 mutations and waning antibody levels after two-dose inactivated vaccines, we assessed whether a third dose of recombinant protein subunit vaccine (ZF2001) boosts immune responses. Methods: An open-label single-center non-random trial was conducted on people aged 18 years and above at five sites in China. All participants received a two-dose inactivated vaccine (CoronaVac) as their prime doses within 3-9 months of the trial. Primary outcomes were safety and immunogenicity, primarily the geometric mean titers (GMTs) of neutralizing antibodies to live wildtype SARS-CoV-2. Results: A total of 480 participants (median age, 51; range 21-84 years) previously vaccinated with two-dose CoronaVac received a third booster dose of ZF2001 3-4, 5-6, or 7-9-months later. The overall incidence of adverse reactions within 30 days after vaccination was 5.83% (28/480). No serious adverse reactions were reported after the third dose of ZF2001. GMTs in the 3-4-, 5-6-, and 7-9-month groups before vaccination were 3.96, 4.60, and 3.78, respectively. On Day 14, GMTs increased to 33.06, 47.51, and 44.12, respectively. After the booster, GMTs showed no significant difference among the three prime-boost interval groups (all P>0.05). Additionally, GMTs in older adults were lower than those in younger adults on Day 14 for the three groups (P=0.0005, P<0.0001, and P<0.0001). Conclusion: Heterologous boosting with ZF2001 was safe and immunogenic, and prime-boost intervals did not affect the immune response. The immune response was weaker in older than younger adults.


Subject(s)
COVID-19 Vaccines , COVID-19 , Aged , Humans , Middle Aged , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Protein Subunits , SARS-CoV-2 , Vaccines, Inactivated/administration & dosage , Vaccines, Subunit/adverse effects , Vaccines, Synthetic/adverse effects , Young Adult , Adult , Aged, 80 and over
13.
Front Immunol ; 13: 1017232, 2022.
Article in English | MEDLINE | ID: covidwho-2142026

ABSTRACT

Introduction: Fibrodysplasia ossificans progressiva (FOP) is characterized by progressive heterotopic ossification triggered by various conditions, such as trauma, infection, including COVID-19 infection, and vaccination. Although SARS-CoV-2 vaccinations prevent poor outcomes in the general population, there is limited evidence on safety, immunogenicity, and efficacy of SARS-CoV-2 vaccines for inpatients with FOP. Methods: A case series of two patients with FOP focused on humoral, cellular post-vaccination response, and the incidence of adverse events after administration of the BNT162b2 vaccine (Comirnaty). Results: Injection site reactions, fever, myalgia, and fatigue were the most common adverse events (AE). Neither severe AE (SAE), nor disease flare-ups were observed. No differences between patients with FOP and healthy controls were observed in humoral and cellular responses. Conclusions: The BNT162b2 vaccine induced high humoral and cellular response levels in patients with FOP. Vaccination was not associated with SAE or disease relapse. The AEs spectrum was comparable to that of the general population.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myositis Ossificans , Vaccines , Humans , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , Immunity, Cellular , SARS-CoV-2
14.
Front Immunol ; 13: 981693, 2022.
Article in English | MEDLINE | ID: covidwho-2142011

ABSTRACT

Objectives: Emergence of new variants of SARS-CoV-2 might affect vaccine efficacy. Therefore, assessing the capacity of sera to neutralize variants of concern (VOCs) in BSL-2 conditions will help evaluating the immune status of population following vaccination or infection. Methods: Pseudotyped viruses bearing SARS-CoV-2 spike protein from Wuhan-Hu-1/D614G strains (wild type, WT), B.1.617.2 (Delta), or B.1.1.529 (Omicron) VOCs were generated to assess the neutralizing antibodies (nAbs) activity by a pseudovirus-based neutralization assay (PVNA). PVNA performance was assessed in comparison to the micro-neutralization test (MNT) based on live viruses. Sera collected from COVID-19 convalescents and vaccinees receiving mRNA (BNT16b2 or mRNA-1273) or viral vector (AZD1222 or Ad26.COV2.S) vaccines were used to measure nAbs elicited by two-dose BNT16b2, mRNA-1273, AZD1222 or one-dose Ad26.CO2.S, at different times from completed vaccination, ~ 1.5 month and ~ 4-6 months. Sera from pre-pandemic and unvaccinated individuals were analyzed as controls. Neutralizing activity following booster vaccinations against VOCs was also determined. Results: PVNA titers correlated with the gold standard MNT assay, validating the reliability of PVNA. Sera analyzed late from the second dose showed a reduced neutralization activity compared to sera collected earlier. Ad26.CO2.S vaccination led to very low or absent nAbs. Neutralization of Delta and Omicron BA.1 VOCs showed significant reduction of nAbs respect to WT strain. Importantly, booster doses enhanced Omicron BA.1 nAbs, with persistent levels at 3 months from boosting. Conclusions: PVNA is a reliable tool for assessing anti-SARS-CoV-2 nAbs helping the establishment of a correlate of protection and the management of vaccination strategies.


