Clinical and Experimental Vaccine Research
- Quarterly
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- 2287-3651(pISSN)
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- 2287-366X(eISSN)
Domain
- Health Sciences > Clinical Medicine
- Health Sciences > Development of Pharmaceutical
Aim & Scope
Clin Exp Vaccine Res, the official English journal of the Korean Vaccine Society, is an international, peer reviewed, and open-access journal. It covers all areas related to vaccines and vaccination. Clin Exp Vaccine Res publishes editorials, review articles, special articles, original articles, case reports, brief communications, and correspondences covering a wide range of clinical and experimental subjects including vaccines and vaccination for human and animals against infectious diseases caused by viruses, bacteria, parasites and tumor. The scope of the journal is to disseminate information that may contribute to elaborate vaccine development and vaccination strategies targeting infectious diseases and tumors in human and animals. Relevant topics range from experimental approaches to (pre)clinical trials for the vaccine research based on, but not limited to, basic laboratory, translational, and (pre)clinical investigations, epidemiology of infectious diseases and progression of all aspects in the health related issues. It is published printed and open accessed online issues (https://ecevr.org) two times per year in 31 January and 31 July. Clin Exp Vaccine Res is linked to many international databases and is made freely available to institutions and individuals worldwide.
KCI SCOPUSVolume 11 Issue 1
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Serdar Uzar;Fahriye Sarac;Veli Gulyaz;Hakan Enul;Huseyin Yilmaz;Nuri Turan 1
Purpose: Lumpy skin disease (LSD) is a highly contagious and economically important viral infection of cattle, which leads to financial losses in the livestock industry of affected countries. Vaccination is the most effective control measure to prevent the disease. Heterologous sheep pox (SP) vaccine was used against LSD in Turkey. In this research, it was aimed to adapt SP Bakırköy vaccine strain attenuated in lamb kidney cells to Madin-Darby bovine kidney (MDBK) cells to provide better protection than commercial SP vaccine in cattle. Materials and Methods: To evaluate safety and efficacy of vaccines, while animals were immunized with 10 doses (104.75 50% tissue culture infectious dose [TCID50]) and 5 doses of SP vaccine (104 TCID50) produced in MDBK cells, others were immunized with commercial Penpox-M vaccine (103.9 TCID50). Two cattle were kept as unvaccinated. At day 31 post-vaccination, all animals were challenged with the virulent LSD virus. Blood and swab samples were taken on certain days post-inoculation. Logarithmic differences challenge virus titers between vaccinated and unvaccinated animals were calculated. Results: The clinical sign was not observed in animals immunized with 10 doses of SP vaccine. The differences between the animals immunized with SP vaccine and control group was less than log 2.5 and the viremia occurred in immunized animals. The difference in titer was higher than log 2.5 in animals immunized with the Penpox-M, and viremia did not occur. Conclusion: SP vaccine strain propagated in MDBK cells and can be used for immunization to prevent LSD infections. However, SP vaccine strain propagated in MDBK showed poor protection as compared to Penpox-M. -
Shaimaa Abulmagd;Abd El-Nasser A. Khattab;Hamdallah Zedan 12
Purpose: In the present study, whole diphtheria toxin (dt) and fragment B (dtb) genes from Corynebacterium diphtheriae Park William were cloned into Escherichia coli, the purified expressed proteins were evaluated for ultimately using as a candidate vaccine. Materials and Methods: The dt and dtb genes were isolated from bacterial strain ATCC (American Type Culture Collection) no. 13812. Plasmid pET29a+ was extracted by DNA-spin TM plasmid purification kit where genes were inserted using BamHI and HindIII-HF. Cloned pET29a+dt and pET29a+dtb plasmids were transformed into E. coli BL21(DE3)PlysS as expression host. The identity of the sequences was validated by blasting the sequence (BLASTn) against all the reported nucleotide sequences in the NCBI (National Center for Biotechnology Information) GenBank. Production of proteins in high yield by different types and parameters of fermentation to determine optimal conditions. Lastly, the purified concentrated rdtx and rdtb were injected to BALB/c mice and antibody