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Safety and immunogenicity of fully liquid and lyophilized formulations of an investigational trivalent group B streptococcus vaccine in healthy non-pregnant women: Results from a randomized comparative phase II trial

J. Beran, G. Leroux-Roels, P. Van Damme, J. de Hoon, C. Vandermeulen, M. Al-Ibrahim, C. Johnson, J. Peterson, S. Baker, C. Seidl, A. Dreisbach, A. Karsten, B. Corsaro, O. Henry, M. Lattanzi, Z. Bebia

. 2020 ; 38 (16) : 3227-3234. [pub] 20200310

Language English Country Netherlands

Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc21020641
E-resources Online Full text

NLK ProQuest Central from 2002-01-01 to 2 months ago
Nursing & Allied Health Database (ProQuest) from 2002-01-01 to 2 months ago
Health & Medicine (ProQuest) from 2002-01-01 to 2 months ago
Family Health Database (ProQuest) from 2002-01-01 to 2 months ago
Health Management Database (ProQuest) from 2002-01-01 to 2 months ago
Public Health Database (ProQuest) from 2002-01-01 to 2 months ago

Links

PubMed 32169390
DOI 10.1016/j.vaccine.2020.02.085
Knihovny.cz E-resources

BACKGROUND: We evaluated the safety and immunogenicity of liquid and lyophilized formulations of an investigational trivalent group B streptococcus (GBS) vaccine in non-pregnant women and assessed the formulations' equivalence in terms of serotype-specific immune response. METHODS: This phase II, randomized, comparative, observer-blind trial enrolled healthy non-pregnant women 18-40 years of age. Women received a single dose of fully liquid (n = 529) or lyophilized (n = 521) trivalent GBS vaccine on day 1. Safety assessments were performed up to day 181 (study termination). Serotype Ia/Ib/III-specific immunoglobulin G (IgG) antibodies were measured in sera from women on day 1 (pre-vaccination) and day 31. Equivalence between the two formulations was demonstrated if the two-sided 95% confidence interval (CI) for the ratio (liquid/lyophilized) of the geometric mean concentrations (GMCs) on day 31 was contained in a (0.5, 2.0) interval for each serotype. RESULTS: Solicited and unsolicited adverse events were reported at similar rates for both formulations. Serious adverse events were reported for six (1.1%) liquid GBS and nine (1.7%) lyophilized GBS vaccinated women, none of which were considered related to vaccination or fatal. On day 31, serotype-specific IgG concentrations were 8-16-fold higher than on day 1 in both groups. Equivalence of the liquid to the lyophilized formulation 30 days post-vaccination was demonstrated as the 95% CIs of the GMC ratios were within the pre-specified interval for the three serotypes: GMC ratios were 1.02 (95% CI: 0.79, 1.32) for serotype Ia, 0.93 (0.71, 1.21) for serotype Ib and 0.99 (0.76, 1.30) for serotype III. CONCLUSIONS: Both formulations of the investigational trivalent GBS vaccine had favorable safety profiles and induced similar GBS serotype-specific antibody concentrations. This study demonstrated that the fully liquid formulation was equivalent to the lyophilized formulation in healthy non-pregnant women in terms of immunogenicity for all three serotypes. CLINICAL TRIALS REGISTRATION: NCT02270944.

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$a BACKGROUND: We evaluated the safety and immunogenicity of liquid and lyophilized formulations of an investigational trivalent group B streptococcus (GBS) vaccine in non-pregnant women and assessed the formulations' equivalence in terms of serotype-specific immune response. METHODS: This phase II, randomized, comparative, observer-blind trial enrolled healthy non-pregnant women 18-40 years of age. Women received a single dose of fully liquid (n = 529) or lyophilized (n = 521) trivalent GBS vaccine on day 1. Safety assessments were performed up to day 181 (study termination). Serotype Ia/Ib/III-specific immunoglobulin G (IgG) antibodies were measured in sera from women on day 1 (pre-vaccination) and day 31. Equivalence between the two formulations was demonstrated if the two-sided 95% confidence interval (CI) for the ratio (liquid/lyophilized) of the geometric mean concentrations (GMCs) on day 31 was contained in a (0.5, 2.0) interval for each serotype. RESULTS: Solicited and unsolicited adverse events were reported at similar rates for both formulations. Serious adverse events were reported for six (1.1%) liquid GBS and nine (1.7%) lyophilized GBS vaccinated women, none of which were considered related to vaccination or fatal. On day 31, serotype-specific IgG concentrations were 8-16-fold higher than on day 1 in both groups. Equivalence of the liquid to the lyophilized formulation 30 days post-vaccination was demonstrated as the 95% CIs of the GMC ratios were within the pre-specified interval for the three serotypes: GMC ratios were 1.02 (95% CI: 0.79, 1.32) for serotype Ia, 0.93 (0.71, 1.21) for serotype Ib and 0.99 (0.76, 1.30) for serotype III. CONCLUSIONS: Both formulations of the investigational trivalent GBS vaccine had favorable safety profiles and induced similar GBS serotype-specific antibody concentrations. This study demonstrated that the fully liquid formulation was equivalent to the lyophilized formulation in healthy non-pregnant women in terms of immunogenicity for all three serotypes. CLINICAL TRIALS REGISTRATION: NCT02270944.
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$a Johnson, Casey $u Johnson County Clin-Trials, Lenexa, KS, United States. Electronic address: cjohnson@jcct.com
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$a Peterson, James $u Foothill Family Clinic, Salt Lake City, UT, United States. Electronic address: jpeterson@foothillfamilyclinic.com
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$a Baker, Sherryl $u GSK, Cambridge, MA, United States. Electronic address: sb@rscstatconsulting.com
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$a Seidl, Claudia $u GSK, Siena, Italy. Electronic address: claudia.x.seidl@gsk.com
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$a Dreisbach, Annette $u GSK, Marburg, Germany. Electronic address: annette.x.dreisbach@gsk.com
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$a Karsten, Annette $u GSK, Marburg, Germany. Electronic address: annette.x.karsten@gsk.com
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$a Lattanzi, Maria $u GSK, Siena, Italy. Electronic address: maria.x.lattanzi@gsk.com
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