Tolerability and immunogenicity of an eleven-valent pneumococcal conjugate vaccine in healthy toddlers

Wuorimaa, Tomi; Dagan, Ron; Eskola, Juhani; Janco, Jacob; Åhman, Heidi; Leroy, Odile; Käyhty, Helena

doi:10.1097/00006454-200103000-00011

Cited by 53 publications

(31 citation statements)

References 31 publications

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“…Priming mice with carrier protein before administration of a conjugate vaccine can either augment or suppress immune response (17); perhaps the latter effect explains the lack of adjuvant effect of alum in our study population. A recent study with children of an 11-valence pneumococcal conjugate vaccine with both diphtheria and TT as carrier proteins also found that alum had no significant effect on immunogenicity (21). Despite the effectiveness of aluminum-based adjuvants in improving immune response to toxoids (6) and the mechanism described to explain its potent effect in vivo (20), little information exists regarding the effect of alum adjuvant on the immunogenicity of conjugate vaccines.…”

Section: Discussionmentioning

confidence: 99%

Effects of Alum Adjuvant or a Booster Dose on Immunogenicity during Clinical Trials of Group B Streptococcal Type III Conjugate Vaccines

et al. 2001

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Phase 1 and 2 clinical trials of group B streptococcal (GBS) capsular polysaccharide (CPS)-protein conjugate vaccines in healthy adults have demonstrated their safety and improved immunogenicity compared with uncoupled CPSs. Two recent trials sought to determine (i) whether adsorption of conjugate vaccine to aluminum hydroxide would improve immunogenicity and (ii) whether the CPS-specific immunoglobulin G (IgG) response could be boosted by administration of a second dose. Adsorption of GBS type III CPS-tetanus toxoid (III-TT) conjugate vaccine to alum did not improve the immune response to a 12.5-g dose in healthy adult recipients. Four weeks after vaccination, the geometric mean antibody concentrations (GMCs) for the 15 recipients of III-TT with or without alum were 3.3 and 3.6 g/ml, respectively. In the second trial, 36 healthy adults vaccinated previously with GBS III-TT conjugate were given a second 12.5-g dose 21 months later. At 4 weeks after the second dose, the GMCs of type III CPS-specific IgG were similar to those measured 4 weeks after the primary vaccination, suggesting a lack of a booster response. However, 8 (22%) of the 36 participants who had undetectable III CPS-specific IgG (<0.05 g/ml) before the first dose of III-TT conjugate exhibited a booster response to the second dose, with a fourfold-greater GMC of type III CPS-specific IgG than after the initial immunization. These results suggest that prior natural exposure to type III GBS or a related antigen may be responsible for the brisk IgG response to CPS noted in most adults after vaccination. However, a second dose of GBS III-TT conjugate vaccine may be required for adults whose initial CPS-specific IgG concentrations are very low and would also restore the initial peak-specific III CPS-IgG in responders to previous vaccination.

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Section: Discussionmentioning

confidence: 99%

Effects of Alum Adjuvant or a Booster Dose on Immunogenicity during Clinical Trials of Group B Streptococcal Type III Conjugate Vaccines

et al. 2001

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“…In another study by Nieminen et al (13), antibody responses to four 4-valent PCVs were analyzed by non-22F inhibition EIA, and a Ͼ2-fold increase in both anti-PPS IgG and IgM concentrations was detected in at least 25 of 40 children aged 24 months. Also, comparison of the anti-PPS14 IgM concentrations in pre-and postimmunization sera (unpublished data) from a previous study of 11-valent PCV conducted among Israeli toddlers (28) showed low prevaccination anti-PPS14 IgM concentrations and a Ͼ2-fold increase in postvaccination anti-PPS14 IgM concentrations in 15 of 23 toddlers, suggesting vaccine-induced IgM responses (unpublished data).…”

Section: Discussionmentioning

confidence: 90%

Serum IgM Antibodies Contribute to High Levels of Opsonophagocytic Activities in Toddlers Immunized with a Single Dose of the 9-Valent Pneumococcal Conjugate Vaccine

Simell

Nurkka

Ekström

et al. 2012

Clin. Vaccine Immunol.