titers were detected. Results: The genetic transformation of E. coli DH5α and E. coli BL21 with the pET-29a(+) carrying the dt and dtb genes was confirmed by colony polymerase chain reaction assay and were positive to grow on Luria-Bertani/kanamycin medium. The open reading frame of dt and dtb sequences consisted of 1,600 bp and 1,000 bp, were found to be 100% identical to dt and dtb sequence of C. diphtheriae (accession number KX702999.1 and KX702993.1) respectively. The optimal condition for high cell density is fed-batch fermentation production to express the rdtx and rdtb at 280 and 240 Lf/mL, dissolved oxygen was about 24% and 22% and the dry cell weight of bacteria was 2.41 g/L and 2.18 g/L, respectively. Conclusion: This study concluded with success in preparing genetically modified two strains for the production of a diphtheria vaccine, and to reach ideal production conditions to achieve the highest productivity. -
Hamed Adel Elhelw;Maha Raafat Abd el Fadeel;Elham El-Sergany;Ahmad Allam;Mohamed Karam Elbayoumy;Adel Mahrous El-Kattan;Alaa Abdel-Moneim El-kholy 30
Purpose: The key objective of this study was to formulate a local combined inactivated gel adjuvanted vaccine containing bovine viral diarrhea virus (BVDV)-1, BVDV-2 viruses and Clostridium perfringens type A toxoid. The study evaluated its ability to enhance protective active immune response in camels' calves against these infectious pathogens under field conditions. Materials and Methods: The local BVDV cytopathic strains and a local strain of toxigenic C. perfringens type A were used in vaccines formulation. Vaccines A and B were monovalent vaccines against C. perfringens and both strains of BVDVs, respectively. While the vaccine C was the combined vaccine used against the three agents. All vaccines were adjuvanted with Montanide gel. Sterility, safety, and potency tests were applied on the formulated vaccines. Virus neutralization and toxin anti-toxin neutralization tests were used to evaluate the immune responses. Results: Both monovalent (vaccine A) and combined vaccines (vaccine C) showed a protective level (4.5 and 3 IU/mL, respectively) against C. perfringens from the 2nd-week post-vaccination. The titer declined to 3 and 2 IU/mL, respectively at the 5th-month post-vaccination. The titer against BVDV, the monovalent vaccine (vaccine B) reached the beak (1.95 IU/mL) at the 1st-month post-vaccination and lasted till 6th-month post-vaccination (0.92 and 0.94 IU/mL) for BVDV-1a and BVDV-2, respectively. Conclusion: Vaccination of camels with the combined vaccine adjuvanted by Montanide gel containing C. perfringens type A toxoid and BVDV strains with 6-month intervals is recommended to protect camels safely and efficiently against such infections in the field. -
Yetty M. Nency;Farid Agung Rahmadi;Mulyono;Dimas Tri Anantyo;Nur Farhanah;Rebriarina Hapsari;Helmia Farida;Udadi Sadhana;Herry Djagat;Tri Nur Kristina;Achmad Zulfa Juniarto;Mita Puspita;Rini Mulia Sari;Novilia Sjafri Bachtiar 43
Purpose: Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine. Materials and Methods: An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject's safety was monitored for 28 days after each vaccination. Results: Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines. Conclusion: Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine. -
Ayman Al-Mariri;Laila Al-Hallab;Rasha Alabras;Heba Kherbik;Marwa Khawajkiah 53
Purpose: Brucella spp. is a zoonosis that causes undulant fever in humans and abortion in livestock worldwide. Lately, it was conveyed that vaccines developed by irradiation have induced a strong cellular and humoral immune response which have made these types of vaccines highly effective. Materials and Methods: In this study, we aimed to use the gamma-irradiated B. ovis as a vaccine and to study the humoral immune response and cytokines production in order to evaluate it for protecting mice against B. abortus 544, B. melitensis 16M, and B. ovis. Results: The humoral immune response in immunized mice with gamma-irradiated B. ovis showed a lasting for 8 weeks after immunization. Moreover, immunoglobulin G (IgG), IgG1, IgG2a, and IgG2b isotypes antibodies against B. ovis were observed after 4 and 8 weeks of the last immunization. It was noticed that the production of tumor necrosis factor-α, interferon-γ, and interleukin (IL)-10 continued after 4 and 8 weeks by splenocytes from immunized BALB/c mice, while no production of IL-4 or IL-5 was observed. Conclusion: Our results indicate that the protection of BALB/c mice against B. melitensis 16M, B. abortus 544, and B. ovis was induced and the developed vaccine at our laboratory could stimulate similar protection to those induced by the traditional vaccine. -