Subject(s)
COVID-19 , RNA Viruses , Ad26COVS1 , Antibodies, Neutralizing , COVID-19/prevention & control , Carbon Dioxide , ChAdOx1 nCoV-19 , Humans , Membrane Glycoproteins/metabolism , RNA, Messenger , Reproducibility of Results , SARS-CoV-2/genetics , Spike Glycoprotein, Coronavirus , Viral Envelope Proteins
15.
Yonsei Med J ; 63(12): 1078-1087, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2141689

ABSTRACT

PURPOSE: The association between reactogenicity and immunogenicity of the ChAdOx1 nCOV-19 is controversial. We aimed to evaluate this association among South Korean healthcare workers (HCWs). MATERIALS AND METHODS: Participants received two doses of the ChAdOx1vaccine 12 weeks apart. Blood samples were tested for anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) spike protein receptor binding domain antibodies about 2 months after the first and second doses using the Elecsys Anti-SARS-CoV-2 S assay kits. Adverse events were noted using an online self-reporting questionnaire. RESULTS: Among the 232 HCWs, pain (85.78% after the first dose vs. 58.62% after the second dose, p<0.001) was the most prominent local reaction, and myalgia or fatigue (84.05% vs. 53.02%, p<0.001) was the most prominent systemic reaction. The frequency of all adverse events was significantly reduced after the second dose. After the first dose, the anti-SARS-CoV-2 S showed significantly higher titer in the group with swelling, itching, fever, and nausea. Also, the anti-SARS-CoV-2 S titer significantly increased as the grade of fever (p=0.007) and duration of fever (p=0.026) increased; however, there was no significant correlation between immunogenicity and adverse event after the second dose. The group with pain after the first dose showed a greater increase in the anti-SARS-CoV-2 S difference between the second and first doses compared to the group without pain (542.2 U/mL vs. 363.8 U/mL, p=0.037). CONCLUSION: The frequency of adverse events occurring after the first dose of the ChAdOx1 was significantly reduced after the second dose. Interestingly, the elevation of anti-SARS-CoV-2 S titer was significantly increased in the group with pain after the first dose.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , COVID-19/prevention & control , SARS-CoV-2 , Health Personnel , Fever , Pain/etiology , Antibodies , Republic of Korea
16.
Virol J ; 19(1): 174, 2022 11 01.
Article in English | MEDLINE | ID: covidwho-2139345

ABSTRACT

Since its discovery in the 1990s, the DNA vaccine has been of great interest because of its ability to elicit both humoral and cellular immune responses while showing relative advantages regarding producibility, stability and storage. However, when applied to human subjects, inadequate immunogenicity remains as the greatest challenge for the practical use of DNA vaccines. In this study, we generated a DNA vaccine Δ42PD1-P24 encoding a fusion protein comprised of the HIV-1 Gag p24 antigen and the extracellular domain of murine Δ42PD1, a novel endogenous Toll-like receptor 4 (TLR4) agonist. Using a mouse model, we found that Δ42PD1-P24 DNA vaccine elicited a higher antibody response and an increased number of IFN-γ-producing CD4 and CD8 T cells. Moreover, mice with Δ42PD1-P24 DNA vaccination were protected from a subcutaneous challenge with murine mesothelioma cells expressing the HIV-1 p24 antigen. Importantly, the Δ42PD1-mediated enhancement of immune responses was not observed in TLR4 knockout mice. Collectively, these data demonstrate that the immunogenicity and efficacy of DNA vaccines could be improved by the fusion of the extracellular domain of Δ42PD1 to target the immunogen to dendritic cells.


Subject(s)
AIDS Vaccines , HIV Infections , HIV-1 , Vaccines, DNA , Animals , Mice , Humans , HIV-1/genetics , Toll-Like Receptor 4 , CD8-Positive T-Lymphocytes , Immunity, Cellular , HIV Core Protein p24
17.
Curr Pain Headache Rep ; 2022 Nov 23.
Article in English | MEDLINE | ID: covidwho-2129141

ABSTRACT

PURPOSE OF REVIEW: The aim of this review is to characterize headache as a vaccine adverse event (VAE) in clinical trials. RECENT FINDINGS: Of the recent phase III vaccine RCTs (non-COVID-19), 53 studies reported on headache (13 infectious agents). The median rate (interquartile range) of headache was 15.6% (IQR: 9.6-37.6%). Of these, 24.5% of the RCTs reported headache greater in the vaccine group compared to the placebo/control group. In the herpes zoster vaccination trials, headache was more common in all active groups: median rate 33.9% (IQR: 29.7-40.5%) as compared to placebo: median rate 17.7% (IQR: 15.4-23.8%). Influenza and HPV vaccination trials were the 2nd and 3rd most common to have headache as a VAE. Of the 6 widely distributed COVID-19 vaccinations, median rate of post-vaccination headache was 39% (IQR: 28-50%). Headache is a common VAE in vaccine trials. Standardized grading methods, predictors of persistence, and treatment regimens are warranted.

