Delving into the Latest Updates on Pneumococcal polysaccharide vaccine 23-valent (Walvax Biotechnology) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Multivalent vaccine

Synonyms

23-valent pneumococcal polysaccharide vaccine, 23-valent pneumococcal vaccine, Pneumococcal 23-valent polysaccharide vaccine

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Pneumococcal Infections

Inactive Indication-

Originator Organization

Yuxi Walvax Biotechnology Co., Ltd.

Active Organization

Yuxi Walvax Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (22 Mar 2017),

Pneumococcal Infections

Regulation-

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BACKGROUNDPneumococcal vaccines are effective in preventing pneumococcal diseases in adults. The evaluation of the antibodies persistence to the 23-valent pneumococcal polysaccharide vaccine (PPV23) could provide evidence on PPV23 revaccination.RESEARCH DESIGN AND METHODSAdults aged ≥ 60 years were selected and vaccinated with PPV23 in Shanghai, and followed up for 5 years with blood samples collection of a 1-year interval. The geometric mean concentrations (GMC) of the IgG against 23 pneumococcal serotypes covered by PPV23 were detected using enzyme-linked immunosorbent assay. The antibodies to 23 pneumococcal serotypes among different groups was analyzed using statistical analysis.RESULTSOverall, 517 participants completed all six visits over a 5-year period (2013-2018). The GMC of 23 serotypes in adults aged ≥ 60 years decreased slowly after PPV23 vaccination compared to baseline pre-vaccination (P < 0.05), except serotype 3. Additionally, the multiplicative increase in the antibody concentration after PPV23 vaccination was greater, and the antibody levels of serotypes 1 and 6B were significantly higher at visit 5 than at visit 4 (P < 0.05).CONCLUSIONSThe pneumococcal antibodies in elderly after PPV23 vaccination could sustain high levels over long-term follow-up, which suggested that the interval of revaccination with PPV23 in elderly should be at least 5 years after the first vaccination.

31 Dec 2024·Expert Review of Vaccines

Adult indication 13-valent pneumococcal conjugate vaccine clinical development overview: formulation, safety, immunogenicity (dosing and sequence), coadministration, and efficacy

Review

Author: Fletcher, Mark A. ; Paradiso, Peter R. ; Daigle, Derek ; del Carmen Morales, Graciela ; Schmoele-Thoma, Beate ; Vojicic, Jelena

INTRODUCTIONThere was no 13-valent pneumococcal conjugate vaccine (PCV13) adult antibody concentration threshold regulatory criterion for licensure - unlike the pediatric indication; consequently, for the adult indication, PCV13 serotype-specific opsonophagocytic activity (OPA) geometric mean titer (GMT) values were immunobridged to the 23-valent plain polysaccharide vaccine (PPV23) to infer efficacy against invasive pneumococcal disease (IPD). Subsequently, a double-blind, randomized, controlled PCV13 efficacy trial (CAPiTA) was performed in community-living, older adults to confirm efficacy against vaccine-serotype IPD (VT-IPD) and establish efficacy against vaccine-serotype pneumococcal community-acquired pneumonia (VT-CAP).AREAS COVEREDThis article summarizes 31 publications from the PCV13 adult indication clinical development trials and other PCV13 clinical studies, organized by formulation, reactogenicity and safety, immunogenicity, coadministration, and clinical efficacy.EXPERT OPINIONPCV13 had a favorable safety profile with an OPA response generally greater than PPV23 irrespective of age and of previous pneumococcal vaccination. PCV13 primed for enhanced immune responses with subsequent PCV13 or PPV23 dosing. Conversely, PPV23 was shown to blunt the response to subsequent PCV13. CAPiTA demonstrated PCV13 efficacy for at least five years against both VT-IPD and VT-CAP. The PCV13 clinical development program provided fundamental insights into this vaccine's adult-specific immune responses and confirmed the advantages of conjugate over plain polysaccharide technology.