Sreshtha Chowdhury;Rifat Ara;Simanta Roy;Syed Md. Sayeem Tanvir;Fahima Nasrin Eva;Tasnova Mehrin Neela;Amena Akter Moonmoon;Shamma Sifat;Mushfera Zamila;Mohammad Delwer Hossain Hawlader 63
Purpose: Sexually transmitted infections are a major worldwide concern, and human papillomavirus (HPV) is one of the significant risk factors. Many populations suffer from various diseases caused by HPV, and the overall death toll due to cervical carcinoma is remarkable. Despite vaccine availability, perception about vaccine safety and efficacy, its' preventive outcome is still inferior among the health professionals and vaccine providers. So, this study aims to assess the knowledge, attitude, and practice level of HPV and its' vaccination among doctors, dentists, and medical students. Materials and Methods: This cross-sectional survey was carried out between April to August 2021, where 626 participants from all types of medical institutions of Bangladesh were interviewed using a validated and structured questionnaire that consists of four extensive areas; socio-demographic characteristics, HPV knowledge, attitude, and practices regarding vaccination. Results: The knowledge and practice standards showed very poor outcomes where 43.29% of the participants showed good knowledge and only 11.82% conveyed good practices. Nevertheless, the attitude towards HPV vaccination was revealed high (75.88%). Female participants showed more positive attitudes than males. Conclusion: Physicians and dentists play vital roles in raising public knowledge about HPV and awareness regarding HPV vaccination programs. The provision of medical education on HPV must be prioritized, and current training techniques must be re-evaluated. Thus, by implementing this strategy, improvement in national vaccination policy can be expected. -
Doracelly Hincapie-Palacio;Adriana Echeverri;Cristina Hoyos;Felipe Vargas-Restrepo;Marta Ospina;Seti Buitrago;Jesus Ocho 72
Purpose: This study aims to compare protection against diphtheria and tetanus conferred on the mother and the neonate before and after maternal vaccination against tetanus, diphtheria, and acellular pertussis (Tdap), transfer of antibodies, and the variables that could impact on the protection. Materials and Methods: The study followed a cohort of 200 pregnant women from a region in Colombia, contacted during prenatal control before vaccination and upon delivery. The work determined immunoglobulin G antibodies against diphtheria and tetanus of pregnant women and umbilical cord. The proportion of protection, the geometric mean of the concentration, and the transfer of maternal antibodies were calculated. The protection profile of the pregnant women was explored by using multiple correspondence analysis. Results: The concentration of antibodies against diphtheria was significant before and after vaccination of the pregnant women (p=0.000) with proportions of 85.0% and 97.5%, respectively, and of 98.6% in the umbilical cord, with significant antibody correlation (Spearman's coefficient=0.668, p=0.01). Sero-protection against tetanus before vaccination was at 71.0%, after at 92.6%, and in the umbilical cord at 95.9%, with significant antibody concentration before and after vaccination (p=0.000) and antibody correlation (Spearman's coefficient=0.936, p=0.01). Sero-protection was higher when the pregnant women were vaccine 8 to 11 weeks before delivery. Unprotected pregnant women were those not vaccinated during pregnancy. Conclusion: The high proportion of protection against diphtheria and tetanus and the placental transfer support the need to promote maternal immunization with Tdap. -
Emmanuel Lamptey;Ephraim Kumi Senkyire;Dooshima Aki Benita;Evans Osei Boakye 82
Following the development of the coronavirus disease 2019 (COVID-19) vaccines and the launching of vaccination, the World Health Organization has reported that the African Continent is lagging in the race to vaccinate its population against the deadly virus. The Continent has received a limited number of vaccines, implying that vaccine production needs to be scaled up in Africa. In this review, we summarize the current situation concerning COVID-19 vaccine development in Africa, progress made, challenges faced in vaccine development over the years and potential strategies that will harness vaccine production success. -
