OBJECTIVES: This study aimed to observe the clinical and immune response characteristics of vaccinated persons infected with the delta variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Yangzhou, China. METHODS: We extracted the medical data of 129 patients with delta-variant infection who were admitted to Northern Jiangsu People's Hospital (Yangzhou, China) between August and September, 2021. The patients were grouped according to the number of vaccine doses received into an unvaccinated group: a one-dose group and a two-dose group. The vaccine used was SARS-CoV-2-inactivated vaccine developed by Sinovac. We retrospectively analyzed the patients' epidemiological, clinical, laboratory, and imaging data. RESULTS: Almost all patients with delta-variant infection in Yangzhou were elderly, and patients with severe/critical illness were over 70 years of age. The rates of severe/critical illness (P=0.006), fever (P=0.025), and dyspnea (P=0.045) were lower in the two-dose group than in the unvaccinated group. Compared to the unvaccinated group, the two-dose group showed significantly higher lymphocyte counts and significantly lower levels of C-reactive protein (CRP), interleukin-6 (IL-6), and D-dimer during hospitalization and a significantly higher positive rate of immunoglobulin G (IgG) antibodies at admission (all P<0.05). The cumulative probabilities of hospital discharge and negative virus conversion were also higher in the two-dose group than in the unvaccinated group (P<0.05). CONCLUSIONS Two doses of the SARS-CoV-2-inactivated vaccine were highly effective at limiting symptomatic disease and reducing immune response, while a single dose did not seem to be effective.
Aged ; Aged, 80 and over ; Humans ; COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Critical Illness ; Immunity ; Retrospective Studies ; SARS-CoV-2 ; Vaccines, Inactivated/adverse effects* ; Viral Vaccines/adverse effects*

BACKGROUND: The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults. METHODS: Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18 to 59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 or 10 μg/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 μg/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose. RESULTS: In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-μg vaccine (n = 24), 10-μg vaccine (n = 24), or placebo (n = 12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-μg vaccine (n = 100 for 0/14 or 0/28 regimens), 10-μg vaccine (n = 100 for each regimen), or placebo (n = 50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and seven (7/12) participants reported at least one adverse event (AE) after receiving 5-, 10-μg vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and nine (18%) 0/14-regimen participants reported at least one AE after receiving 5-, 10-μg vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine-unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses; 0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses. CONCLUSIONS: Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-μg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial. TRIAL REGISTRATION http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350; No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353).
Adult ; COVID-19 ; COVID-19 Vaccines ; Double-Blind Method ; Humans ; SARS-CoV-2 ; Vaccines, Inactivated/adverse effects*

BACKGROUND: Adjuvants used in inactivated vaccines often upregulate type 2 immunity, which is dominant in allergic diseases. We hypothesised that cumulative adjuvant exposure in infancy may influence the development of allergies later in life by changing the balance of type 1/type 2 immunity. We examined the relationship between immunisation with different vaccine types and later allergic disease development. METHODS: We obtained information regarding vaccinations and allergic diseases through questionnaires that were used in The Japan Environment and Children's Study (JECS), which is a nationwide, multicentre, prospective birth cohort study that included 103,099 pregnant women and their children. We examined potential associations between the initial vaccination before 6 months of age and symptoms related to allergies at 12 months of age. RESULTS: Our statistical analyses included 56,277 children. Physician-diagnosed asthma was associated with receiving three (aOR 1.395, 95% CI 1.028-1.893) or four to five different inactivated vaccines (aOR 1.544, 95% CI 1.149-2.075), compared with children who received only one inactivated vaccine. Similar results were found for two questionnaire-based symptoms, i.e. wheeze (aOR 1.238, 95% CI 1.094-1.401; three vaccines vs. a single vaccine) and eczema (aOR 1.144, 95% CI 1.007-1.299; four or five vaccines vs. a single vaccine). CONCLUSIONS: Our results, which should be cautiously interpreted, suggest that the prevalence of asthma, wheeze and eczema among children at 12 months of age might be related to the amount of inactivated vaccine exposure before 6 months of age. Future work should assess if this association is due to cumulative adjuvant exposure. Despite this possible association, we strongly support the global vaccination strategy and recommend that immunisations continue. TRIAL REGISTRATION UMIN000030786 .
Asthma ; epidemiology ; etiology ; Cohort Studies ; Dermatitis, Atopic ; epidemiology ; etiology ; Female ; Food Hypersensitivity ; epidemiology ; etiology ; Humans ; Hypersensitivity ; epidemiology ; etiology ; Infant ; Infant, Newborn ; Japan ; Male ; Vaccines, Inactivated ; adverse effects ; Viral Vaccines ; adverse effects