01 Sep 2024·Vaccine

Immunogenicity of a seasonal influenza and a pneumococcal polysaccharide vaccine in multiple sclerosis patients under disease modifying therapies: A single-center prospective study

Article

Author: Voumvourakis, Konstantinos ; Angelakis, Emmanouil ; Chondrogianni, Maria ; Mpizta, Giota ; Giannopoulos, Sotirios ; Marantos, Theodoros ; Kyriazopoulou, Evdoxia ; Kitsos, Dimitrios ; Tsiodras, Sotirios ; Papadopoulos, Antonios

BACKGROUNDImmunogenicity of influenza and pneumococcal vaccines varies and requires further elucidation in patients with multiple sclerosis (MS) under treatment with disease-modifying therapies (DMTs).METHODSAdult MS patients who consented with vaccination after standard-of-care consultation by their treating physicians were enrolled. All received a single dose of an inactivated quadrivalent influenza vaccine and of the 23-valent pneumococcal vaccine. A blood sample was collected before and after four weeks of vaccination for measurement of antibodies against Influenza A, B and S. pneumoniae. Patients were followed-up for adverse events and MS relapse for 12 months.RESULTSOne hundred and seventy-two patients (65.7 % female, mean age 42 ± 13 years old, mean MS duration 7.6 ± 7.2 years, 81.4 % under DMTs) were enrolled from November 2019 to March 2020. Antibody measurements were available for 151 patients. Seropositivity for anti-PPSV23 did not differ between baseline and at 4 weeks of follow-up (n = 56, 37.1 %). There was a significant increase of absolute antibody titers post-vaccination for both influenza A and B (p < 0.001). For Influenza A, seropositivity was evident for 57 (37.7 %) patients at 4 weeks compared to 19 (12.6 %) patients at baseline (p_McNemar < 0.001). For Influenza Β, 110 (72.8 %) seroconverted 4 weeks after vaccination compared to 12 (7.9 %) at baseline (p_McNemar < 0.001). Interferon and fumarate did not affect influenza seroconversion while rituximab was associated with lower titers. Mild local AEs (pain, edema) were observed in 23.8 %; no severe AE was reported. Thirty-four patients (19.8 %) had a relapse during the 12-month follow-up; none was attributed to the vaccination.CONCLUSIONSSeroconversion in MS patients on treatment was more frequent following influenza compared to PPSV23 vaccination. Rituximab had an effect on the height of the immune response. Better immunization coverage as well as future evaluation of the breadth of immune response elicited by immunization is necessary for these patients.

100 Deals associated with Pneumococcal polysaccharide vaccine 23-valent (Walvax Biotechnology)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Pneumococcal Infections	CN	Yuxi Walvax Biotechnology Co., Ltd.	22 Mar 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02592486 (CTgov)	Phase 4	Pneumonia, Pneumococcal \| Influenza, Human	162	PPV23+ Fluvic HA syringe (Simultaneous Administration Group)	lxsodewtal(nfthoaouaw) = zlnshgjnqw iaiaulfmzu (jewrswfvvf, rrnsdnqfpv - uvswwtqqxy) View more	-	31 Jan 2019
				PPV23+ Fluvic HA syringe (Sequential Administration Group)	lxsodewtal(nfthoaouaw) = udsqaapsxk iaiaulfmzu (jewrswfvvf, tjbcpqbudc - afwcykjars) View more
ERS2017	Not Applicable	-	130	23-valent pneumococcal polysaccharide vaccine	gghgtksxme(qaqmdhxtqx) = sjiktdjkvr bqecfkevvz (pjkvsyatlj )	Positive	01 Sep 2017
ERS2016	Not Applicable	Kidney Failure, Chronic	545	23-valent pneumococcal polysaccharide vaccine	dbtgcryzxv(niwtsjodrk): OR = 0.61 (95% CI, 0.343 - 1.085), P-Value = 0.092 View more	Negative	01 Sep 2016
				23-valent pneumococcal polysaccharide vaccine