Johan Wibowo;Rivaldo Steven Heriyanto;Felix Wijovi;Devina Adella Halim;Claudia Claudia;Elizabeth Marcella;Billy Susanto;Michele Indrawan;Nadia Khoirunnisa Heryadi;Michelle Imanuelly;Jonathan Juniard Anurantha;Timotius Ivan Hariyanto;Chintya Marcellin;Terry Devita Sinaga;Saraswati Anindita Rizki;Novia Sieto;Jeremia Immanuel Siregar;Nata Pratama Hardjo Lugito;Andree Kurniawan 89
Purpose: As coronavirus disease 2019 (COVID-19) continues to spread rapidly causing approximately 186 million confirmed cases around the world, the urgency to reach herd immunity through vaccination is increasing. However, vaccine safety is a top priority to limit the occurrence of adverse events. Henceforth, this study aims to recognize and perceive COVID-19 vaccine safety in Indonesia during the pandemic. Materials and Methods: This is a cross-sectional study and was conducted in Indonesia during the COVID-19 pandemic using an online survey of demographic information and a qualitative questionnaire. Responses were recorded and the association between demographic characteristics from survey questions was tested using chi-square with a risk estimate and 95% confidence interval. Results: A total of 311 participants from 33 out of 34 provinces in Indonesia participated in this study. Recorded responses showed multiple side effects of the COVID-19 vaccine both short-and long-term experienced by the participants. Significant associations were found between demographic factors and COVID-19 vaccine side effects such as female gender with short-term puncture site (odds ratio [OR], 0.463; 95% confidence interval [CI], 0.263-0.816) and short-term other reactions (OR, 0.463; 95% CI, 0.263-0.816), domicile outside Java island with long-term puncture site (OR, 4.219; 95% CI, 1.401-12.701) and immune reactions (OR, 3.375; 95% CI, 1.356-8.398), also between married marital status and long-term vagal reaction (OR, 4.655; 95% CI, 1.321-16.409). Conclusion: Gender, domicile and marital status factors were associated with COVID-19 vaccine side effects in Indonesian people. -
Alexander Kruttgen;Gerhard Haase;Helga Haefner;Matthias Imohl;Michael Kleines 96
Purpose: Studies on the immune responses to severe acute respiratory syndrome coronavirus 2 vaccines are necessary to evaluate the ongoing vaccination programs by correlating serological response data and clinical effectiveness data. We performed a longitudinal immunological profiling of health care workers vaccinated with mRNA-1273 (Moderna, Cambridge, MA, USA). Half of these vaccinees had experienced a mild coronavirus disease 2019 (COVID-19) infection in the spring of 2020 ("COVID-recovered" cohort), whereas the other half of the vaccinees had no previous COVID-19 infection ("COVID-naive" cohort). Materials and Methods: Serum was drawn at multiple time points and subjected to assays measuring anti-Spike immunoglobulin G (IgG), avidity of anti-Spike IgG, avidity of anti-receptor binding domain (RBD) IgG, virus neutralizing activity, and interferon-γ release from stimulated lymphocytes. Results: Between both cohorts and within each cohort, we found remarkable inter-individual differences regarding cellular and humoral immune responses to the Moderna mRNA-1273 vaccine. Conclusion: First, our study indicates that the success of mRNA-1273 vaccinations should be verified by serological assays in order to identify "low-responders" to vaccination. Second, the kinetics of anti-S IgG and neutralizing activity correlate well with clinical effectiveness data, thus explaining incipient protection against infection 2 weeks after the first dose of mRNA-1273 in COVID-naive vaccinees. Third, our IgG-avidity data indicate that this incipient protection is mediated by low-avidity anti-RBD IgG and low-avidity anti-S IgG. -
Adekunle Sanyaolu;Aleksandra Marinkovic;Stephanie Prakash;Priyank Desai;Nafees Haider;Abu Fahad Abbasi;Nasima Mehraban;Isha Jain;Amarachi Ekeh;Omar Shazley;Chuku Okorie;Verner N. Orish 104
Purpose: In the United States, Pfizer-BioNTech, Moderna, and Janssen's coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States. Materials and Methods: We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis. Results: Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%). Conclusion: Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination. -
Juandy Jo;Astia Sanjaya;Reinhard Pinontoan;Maroloan Aruan;Rury Mega Wahyuni;Venansi Viktaria 116
