Rabies Virus Neutralizing Activity, Safety, and Immunogenicity of Recombinant Human Rabies Antibody Compared with Human Rabies Immunoglobulin in Healthy Adults.

Objective: Preliminary assessment of rabies virus neutralizing activity, safety and immunogenicity of a recombinant human rabies antibody (NM57) compared with human rabies immunoglobulin (HRIG) in Chinese healthy adults. Methods: Subjects were randomly (1:1:1) allocated to Groups A (20 IU/kg NM57), B (40 IU/kg NM57), or C (20 IU/kg HRIG). One injection was given on the day of enrollment. Blood samples were collected on days -7 to 0 (pre-injection), 3, 7, 14, 28, and 42. Adverse events (AEs) and serious AEs (SAEs) were recorded over a period of 42 days after injection. Results: All 60 subjects developed detectable rabies virus neutralizing antibodies (RVNAs) (> 0.05 IU/mL) on days 3, 7, 14, 28, and 42. The RVNA levels peaked on day 3 in all three groups, with a geometric mean concentration (GMC) of 0.2139 IU/mL in Group A, 0.3660 IU/mL in Group B, and 0.1994 IU/mL in Group C. At each follow-up point, the GMC in Group B was significantly higher than that in Groups A and C. The areas under the antibody concentration curve over 0-14 days and 0-42 days in Group B were significantly larger than those in Groups A and C. Fifteen AEs were reported. Except for one grade 2 myalgia in Group C, the other 14 were all grade 1. No SAEs were observed. Conclusion: The rabies virus neutralizing activity of 40 IU/kg NM57 was superior to that of 20 IU/kg NM57 and 20 IU/kg HRIG, and the rabies virus neutralizing activity of 20 IU/kg NM57 and 20 IU/kg HRIG were similar. Safety was comparable between NM57 and HRIG.

Tumor Necrosis Factor-alpha Induced Protein 3 Interacting Protein 1 Gene Polymorphisms and Pustular Psoriasis in Chinese Han Population.

BACKGROUND: Psoriasis is a common immune-mediated inflammatory dermatosis. Generalized pustular psoriasis (GPP) is the severe and rare type of psoriasis. The association between tumor necrosis factor-alpha induced protein 3 interacting protein 1 (TNIP1) gene and psoriasis was confirmed in people with multiple ethnicities. This study was to investigate the association between TNIP1 gene polymorphisms and pustular psoriasis in Chinese Han population. METHODS: Seventy-three patients with GPP, 67 patients with palmoplantar pustulosis (PPP), and 476 healthy controls were collected from Chinese Han population. Six single nucleotide polymorphisms (SNPs) of the TNIP1 gene, namely rs3805435, rs3792798, rs3792797, rs869976, rs17728338, and rs999011 were genotyped by using polymerase chain reaction-ligase detection reaction. Statistical analyses were performed using the PLINK 1.07 package. Allele frequencies and genotyping frequencies for six SNPs were compared by using Chi-square test, odd ratio (OR) (including 95% confidence interval) were calculated. The haplotype analysis was conducted by Haploview software. RESULTS: The frequencies of alleles of five SNPs were significantly different between the GPP group and the control group (P ≤ 7.22 × 10-3), especially in the GPP patients without psoriasis vulgaris (PsV). In the haplotype analysis, the most significantly different haplotype was H4: ACGAAC, with 13.1% frequency in the GPP group but only 3.4% in the control group (OR = 4.16, P = 4.459 × 10-7). However, no significant difference in the allele frequencies was found between the PPP group and control group for each of the six SNPs (P > 0.05). CONCLUSIONS: Polymorphisms in TNIP1 are associated with GPP in Chinese Han population. However, no association with PPP was found. These findings suggest that TNIP1 might be a susceptibility gene for GPP.

Safety observation study on haemophilus influenza type B conjugate vaccines injected at different sites in Chinese infants.

In the present study, the safety of Haemophilus influenza type b conjugate vaccines inoculated in the upper arm deltoid and vastus lateralis muscle was evaluated. 680 infants aged 2-5 months and 6-12 months were selected to be the research subjects in whom the Hib conjugate vaccines were inoculated by injection in the upper arm deltoid and vastus lateralis muscle, respectively. The safety analysis indicated that there were no statistic differences in the incidence rates of adverse reactions when the Hib conjugate vaccines were inoculated at different sites. So we concluded that the safety of inoculation injection of Hib conjugate vaccines in vastus lateralis muscle was the same as that inoculated in the upper arm deltoid.

Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.

