- |||||||||| Capvaxive (V116) / Merck (MSD)
Trial completion, Pneumococcal vaccines: Safety and Immunogenicity of V116 in Vaccine-na (clinicaltrials.gov) - May 31, 2023
P3, N=450, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Trial completion, Pneumococcal vaccines: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6) (clinicaltrials.gov) - May 23, 2023
P3, N=717, Completed,
In conclusion, we strongly recommend sequential vaccination over single immunization in kidney transplant recipients. Active, not recruiting --> Completed
- |||||||||| Tecvayli (teclistamab) / Genmab, J&J
TECLISTAMAB REDUCES POLYCLONAL IMMUNOGLOBULIN LEVELS AND IMPAIRS VACCINATION RESPONSES IN HEAVILY PRETREATED MM PATIENTS (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1947;
Therefore, most guidelines recommend vaccination with Prevenar13 Vaccination response rates following S. pneumoniae (conjugated PCV-13 [prevenar], followed by the polysaccharide PPV-23 vaccine [pneumovax] 8 weeks later ) and H. influenzae vaccination (Act-Hib) was significantly lower in TEC-treated pts (8% and 6%, resp.) versus response in newly diagnosed MM (76% and 88%), daratumumab-na
- |||||||||| Capvaxive (V116) / Merck (MSD)
Enrollment closed, Pneumococcal vaccines: Safety and Immunogenicity of V116 in Vaccine-na (clinicaltrials.gov) - Apr 26, 2023
P3, N=440, Active, not recruiting,
Vaccination response rates following S. pneumoniae (conjugated PCV-13 [prevenar], followed by the polysaccharide PPV-23 vaccine [pneumovax] 8 weeks later ) and H. influenzae vaccination (Act-Hib) was significantly lower in TEC-treated pts (8% and 6%, resp.) versus response in newly diagnosed MM (76% and 88%), daratumumab-na Recruiting --> Active, not recruiting
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), PREVNAR 13 (pneumococcal 13-valent conjugate vaccine) / Pfizer
Trial completion, Trial completion date, Pneumococcal vaccines: Immune Response After Pneumococcal Vaccination in Patient With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Mar 30, 2023
P4, N=77, Completed,
There are two available vaccines for pneumococcus: T-cell-independent capsular polysaccharide Pneumovax and T-cell-dependent conjugated Prevnar...This is the first study to uncover older adults Active, not recruiting --> Completed | Trial completion date: Jun 2022 --> Oct 2022
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
P3 data, Journal: A phase 3 study of safety and immunogenicity of V114, a 15-valent PCV, followed by PPSV23, in children living with HIV. (Pubmed Central) - Mar 21, 2023
P3
It is currently recommended that unimmunised CD patients receive PPV-23 (Pneumovax) then lifelong 5-yearly boosters2 despite In children living with HIV, a sequential administration of V114 followed 8?weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
P3 data, Journal: Phase 3 trial to evaluate the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine 6 months later, in at-risk adults 18-49 years of age (PNEU-DAY): A subgroup analysis by baseline risk factors. (Pubmed Central) - Mar 16, 2023
V114 administered either alone or sequentially with PPSV23 6?months later was immunogenic for all 15 serotypes, including those not contained in PCV13, regardless of the number of baseline risk factors. V114 has the potential to broaden serotype coverage for at-risk adults.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Journal: T-independent responses to polysaccharides in humans mobilize marginal zone B cells prediversified against gut bacterial antigens. (Pubmed Central) - Jan 28, 2023
To identify the B cell subset(s) involved in such responses in humans, we vaccinated healthy individuals with Pneumovax, a model TI vaccine...These clones could be mainly traced back to MZ B cells, together with clonally related IgA and, to a lesser extent, IgGCD27 B cells. Recombinant monoclonal antibodies isolated from large PC clones recognized a wide array of bacterial species from the gut flora, indicating that TI responses in humans largely mobilize MZ and switched B cells that most likely prediversified during mucosal immune responses against bacterial antigens and acquired pneumococcal cross-reactivity through somatic hypermutation.