18.
Revue Medicale Suisse ; 17(733):690-696, 2021.
Article in French | EMBASE | ID: covidwho-2146896

ABSTRACT

Many vaccine strategies have been developed to control the COVID-19 pandemic. This article presents the mechanisms of action and the efficacy of different vaccines including mRNA- and adenovirus-based vaccines. We will discuss the different vaccine targets, immune responses and allergic reactions which have been reported during the vaccination campaigns. Finally, the latest recommendations for the prevention and management of severe allergic reactions will be summarized. Copyright © 2021 Editions Medecine et Hygiene. All rights reserved.

19.
Multiple Sclerosis Journal ; 28(3 Supplement):104-105, 2022.
Article in English | EMBASE | ID: covidwho-2138838

ABSTRACT

Introduction: In patients with Multiple Sclerosis (pwMS) treated with anti-CD20 treatment or fingolimod it was observed a reduced humoral response after the second dose of mRNA-based SARS-CoV-2 vaccines.It is important to evaluate the effect of the third dose in these groups of patients. Aim(s): To describe the demographical and clinical characteristics of pwMS which received the third dose of Covid-19 vaccine and compare within patients the antibody levels measured just before the third dose with the same assessment executed one month after the third dose. Method(s): The CovaXiMS study is a prospective study for the evaluation of immunogenicity of anti-SARS-CoV2 vaccines in pwMS. Adult pwMS who have performed a third dose of SARSCoVv- 2 vaccination were included in the study. The main endpoint is the change in the antibody levels from six months after the second dose vs one month following the third dose, by considering actual DMTs. Result(s): Out of 1881 enrolled pwMS, 318 (16.9%) received the third dose (83.6% mRNA BNT162b2 and 16.4%mRNA-1273) with a complete assessment of antibody levels before and after the injection. Of them, 236 (74.2%) were females, with a mean age of 48.1 (SD:12.43). Median EDSS was 2.0 [IQR: 1.0-3.5], 8 (2.5%) pwMS recorded at least one relapse in the three months before enrollment, 271 (85.2%) were RRMS, 27 (8.5%) SPMS, and 20 (6.3%) PPMS. Fifty-six (17.6%) pwMS were on fingolimond, 52 (16.4%) on anti-CD20, and 210 (66.0%) on other drugs. Median antibody level (BAU/ml) measured just before the third dose was: 0.0 for pwMS treated with anti-CD20, 35.7 for pwMS on fingolimod and 680.9 for pwMS with other therapies. One month after the third dose the median change in the antidoby levels (BAU/ml) was: +0.6 for pwMS on anti-CD20, +694.6 for pwMS on fingolimod and +13879.4 BAU/ml for pwMS on other DMTs (p<0.001). Considering 659 BAU/mL as the best cut-off indicating a protective antibody level, as suggested by previous literature, 98% of pwMS on other DMTs showed a value above this value, 55% of pwMS on fingolimod, and 23% of pwMS on anti-CD20 (p<0.001). Conclusion(s): After the third dose, a significant increase in antidoby levels was detected in patients with MS. Patients in fingolimod and anti-CD20 had an increase significantly lower than patients in other drugs, but 55% of patients on fingolimod reached an antibody level considered as protective.

20.
Multiple Sclerosis Journal ; 28(3 Supplement):780, 2022.
Article in English | EMBASE | ID: covidwho-2138775

ABSTRACT

Introduction/Objectives: Immunity after two doses of inactivated and messenger RNA(mRNA) SARS-CoV 2 vaccines in Multiple Sclerosis (MS) is influenced by the Disease-Modifying Therapy (DMT) and vaccine type used. Being lower in fingolimod, ocrelizumab, and inactivated vaccine groups. A booster dose could change this discrepancy. Aim(s): To compare the immunogenicity of a booster dose of mRNA BNT162b2 (Pfizer/BioNTech) versus inactivated vaccine, performed after completing two doses of inactivated Coronavac in people with MS (pwMS). Method(s): pwMS and Healthy Controls (HC) who received a booster dose of SARS-CoV 2 mRNA or inactivated vaccine after completing two doses of inactivated Coronovac were enrolled in this single-center cross-sectional study. Serum samples were collected at least two weeks after the third dose of the vaccine. The antibody titers were compared between HC, MS, and each treatment group. Result(s): Each of 339 pwMS and 52 HC received three doses of SARS-CoV-2 vaccines. 283 (72,3%) participants received a booster dose of mRNA, and 108 (27,7%) participants received a booster dose of inactivated Coronavac. In all comparisons, patients treated with ocrelizumab had the lowest antibody titer (p<0.005). In the fingolimod group, booster mRNA caused a higher antibody titer than the inactivated vaccine. In total, pwMS had a lower antibody titer than HC regardless of the vaccine type. In regression analyses having a booster mRNA [beta= -0.671 (0.133) 95%CI= -0.933 - -0.409, p<0.001] and lower disease duration [beta-0.019 (0.010)95%CI= -0.038 - 0.000, p=0.44] were two markers which significantly associated with higher antibody titer in pwMS. Conclusion(s): The study shows that a third dose vaccine is an effective strategy to boost antibody response in the MS population, and the mRNA SARS CoV-2 vaccine's booster is preferable to inactivated ones.

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