Immunogenicity of a Single Dose of Tetravalent Meningococcal Serogroups A, C, W-135, and Y Conjugate Vaccine Administered to 2- to 10-year-olds Is Noninferior to a Licensed-ACWY Polysaccharide Vaccine With an Acceptable Safety Profile

2011 ◽  
Vol 30 (4) ◽  
pp. e56-e62 ◽  
Author(s):  
Ziad A. Memish ◽  
Ghassan Dbaibo ◽  
May Montellano ◽  
Valsan P. Verghese ◽  
Hemant Jain ◽  
...  
Keyword(s):  
Single Dose ◽  
Conjugate Vaccine ◽  
Safety Profile ◽  
Polysaccharide Vaccine ◽  
Acceptable Safety Profile

An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12–23-month-old children

Vaccine ◽  
2011 ◽  
Vol 29 (25) ◽  
pp. 4264-4273 ◽  
Author(s):  
Markus Knuf ◽  
Anna Pantazi-Chatzikonstantinou ◽  
Ulrich Pfletschinger ◽  
Irmingard Tichmann-Schumann ◽  
Hartwig Maurer ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Tetanus Toxoid ◽  
Safety Profile ◽  
Acceptable Safety Profile

scholarly journals Persistence of Antibody After a Vi-Tetanus Toxoid Conjugate Vaccine and Effect of Boosting With a Plain Polysaccharide Vaccine on Vi Antibody and Antigen-Specific B Cells

2021 ◽  
Vol 2 ◽  
Author(s):  
Thomas Bentley ◽  
Elizabeth Jones ◽  
Celina Jin ◽  
Maria Moore ◽  
Jonathon Gardner ◽  
...  
Keyword(s):  
Single Dose ◽  
B Cells ◽  
Conjugate Vaccine ◽  
Tetanus Toxoid ◽  
Booster Vaccination ◽  
Polysaccharide Vaccine ◽  
Oral Challenge ◽  
Antibody Titres ◽  
Iga Antibody ◽  
Antibody Secreting Cells

BackgroundSalmonella enterica serovar Typhi is estimated to cause 9 to 13 million cases of typhoid fever annually. Typhoid conjugate vaccines represent a promising prophylactic measure to prevent disease, but there are few data assessing persistence of immunity. The effect of a Vi polysaccharide booster vaccine in individuals previously vaccinated with the Vi-tetanus toxoid typhoid conjugate vaccine has not been assessed previously.MethodsThirty five healthy adult volunteers received a single dose of the Vi conjugate vaccine (Vi-TT) and 37 received a single dose of Vi polysaccharide vaccine (Vi-PS) prior to oral challenge with live S. Typhi bacteria as part of a randomised controlled, phase 2b study. In addition to data previously published showing persistence of Vi IgG and IgA antibodies for 7 months after Vi vaccination, titres were measured at intervals until 13 months post-vaccination. Ten participants who received Vi-TT (both challenged and unchallenged) were re-vaccinated with Vi-PS at an interval of 19-23 months post-prime. Anti-Vi IgG and IgA titres, and Vi-specific antibody secreting cells and memory B cells were measured at seven days and one month post-boost.FindingsVi IgG and IgA antibody titres remained significantly elevated above baseline levels 13 months after priming with Vi-TT, with a 4-fold rise retained in 90% and 88% of recipients (Vi IgG and IgA, respectively). Anti-Vi IgG and IgA antibody titres were found to persist at higher levels in participants who received a single dose of Vi-TT than in those who received Vi-PS. No significant boost in Vi-antibody titre was observed in response to oral challenge with S. Typhi bacteria, one month after vaccination. Following a Vi-PS booster vaccination in those previously vaccinated with Vi-TT, anti-Vi IgG and IgA titres were significantly elevated, with similar titres observed at one month post-boost compared with one month after primary vaccination. The frequency of Vi-specific IgA antibody secreting cells increased significantly 7 days post-boost compared with pre-boost. No memory B cell response was observed following Vi-PS booster vaccination.InterpretationStrong persistence of anti-Vi IgG and IgA following Vi-TT vaccination suggests that the conjugate vaccine may offer durable protection, supporting its use in endemic settings.