Objective: To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years, through a Meta-analysis. Methods: Literature was retrieved by searching the Medline, Cochrane Library, Science Direct in the past decade. All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV, versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64. Revman 5.3 software was employed to manipulate the pooled date of the included literature. Result: A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included. There appeared no significant differences in the response rates between the two vaccines. As for QIV versus TIV (B/Yamagata), the pooled RR of the SPR for B/Victoria was 1.28 (95%CI: 1.08-1.51, P<0.05), with the pooled RR of the SCR for B/Victoria as 1.94 (95%CI: 1.50-2.50, P<0.05). For QIV versus TIV (B/Victoria), the pooled RR of the SPR for B/Yamagata as 1.10 (95%CI: 1.02-1.18, P<0.05), and the pooled RR of SCR for B/Yamagata as 1.99 (95%CI: 1.34-2.97, P<0.05). Conclusion: In the population aged 18-64 years, inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.
Adolescent ; Adult ; Antibodies, Viral/blood* ; Drug-Related Side Effects and Adverse Reactions ; Hemagglutination Inhibition Tests ; Humans ; Influenza A virus/immunology* ; Influenza B virus/immunology* ; Influenza Vaccines/immunology* ; Influenza, Human/prevention & control* ; Middle Aged ; Vaccines, Inactivated/immunology* ; Young Adult

Although the overall incidence of hepatitis A in Korea has been decreasing, adolescents remain highly vulnerable to its outbreaks. This study was conducted to compare the immunogenicity and safety of three hepatitis A vaccines in Korean adolescents. Healthy anti-hepatitis A virus seronegative subjects aged 13 to 19 yr were randomized in three equal groups to receive two doses of Avaxim(TM), Epaxal(R), or Havrix(R), 6 to 12 months apart. Seroconversion rates one month after the first dose were 98%, 95%, and 93% for Avaxim(TM), Epaxal(R), and Havrix(R), respectively. Seroconversion rates reached 100% for all vaccine groups one month after the second dose. Anti-HAV geometric mean concentrations (GMCs) were 7,207.7 mIU/mL (95% CI, 6023.1-8684.7), 1,750.5 mIU/mL (95% CI, 1362.9-2248.3), and 1,953.5 mIU/mL (95% CI, 1459.4-2614.7) after two doses of Avaxim(TM), Epaxal(R), and Havrix(R) respectively. Avaxim(TM) was significantly more immunogenic than Epaxal(R) and Havrix(R), whereas there were no significant differences in antibody responses between Epaxal(R) and Havrix(R). Local and systemic solicited adverse events (AEs) were mostly of mild-to-moderate intensity and resolved within 5 days. No serious AEs were reported. In conclusion, all three vaccines are highly immunogenic and well-tolerated in Korean adolescents. (Clinical Trial Registry NCT00483470)
Adolescent ; Antibody Formation ; Female ; Hepatitis A/immunology/*prevention & control ; Hepatitis A Antibodies/blood ; Hepatitis A Vaccines/adverse effects/*immunology ; Humans ; Male ; Republic of Korea ; Vaccines, Inactivated/adverse effects/immunology ; Young Adult

OBJECTIVETo evaluate safety of different sequential immunization schedules of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) primary vaccination.

METHODSInfants of 2 months old (60-89 days) selected in Beijing, were assigned to four groups, 1 dose IPV plus 2 doses OPV (I-O-O), 2 doses IPV plus 1 dose OPV(I-I-O), 3 doses IPV (I-I-I), and 3 doses OPV (O-O-O), and were vaccinated at the age of 2, 3, 4 months, from 2009 to 2011. The frequencies of systemic as well as local injection site reactions after every dose were recorded and calculated. A total of 553 infants were enrolled in the study and 89 infants were quit, 1492 diseases were observed.

RESULTSThe incidence of adverse events in I-O-O, I-I-O, I-I-I, O-O-O were 22.9% (94/410), 18.4% (60/327), 22.0% (78/354) and 17.7% (71/401) with no statistical differences (χ(2) = 4.84, P = 0.184). Dose 1 (22.7% (32/141)-35.3% (54/153) ) was more frequently than dose 2 and dose 3. No serious adverse events (SAE) were reported during the study. The incidence of systemic adverse reactions in I-O-O, I-I-O, I-I-I, O-O-O were 21.5% (88/410), 17.7% (58/327) , 20.1% (71/354) and 17.7% (71/401) with no statistical differences (χ(2) = 2.53, P = 0.472). Abnormal crying were the most frequency reactions (7.2% (29/401)-11.3% (37/327) ) in 4 groups. Rarely severe reactions were observed of abnormal crying, somnolence, irritability and mild or medium reactions occurred in other symptoms. Local adverse reactions such as injection site pain, scleroma and swelling were reported by 2.2% (5/229)-5.6% (22/393) ,0-0.9% (2/229) and 0-1.0% (4/393) in I-O-O,I-I-O and I-I-I, and most reactions were mild.

