PMID- 30906291
OWN - NLM
STAT- MEDLINE
DCOM- 20200917
LR  - 20200917
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 10
DP  - 2019
TI  - Booster Vaccination With GVGH Shigella sonnei 1790GAHB GMMA Vaccine Compared to 
      Single Vaccination in Unvaccinated Healthy European Adults: Results From a Phase 
      1 Clinical Trial.
PG  - 335
LID - 10.3389/fimmu.2019.00335 [doi]
LID - 335
AB  - The investigational Shigella sonnei vaccine (1790GAHB) based on GMMA (generalized 
      modules for membrane antigens) is immunogenic, with an acceptable safety profile 
      in adults. However, pre-vaccination anti-S. sonnei lipopolysaccharide (LPS) 
      antibody levels seemed to impact vaccine-related immune responses. This phase 1, 
      open-label, non-randomized extension study (ClinicalTrials.gov: NCT03089879) 
      evaluated immunogenicity of a 1790GAHB booster dose in seven adults with 
      undetectable antibodies prior to priming with three 1790GAHB vaccinations 2-3 
      years earlier (boosted group), compared to one dose in 28 vaccine-naive 
      individuals (vaccine-naive group). Anti-S. sonnei LPS serum IgG geometric mean 
      concentrations and seroresponse (increase of >/=25 EU or >/=50% from baseline 
      antibody </= 50 EU and >/=50 EU, respectively) rates were calculated at vaccination 
      (day [D]1), D8, D15, D29, D85. Safety was assessed. Geometric mean concentrations 
      at D8 were 168 EU (boosted group) and 32 EU (vaccine-naive group). Response 
      peaked at D15 (883 EU) and D29 (100 EU) for the boosted and vaccine-naive groups. 
      Seroresponse rates at D8 were 86% (boosted group) and 24% (vaccine-naive group) 
      and increased at subsequent time points. Across both groups, pain (local) and 
      fatigue (systemic) were the most frequent solicited adverse events (AEs). 
      Unsolicited AEs were reported by 57% of boosted and 25% of vaccine-naive 
      participants. No deaths, serious AEs, or AEs of special interest (except one mild 
      neutropenia case, possibly vaccination-related) were reported. One 1790GAHB dose 
      induced a significant booster response in previously-primed adults, regardless of 
      priming dose, and strong immune response in vaccine-naive individuals. 
      Vaccination was well tolerated.
FAU - Launay, Odile
AU  - Launay O
AD  - Universite Paris Descartes, Sorbonne Paris Cite, Paris, France.
AD  - Inserm CIC 1417, F-CRIN I-REIVAC, Paris, France.
AD  - Assistance Publique Hopitaux de Paris, CIC Cochin-Pasteur, Paris, France.
FAU - Ndiaye, Augustin G W
AU  - Ndiaye AGW
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Conti, Valentino
AU  - Conti V
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Loulergue, Pierre
AU  - Loulergue P
AD  - Universite Paris Descartes, Sorbonne Paris Cite, Paris, France.
AD  - Inserm CIC 1417, F-CRIN I-REIVAC, Paris, France.
AD  - Assistance Publique Hopitaux de Paris, CIC Cochin-Pasteur, Paris, France.
FAU - Scire, Antonella Silvia
AU  - Scire AS
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Landre, Anais Maugard
AU  - Landre AM
AD  - Universite Paris Descartes, Sorbonne Paris Cite, Paris, France.
AD  - Inserm CIC 1417, F-CRIN I-REIVAC, Paris, France.
AD  - Assistance Publique Hopitaux de Paris, CIC Cochin-Pasteur, Paris, France.
FAU - Ferruzzi, Pietro
AU  - Ferruzzi P
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Nedjaai, Naouel
AU  - Nedjaai N
AD  - Universite Paris Descartes, Sorbonne Paris Cite, Paris, France.
AD  - Inserm CIC 1417, F-CRIN I-REIVAC, Paris, France.
AD  - Assistance Publique Hopitaux de Paris, CIC Cochin-Pasteur, Paris, France.
FAU - Schutte, Lena Dorothee
AU  - Schutte LD
AD  - GSK, Marburg, Germany.
FAU - Auerbach, Joachim
AU  - Auerbach J
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Marchetti, Elisa
AU  - Marchetti E
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Saul, Allan
AU  - Saul A
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Martin, Laura B
AU  - Martin LB
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
FAU - Podda, Audino
AU  - Podda A
AD  - GSK Vaccines Institute for Global Health, Siena, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT03089879
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20190308
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Lipopolysaccharides)
RN  - 0 (Shigella Vaccines)
SB  - IM
MH  - Adult
MH  - Antibodies, Bacterial/blood
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - *Immunization, Secondary/adverse effects
MH  - Immunoglobulin G/blood
MH  - Immunologic Memory
MH  - Lipopolysaccharides/immunology
MH  - Male
MH  - Middle Aged
MH  - *Shigella Vaccines/adverse effects
MH  - Shigella sonnei/*immunology
MH  - Vaccination/adverse effects/*methods
PMC - PMC6418009
OTO - NOTNLM
OT  - 1790GAHB
OT  - GMMA (generalized modules for membrane antigen)
OT  - Shigella sonnei
OT  - antibody persistence
OT  - booster response
OT  - safety
EDAT- 2019/03/25 06:00
MHDA- 2020/09/18 06:00
PMCR- 2019/01/01
CRDT- 2019/03/26 06:00
PHST- 2019/01/04 00:00 [received]
PHST- 2019/02/08 00:00 [accepted]
PHST- 2019/03/26 06:00 [entrez]
PHST- 2019/03/25 06:00 [pubmed]
PHST- 2020/09/18 06:00 [medline]
PHST- 2019/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2019.00335 [doi]
PST - epublish
SO  - Front Immunol. 2019 Mar 8;10:335. doi: 10.3389/fimmu.2019.00335. eCollection 
      2019.