The immunogenicity of CoronaVac among Indonesian adults at the academic premises was investigated. Two doses of CoronaVac vaccine induced a complete seroconversion on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) naïve adults with titers of anti-SARS-CoV-2 receptor-binding domain (RBD) antibodies ranging from 9.1 to 151.9 U/mL. The median value was lower than the one observed in recovered adults with mild coronavirus disease 2019 (38.7 vs. 114.5 U/mL). Nonetheless, 93.6% of the vaccinated adults, in contrast to 76.5% of the recovered adults, displayed inhibition rates above the cut-off to block RBD-angiotensin-converting enzyme 2 binding. This suggests that two doses of CoronaVac were immunogenic and likely to be protective among Indonesian adults. -
Hanna Klingel;Maike Lauen;Alexander Kruttgen;Matthias Imohl;Michael Kleines 121
Knowledge about mRNA-1273 elicited T-cell response is limited. We investigated adverse reactions and interferon gamma release by specific T-cells among mRNA-1273 vaccinated health care workers. Seven to 13 weeks after complete vaccination low levels of specific T-cells were detected not correlating with antibody response. Severity of symptoms after first and number of symptoms after second immunization were associated with T-cell response. Assessment of T-cell response in addition to antibody response is crucial because even few specific T-cells could add to protection against infection. Investigation of mRNA-1273 induced inflammatory processes might help improve reactogenicity and immunogenicity. -
Post-vaccination side effects of AstraZeneca (AZ) coronavirus disease 2019 (COVID-19) vaccine are common. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection immediately after the first dose of AZ COVID-19 vaccine has not been reported. In this case, a 30-year-old female without a past medical history of SARS-CoV2 infection presented to an outpatient clinic with lightheadedness and weakness 2 hours after getting the first dose of the AZ COVID-19 vaccine. Blood pressure (BP) was 80/60 mm Hg, and oxygen saturation (SpO2) was 98%. After administering normal saline intravenous fluid, the BP was 110/80 mm Hg. On the first day, fever (oral temperature of 39℃), sweating, dry cough, sore throat, and injection-site pain were presented. On the second day, diarrhea, productive cough, and hypotension occurred in addition to fever (oral temperature of 39.9℃). The fever did not stop and productive cough, change in smell, and fatigue were reported. SpO2 was 96%. On the third day, no abnormality of the spiral lung computed tomography and the positive reverse transcriptase-polymerase chain reaction (RT-PCR) test were reported. Simultaneously, two out of three members of the family became symptomatic on the second day and their RT-PCR tests were positive. Dexamethasone ampule, Cefixime tablet, Acetaminophen tablet, and Diphenhydramine syrup were prescribed. After a week, fever subsided and SpO2 was 98%. After 3 weeks of self-quarantine at home, her general condition improved. Despite the similarity between SARS-CoV2 infection signs and symptoms and AZ COVID-19 vaccine side effects, none of the approved vaccines contain the live virus that causes disease. Therefore, any unusual post-vaccination signs and symptoms should not be attributed to the vaccine itself and need to be considered for further evaluations and early actions in order to prevent the spread of the disease in society.
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Giuseppe Gallo;Luca Mastorino;Luca Tonella;Simone Ribero;Pietro Quaglino 129
The coronavirus disease 2019 (COVID-19) vaccines are authorized for use in numerous countries worldwide. Several cutaneous findings are reported after severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination. Here, we report the case of a patient with a rapid onset of alopecia areata immediately after receiving the second dose of the COVID-19 vaccine. Alopecia areata is a common autoimmune disease leading to non-scarring hair loss. Among the many cutaneous adverse effects reported after the anti-SARS-COV2 vaccination, no episodes of alopecia areata have been described to date. In this paper, we report the first case of alopecia areata after COVID-19 vaccination described in the literature with a revision of cases of alopecia areata reported after other types of vaccination. Although the significance of these skin reactions is not yet known, further studies will certainly clarify whether the development of alopecia areata or other forms of immune-mediated reactions could represent a positive prognostic factor regarding immune protection from SARS-CoV-2.