CONCLUSIONThree IPV immunization and IPV/OPV sequential immunization as well as three OPV immunization demonstrated safe.

Humans ; Immunization Schedule ; Infant ; Poliovirus Vaccine, Inactivated ; administration & dosage ; adverse effects ; Vaccines, Attenuated ; administration & dosage ; adverse effects

We report results of a randomized, double-blinded, active-controlled, phase III study conducted to evaluate the immunogenicity and safety of a new trivalent inactivated split-virus influenza vaccine (GC501) manufactured by the Green Cross Corporation in Korea. A total of 283 healthy children aged 6 months to < 18 yr were randomized to receive either GC501 or control. Of the GC501 recipients, seroconversion occurred in 48.5% for A/H1N1, 67.7% for A/H3N2 and 52% for influenza B. The proportion of subjects who had post-vaccination hemagglutination-inhibition titers of 1:40 or greater was 90.7% for A/H1N1, 86.8% for A/H3N2 and 82.4% for influenza B in the GC501 recipients. No serious adverse events related to vaccination, or withdrawals because of adverse events were reported. The majority of solicited adverse events were mild in intensity. GC501 vaccine has good tolerability and favorable immunogenicity in children aged 6 months to < 18 yr. The addition of one more brand of influenza vaccine may allow for better global accessibility of vaccine for epidemics or future pandemics.
Adolescent ; Antibodies, Viral/*blood ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Humans ; Infant ; Influenza A Virus, H1N1 Subtype/*immunology ; Influenza A Virus, H3N2 Subtype/*immunology ; Influenza B virus/*immunology ; Influenza Vaccines/*adverse effects/*immunology ; Male ; Republic of Korea ; Vaccination ; Vaccines, Inactivated/adverse effects/immunology

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with > or = 80% of subjects achieving post-vaccination titers > or = 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Double-Blind Method ; Humans ; Influenza Vaccines/administration & dosage/*adverse effects/*immunology ; Influenza, Human/*prevention & control ; Male ; Middle Aged ; Republic of Korea ; Vaccination ; Vaccines, Inactivated/administration & dosage/adverse effects/immunology ; Young Adult

Child, Preschool ; China ; Female ; Hepatitis A ; immunology ; prevention & control ; Hepatitis A Antibodies ; blood ; Hepatitis A Vaccines ; adverse effects ; immunology ; Humans ; Infant ; Male ; Safety ; Sampling Studies ; Vaccination ; Vaccines, Inactivated ; adverse effects ; immunology

OBJECTIVETo evaluate the safety and immunogenicity of influenza split vaccine.

METHODSAccording to the criteria of No.2002SL0043, instruction of application for new drug in clinical trial issued by the State Food and Drug Administration, 876 healthy persons were divided at random into vaccine group and control group. The trial was performed with the double blind method. Local and systemic adverse reactions were observed within 3 days after the vaccine group subjects were vaccinated. The antibody response to vaccines was detected with hemagglutination inhibition (HI) test. Numbers of seroconversions and HI titers greater than or equal to 40, as well as the mean geometric titer increase in HI were analyzed.

RESULTSThere was no significant difference in local and systemic adverse reaction between vaccine and control groups. Meanwhile there was also no significant difference in seroconversions and protective level between two groups. However, there was obvious difference in mean geometric titer increase of antibody against H1N1 virus, while there was no significant difference in that of antibodies to H3N2 and type B viruses.

CONCLUSIONSThe safety and immunogenicity of both vaccines are excellent.

Adolescent ; Adult ; Aged ; Antibodies, Viral ; blood ; Child ; Child, Preschool ; Double-Blind Method ; Fever ; chemically induced ; Hemagglutination Inhibition Tests ; Humans ; Infant ; Influenza A virus ; immunology ; Influenza B virus ; immunology ; Influenza Vaccines ; adverse effects ; classification ; immunology ; Influenza, Human ; prevention & control ; Middle Aged ; Safety ; Vaccines, Inactivated ; adverse effects ; classification ; immunology