PMID- 31029515
OWN - NLM
STAT- MEDLINE
DCOM- 20200925
LR  - 20200925
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 37
IP  - 23
DP  - 2019 May 21
TI  - Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella 
      catarrhalis vaccine.
PG  - 3113-3122
LID - S0264-410X(19)30505-5 [pii]
LID - 10.1016/j.vaccine.2019.04.041 [doi]
AB  - Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) are 
      frequent pathogens in acute exacerbations of COPD. We assessed the safety, 
      reactogenicity and immunogenicity of different investigational vaccine 
      formulations containing surface proteins of NTHi (PD and PE-PilA) and Mcat 
      (UspA2) in adults with smoking history >/=10 pack-years, to immunologically 
      represent the COPD population. Participants received two doses 60 days apart in a 
      randomised, observer-blind, placebo-controlled study (NCT02547974). In step 1, 30 
      healthy adults aged 18-40 years were randomised (1:1) to receive a non-adjuvanted 
      formulation (10-10-PLAIN) or placebo. In step 2, 90 smokers/ex-smokers aged 
      50-70 years randomly (1:1:1) received an AS01-adjuvanted formulation containing 
      either 10 microg of each antigen (10-10-AS01) or 10 microg of each NTHi antigen and 
      3.3 microg of Mcat antigen (10-3-AS01), or placebo. Incidences of solicited local 
      adverse events (AEs) tended to be highest in the AS01-adjuvanted vaccine groups. 
      Most solicited AEs had mild/moderate intensity. No vaccine-related serious AEs 
      were reported. The 10-3-AS01 formulation induced the best humoral immune response 
      against the NTHi antigens. Responses against the Mcat antigen were similar across 
      groups, with waning immunogenicity after 30 days post-dose 2. The investigational 
      NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good 
      immunogenicity in older adults with a smoking history.
CI  - Copyright (c) 2019 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All 
      rights reserved.
FAU - Van Damme, Pierre
AU  - Van Damme P
AD  - Centre for the Evaluation of Vaccination, University of Antwerp, Antwerp, 
      Belgium.
FAU - Leroux-Roels, Geert
AU  - Leroux-Roels G
AD  - Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, 
      Belgium.
FAU - Vandermeulen, Corinne
AU  - Vandermeulen C
AD  - Leuven University Vaccinology Centre, Department of Pharmaceutical and 
      Pharmacological Sciences, KU Leuven, Belgium.
FAU - De Ryck, Iris
AU  - De Ryck I
AD  - GSK Vaccines, Siena, Italy.
FAU - Tasciotti, Annaelisa
AU  - Tasciotti A
AD  - GSK Vaccines, Siena, Italy.
FAU - Dozot, Marie
AU  - Dozot M
AD  - GSK, Rixensart, Belgium.
FAU - Moraschini, Luca
AU  - Moraschini L
AD  - GSK Vaccines, Siena, Italy.
FAU - Testa, Marco
AU  - Testa M
AD  - GSK Vaccines, Siena, Italy. Electronic address: marco.x.testa@gsk.com.
FAU - Arora, Ashwani Kumar
AU  - Arora AK
AD  - GSK Vaccines, Siena, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT02547974
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190424
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Bacterial Outer Membrane Proteins)
RN  - 0 (Bacterial Vaccines)
RN  - 0 (UspA protein, Moraxella catarrhalis)
SB  - IM
MH  - Adjuvants, Immunologic/administration & dosage
MH  - Adult
MH  - Aged
MH  - Antibodies, Bacterial/*blood
MH  - Bacterial Outer Membrane Proteins/immunology
MH  - Bacterial Vaccines/administration & dosage/adverse effects/*immunology
MH  - Double-Blind Method
MH  - Female
MH  - Haemophilus influenzae
MH  - Humans
MH  - Immunity, Humoral
MH  - *Immunization Schedule
MH  - *Immunogenicity, Vaccine
MH  - Male
MH  - Middle Aged
MH  - Moraxella catarrhalis
MH  - Pulmonary Disease, Chronic Obstructive/microbiology/*prevention & control
MH  - Smokers
MH  - Young Adult
OTO - NOTNLM
OT  - Acute exacerbation
OT  - COPD
OT  - Clinical trial
OT  - Haemophilus influenzae
OT  - Moraxella catarrhalis
EDAT- 2019/04/29 06:00
MHDA- 2020/09/26 06:00
CRDT- 2019/04/29 06:00
PHST- 2018/09/13 00:00 [received]
PHST- 2019/03/26 00:00 [revised]
PHST- 2019/04/14 00:00 [accepted]
PHST- 2019/04/29 06:00 [pubmed]
PHST- 2020/09/26 06:00 [medline]
PHST- 2019/04/29 06:00 [entrez]
AID - S0264-410X(19)30505-5 [pii]
AID - 10.1016/j.vaccine.2019.04.041 [doi]
PST - ppublish
SO  - Vaccine. 2019 May 21;37(23):3113-3122. doi: 10.1016/j.vaccine.2019.04.041. Epub 
      2019 Apr 24.