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“…The remaining four polysaccharides that needed to be administered at higher doses to stimulate immunogenicity were conjugated to DT. The administration of this mixedcarrier conjugate (PncD/T11) simultaneously with a variety of concomitant antigens, including TT and PRP-T to adults, toddlers, and infants, in the presence of wP resulted in a safe and immunogenic formulation (18,21,27,28) (Dagan et al, 37th Annu. IDSA Meet., abstr.…”

Section: Discussionmentioning

confidence: 99%

“…This 11-valent vaccine (PncD/T11) contained seven polysaccharides conjugated to TT and four polysaccharides (those judged to need the largest carrier amounts) conjugated to DT. Initial studies showed it was safe and immunogenic for all 11 pneumococcal serotypes included in the vaccine (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) when administered alone or simultaneously with other childhood vaccines, including a combined vaccine consisting of DTwP, PRP-T, and inactivated trivalent poliovirus vaccine (DTwP/IPV/PRP-T) (18,21,27,28;Dagan et al,37th Annu. Infect.…”

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confidence: 99%

Reduction of Antibody Response to an 11-Valent Pneumococcal Vaccine Coadministered with a Vaccine Containing Acellular Pertussis Components

Dagan

Green

Maleckar³

et al. 2004

Infect Immun

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In pneumococcal conjugate vaccines (PCVs), polysaccharide antigens are often conjugated to protein carriers related to other common vaccines. It is therefore important to test PCV interaction with other pediatric vaccines when administered simultaneously. We assessed the immune response to an 11-valent PCV conjugated to diphtheria and tetanus carriers (PncD/T11), administered concomitantly, but in separate sites, with a combined vaccine containing epitopes related antigenically to the carriers: polyribosylribitol phosphate-tetanus toxoid (PRP-T), diphtheria toxoid (DT), and tetanus toxoid (TT). In addition, these combinations contained inactivated poliovirus vaccine (IPV) and either whole-cell pertussis (wP) or acellular pertussis (aP) components. After coadministration of PncD/T11 with the combined vaccine containing wP (DTwP/IPV/PRP-T), the responses to all polysaccharides in the PncD/T11 were satisfactory. In contrast, when coadministered with an aP-containing combination (DTaP/IPV/PRP-T), the response to all seven pneumococcal conjugates to TT was significantly reduced after primary and booster immunization. The pneumococcal conjugates to DT were not significantly reduced after the primary series, but were somewhat reduced after booster. It is likely that some suppression of the tetanus-mediated response occurred even when the PncD/T11 was coadministered with wP, but this suppression was masked by the adjuvant effect of wP. By replacing wP with aP, this adjuvant effect was removed, unmasking the suppression of the tetanus-mediated response. With the increasing use of multiple aP-containing vaccines in infancy, novel approaches to adjuvants and carrier protein technology are likely to be required.

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Tolerability and immunogenicity of an eleven-valent pneumococcal conjugate vaccine in healthy toddlers

Abstract: An 11-valent mixed carrier pneumococcal conjugate vaccine is safe and immunogenic in toddlers. The use of an adjuvant do not seem to offer any significant benefit.

Cited by 53 publications

References 31 publications

Effects of Alum Adjuvant or a Booster Dose on Immunogenicity during Clinical Trials of Group B Streptococcal Type III Conjugate Vaccines

Effects of Alum Adjuvant or a Booster Dose on Immunogenicity during Clinical Trials of Group B Streptococcal Type III Conjugate Vaccines

Serum IgM Antibodies Contribute to High Levels of Opsonophagocytic Activities in Toddlers Immunized with a Single Dose of the 9-Valent Pneumococcal Conjugate Vaccine

Reduction of Antibody Response to an 11-Valent Pneumococcal Vaccine Coadministered with a Vaccine Containing Acellular Pertussis Components

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