The 2009 influenza A(H1N1) pandemic strain was for the first time included in the 2010-2011 seasonal trivalent influenza vaccine (TIV). We conducted a double-blind, randomized trial in Chinese population to assess the immunogenicity and safety of the 2010-2011 TIV manufactured by GlaxoSmithKline and compared it with the counterpart vaccines manufactured by Sanofi Pasteur and Sinovac Biotech. Healthy toddlers (6-36 mo), children (6-12 y) and older adults (≥60 y) with 300 participants in each age group were enrolled to randomly receive two doses (toddlers, 28 d apart) or one dose (children and older adults). The immunogenicity was assessed by hemagglutination-inhibition (HI) assay. The solicited injection-site and systemic adverse events (AEs) were collected within 7 d after vaccination. All the three TIVs were well-tolerated with 15.1% of participants reporting AEs, most of which were mild. No serious AEs and unusual AEs were reported. Fever and pain were the most common systemic and injection-site AEs, respectively. The three TIVs showed good immunogenicity. The seroprotection rates against both H1N1 and H3N2 strains were more than 87% in toddlers after two doses and more than 95% in children and more than 86% in older adults after one dose. The seroprotection rates against B strain were 68-71% in toddlers after two doses, 70-74% in children and 69-72% in older adults after one dose. In conclusion, the three 2010-2011 TIVs had good immunogenicity and safety in Chinese toddlers, children and older adults and were generally comparable in immunogenicity and reactogenicity.

[Analysis of safety and effects on the oral whole cell/recombinant B subunit cholera vaccine in university students and workers].

OBJECTIVE: To evaluate the safety, immunogenicity and protective efficiency of the oral whole cell/recombinant B subunit cholera vaccine in Beijing Olympic volunteers and workers. METHOD: Analyzing the incidence rate of adverse reaction and Protective Rate (PR) after taking the vaccine in Olympic volunteers in 6 universities in Beijing; comparing the anti-cholera toxin (CT) detected with ELISA prior and after taking the vaccine in Olympic workers. RESULTS: The total rate of adverse reaction of Olympic volunteers was 0.38%; the main side effects were gastrointestinal symptoms, such as bellyache and diarrhea which were mild and temple; the acute diarrhea incidence rate of Olympic volunteers after taking the vaccine was significantly lower than those not taking it, the PR was 76.27%; the positive rate of anti-CT of Olympic workers after taking the vaccine was significantly higher than those before taking it, the levels of anti-CT titers declined after 6 months since they had taken the vaccine. CONCLUSION: The results from above two observed population indicate that the oral rBS-WC cholera vaccine is efficient and safe.

[Observation on two kinds of recombinant hepatitis B vaccines used in populations with different immunity].

OBJECTIVE: To evaluate the immunity status on different hepatitis B vaccines currently being used in Beijing. METHODS: College students who had not received hepatitis B vaccine and children who had received whole-course immunization at birth, were tested HBsAg, anti-HBs and anti-HBc. All the test-negative cases were served as research subjects. 3 doses recombinant hepatitis B vaccines were given to the college students, following the 0, 1, 6 months schedule. Among which, 140 cases received recombinant beer yeast hepatitis B vaccine (BY vaccine, 10 microg, 5 microg, 5 microg), and 140 cases with recombinant hansenula polymorpha hepatitis B vaccine (HP vaccine, 10 microg, 10 microg, 10 microg). 1 dose was given for boosting immunization to 98 children, in which 49 cases with BY vaccine (5 microg) and 49 cases with HP vaccine (10 microg). Anti-HBs was tested 1 month after. RESULTS: The total positive (> or = 10 mIU/ ml) rate was lower among BY vaccine group than HP vaccine group for the college students (93.5 %, 99.3% , P<0.05), but no statistical difference on GMT(81.2 mIU/ml, 94.6 mIU/ml, P>0.05) was found. For males, the positive rate and GMT were lower in BY vaccine group than in HP vaccine group (85.7% ,100.0%, P<0.01)(56.6 mIU/ml, 98.6 mIU/ml, P<0.01), but with no statistical difference for females (98.8%, 98.5%, P> 0.05) (103.4 mIU/ml, 90.3 mlU/ml, P> 0.05). For the same vaccine, the positive rate and GMT were lower in males than in females when using BY vaccine (85.7% , 98.8%, P<0.01)(56.6 mIU/ml,103.4 mIU/ml, P< 0.01), but no statistical difference was found on HP vaccine(100.0%, 98.5%, P>0.05)(98.6 mIU/ml, 90.3 mIU/ml, P>0.05). The positive rate of anti-HBs was decreasing along with age among the children who had received a whole-course immunization at birth (P <0.01). 98.6 % of the 70 negative cases appeared positive conversion after receiving 1 dose and the GMT raised significantly by 15 times. No statistical difference was found between the two kinds of vaccines(100.0%, 97.4%, P>0.05)(80.5 mIU/ml, 68.5 mIU/ml, P>0.05). CONCLUSIONS: The type of vaccine and sex were related to the effects, better with HP vaccine than BY vaccine in males but was the same for females in adults receiving basic immunization according to the conventional doses. Both kinds of vaccines were ideal when children receiving boosting immunization. The immune memory was good for persons who had received primary immunization with recombinant vaccine but antibody appeared negative conversion. It was not necessary to boost immunization within 6 years after a whole-course immunization with recombinant hepatitis B vaccine in infancy.