An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults

Vaccine ◽  
2021 ◽  
Vol 39 (19) ◽  
pp. 2620-2627
Author(s):  
Seuk Keun Choi ◽  
Yeong Ok Baik ◽  
Chan Wha Kim ◽  
Soo Kyung Kim ◽  
Il Nam Oh ◽  
...  
Keyword(s):  
Single Dose ◽  
Conjugate Vaccine ◽  
Open Label ◽  
Clinical Phase

scholarly journals The role of idecabtagene vicleucel in patients with heavily pretreated refractory multiple myeloma

2021 ◽  
Vol 12 ◽  
pp. 204062072110196
Author(s):  
Albert Oriol ◽  
Laura Abril ◽  
Anna Torrent ◽  
Gladys Ibarra ◽  
Josep-Maria Ribera
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Safety Profile ◽  
Proteasome Inhibitors ◽  
Clinical Development ◽  
Phase Iii ◽  
Acceptable Safety Profile ◽  
Refractory Multiple Myeloma ◽  
High Risk Patients ◽  
Risk Patients

The development of several treatment options over the last 2 decades has led to a notable improvement in the survival of patients with multiple myeloma. Despite these advances, the disease remains incurable for most patients. Moreover, standard combinations of alkylating agents, immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies targeting CD38 and corticoids are exhausted relatively fast in a proportion of high-risk patients. Such high-risk patients account for over 20% of cases and currently represent a major unmet medical need. The challenge of drug resistance requires the development of highly active new agents with a radically different mechanism of action. Several immunotherapeutic modalities, including antibody–drug conjugates and T-cell engagers, appear to be promising choices for patients who develop resistance to standard combinations. Chimeric antigen-receptor-modified T cells (CAR-Ts) targeting B-cell maturation antigen have demonstrated encouraging efficacy and an acceptable safety profile compared with alternative options. Multiple CAR-Ts are in early stages of clinical development, but the first phase III trials with CAR-Ts are ongoing for two of them. After the recent publication of the results of a phase II trial confirming a notable efficacy and acceptable safety profile, idecabtagene vicleucel is the first CAR-T to gain regulatory US Food and Drug Administration approval to treat refractory multiple myeloma patients who have already been exposed to antibodies against CD38, proteasome inhibitors, and immunomodulatory agents and who are refractory to the last therapy. Here, we will discuss the preclinical and clinical development of idecabtagene vicleucel and its future role in the changing treatment landscape of relapsed and refractory multiple myeloma.

scholarly journals Pneumococcal Nasopharyngeal Carriage following Reduced Doses of a 7-Valent Pneumococcal Conjugate Vaccine and a 23-Valent Pneumococcal Polysaccharide Vaccine Booster

2010 ◽  
Vol 17 (12) ◽  
pp. 1970-1976 ◽  
Author(s):  
F. M. Russell ◽  
J. R. Carapetis ◽  
C. Satzke ◽  
L. Tikoduadua ◽  
L. Waqatakirewa ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Polysaccharide Vaccine ◽  
Dose Effect ◽  
Pneumococcal Polysaccharide Vaccine ◽  
Pneumococcal Carriage ◽  
Primary Series ◽  
Vaccine Type ◽  
Vaccine Booster ◽  
Antibody Levels

ABSTRACT This study was conducted to evaluate the effect of a reduced-dose 7-valent pneumococcal conjugate vaccine (PCV) primary series followed by a 23-valent pneumococcal polysaccharide vaccine (23vPPS) booster on nasopharyngeal (NP) pneumococcal carriage. For this purpose, Fijian infants aged 6 weeks were randomized to receive 0, 1, 2, or 3 PCV doses. Within each group, half received 23vPPS at 12 months. NP swabs were taken at 6, 9, 12, and 17 months and were cultured for Streptococcus pneumoniae. Isolates were serotyped by multiplex PCR and a reverse line blot assay. There were no significant differences in PCV vaccine type (VT) carriage between the 3- and 2-dose groups at 12 months. NP VT carriage was significantly higher (P, <0.01) in the unvaccinated group than in the 3-dose group at the age of 9 months. There appeared to be a PCV dose effect in the cumulative proportion of infants carrying the VT, with less VT carriage occurring with more doses of PCV. Non-PCV serotype (NVT) carriage rates were similar for all PCV groups. When groups were pooled by receipt or nonreceipt of 23vPPS at 12 months, there were no differences in pneumococcal, VT, or NVT carriage rates between the 2 groups at the age of 17 months. In conclusion, there appeared to be a PCV dose effect on VT carriage, with less VT carriage occurring with more doses of PCV. By the age of 17 months, NVT carriage rates were similar for all groups. 23vPPS had no impact on carriage, despite the substantial boosts in antibody levels.

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