- |||||||||| Capvaxive (V116) / Merck (MSD)
Enrollment open, Pneumococcal vaccines: Safety and Immunogenicity of V116 in Vaccine-na (clinicaltrials.gov) - Jan 5, 2023
P3, N=440, Recruiting,
Recombinant monoclonal antibodies isolated from large PC clones recognized a wide array of bacterial species from the gut flora, indicating that TI responses in humans largely mobilize MZ and switched B cells that most likely prediversified during mucosal immune responses against bacterial antigens and acquired pneumococcal cross-reactivity through somatic hypermutation. Not yet recruiting --> Recruiting
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), PREVNAR 13 (pneumococcal 13-valent conjugate vaccine) / Pfizer
Enrollment open, Trial completion date, Trial primary completion date: Pneumo 2: PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2) (clinicaltrials.gov) - Jan 5, 2023
P4, N=516, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Review, Journal: Caveolae-Mediated Extracellular Vesicle (CMEV) Signaling of Polyvalent Polysaccharide Vaccination: A Host-Pathogen Interface Hypothesis. (Pubmed Central) - Dec 24, 2022
We published a study showing that improvement in response to splenectomy associated defective, in regards to the antibody response to Pneumovax 23 (23-valent polysaccharides, PPSV23), can be achieved by splenocyte reinfusion...We further delineate and explain the data sets to suggest that the dual targets on both Cav-1 and SARS-CoV-2 spike proteins may block the viral entrance and neutralize viral load, which minimizes the immune reaction against viral attacks and inflammatory responses. Thus, while presenting our immunological opinion, we answer queries and responses made by readers to our original statements published in our previous work and propose a hypothesis for all vaccination strategies, i.e., caveolae-mediated extracellular vesicle-mediated vaccine memory.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Enrollment change: Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911) (clinicaltrials.gov) - Dec 22, 2022
P3, N=850, Active, not recruiting,
Thus, while presenting our immunological opinion, we answer queries and responses made by readers to our original statements published in our previous work and propose a hypothesis for all vaccination strategies, i.e., caveolae-mediated extracellular vesicle-mediated vaccine memory. N=1300 --> 850
- |||||||||| Capvaxive (V116) / Merck (MSD)
Enrollment closed: A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4) (clinicaltrials.gov) - Dec 8, 2022
P3, N=2040, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Predictors of Hospitalizations and Death from COVID-19 in Patients with Multiple Myeloma () - Nov 29, 2022 - Abstract #ASH2022ASH_7689;
Race, ethnicity, gender and BMI, smoking status and flu/pneumovax vaccination did not have any effect on the odds of neither hospitalization nor death...More data is required to understand the effect of COVID-19 in vaccinated patients with multiple myeloma and other hematologic malignancies. Some limitations of this dual center institution study are the small sample size.
- |||||||||| Capvaxive (V116) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Enrollment closed, Pneumococcal vaccines: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6) (clinicaltrials.gov) - Nov 25, 2022
P3, N=700, Active, not recruiting,
Some limitations of this dual center institution study are the small sample size. Recruiting --> Active, not recruiting
- |||||||||| Prevnar 20 (pneumococcal 20-valent conjugate vaccine) / Pfizer
Journal: Apexxnar®, 20-valent pneumococcal conjugate vaccine (Pubmed Central) - Nov 16, 2022
Although polysaccharide vaccines (PPV23, Pneumovax 23®) have already provided protection in at-risk individuals, they have been imperfect, mainly because the development of anti-polysaccharide antibodies occurs without the help of T cells...The first available vaccine of this type for adults was Prevenar 13®, targeting 13 polysaccharides of S. pneumoniae (PCV13)...The Belgian Superior Health Council has recently reiterated the importance of vaccinating at-risk individuals against S. pneumoniae (a vaccination that is still under-performed). It now recommends vaccination with PCV20 (Apexxnar®) as the preferred primary vaccination regimen in high-risk adults with co-morbidities or in good health aged between 65 and 85 years.
- |||||||||| Capvaxive (V116) / Merck (MSD)
Enrollment open, Pneumococcal vaccines: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-na (clinicaltrials.gov) - Nov 16, 2022
P3, N=1400, Recruiting,
It now recommends vaccination with PCV20 (Apexxnar®) as the preferred primary vaccination regimen in high-risk adults with co-morbidities or in good health aged between 65 and 85 years. Not yet recruiting --> Recruiting
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Journal: The IgM response to pneumococcal polysaccharide vaccine is sufficient for conferring immunity. (Pubmed Central) - Nov 15, 2022
We found that immunization of wildtype and activation-induced cytidine deaminase-deficient mice capable of producing only IgM with Pneumovax®23 generated comparable anti-PPS IgM and resistance to lethal systemic challenge with S. pneumoniae. These data suggests that an IgM response to PPS vaccines is sufficient for conferring immunity.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Prevnar 20 (pneumococcal 20-valent conjugate vaccine) / Pfizer
Trial initiation date: Anti-pneumococcal Vaccine Strategy in Patients with Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Nov 14, 2022
P2, N=70, Not yet recruiting,
These data suggests that an IgM response to PPS vaccines is sufficient for conferring immunity. Initiation date: Aug 2022 --> Dec 2022
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), PREVNAR 13 (pneumococcal 13-valent conjugate vaccine) / Pfizer
Enrollment closed, Trial completion date, Pneumococcal vaccines: Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels (clinicaltrials.gov) - Nov 10, 2022
P4, N=132, Active, not recruiting,
Trial completion date: Oct 2022 --> May 2023 | Trial primary completion date: Oct 2022 --> Jan 2023 Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Nov 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Immunogenicity of the Currently Recommended Pneumococcal Vaccination Schedule in Patients with Chronic Lymphocytic Leukaemia (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4495;
The vaccination schedule recommended in the European Conference on Infections in Leukaemia (ECIL) 7 guideline consists of Prevnar13®, a 13-valent pneumococcal conjugated vaccine (PCV13) followed 2 months later by Pneumovax23®, a 23-valent polysaccharide vaccine (PPSV23)...Of the 113 patients 33 had previously received CLL treatment, including rituximab (22 patients), cytotoxic chemotherapy (11), ibrutinib (10) and/or venetoclax (7)...These findings emphasize the importance of further investigation into the pneumococcal vaccination response in CLL patients. Since patients with CLL are insufficiently protected after a single dose of PCV13, research should focus on multi-dose PCV schedules with the currently available higher valent T cell dependent conjugate vaccines.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Causes of Death in Patients with Sickle Cell Disease from a Large Population-Based Cohort (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3307;
Patients beginning transition to adult care are at risk of becoming lost to follow-up and may experience difficulties transitioning to adult care. Future analyses will include review of regional hospital where available, and CDC’s National Death Index.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date: Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911) (clinicaltrials.gov) - Nov 4, 2022
P3, N=1300, Active, not recruiting,
Future analyses will include review of regional hospital where available, and CDC’s National Death Index. Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Feb 2023 | Trial primary completion date: Jul 2023 --> Feb 2023
- |||||||||| Trial completion date: Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - Oct 31, 2022
P4, N=500, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Feb 2023 | Trial primary completion date: Jul 2023 --> Feb 2023 Trial completion date: Aug 2023 --> Aug 2024
- |||||||||| Journal: Adult immunization. (Pubmed Central) - Oct 14, 2022
Here, we highlight how some methodological limitations may have affected results and conclusions of a published study described by Chandler et al. No abstract available
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD)
Recurrent Lung Infections In A Heterozygous Carrier Of Novel NSMCE3 Mutation. (Exhibit Hall (Upper Concourse); Monitor 06) - Oct 10, 2022 - Abstract #ACAAI2022ACAAI_934;
He also had marginally-low IgM, but showed intact humoral response to HiB vaccine and Pneumovax...Our patient has a missense mutation in one NSMCE3 allele, which may affect the protein product's conformation. Since this protein functions in DNA repair and known mutations have been associated with pneumonia and viral infections, we hypothesize that his reduced level of normal protein may underlie his recurrent pneumonias.
- |||||||||| Pneumovax 23 (23-valent pneumococcal polysaccharide) / Merck (MSD), Kineret (anakinra) / SOBI
X-linked Inhibitor Of Apoptosis Deficiency In A Patient With Adult-Onset Recurrent Febrile Illnesses (Exhibit Hall (Upper Concourse); Monitor 06) - Oct 10, 2022 - Abstract #ACAAI2022ACAAI_930;
At age 41 he demonstrated persistent hypogammaglobulinemia (IgG 610-635, reference range 767-1590 mg/dl; IgM 28-33, reference range 37-286 mg/dl), elevated antinuclear antibodies, and poor Pneumovax response (adequate response to serotypes 9V, 2, 6B)...The patient was started on IVIG and Anakinra with good response to treatment...The clinical phenotype and presentation of XIAP deficiency is variable and can often mimic more common diseases such as CVID. Even in patients without a history of IBD or HLH, genetic testing to detect XIAP deficiency should still be considered given its variable presentation.
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