PMID- 31843266
OWN - NLM
STAT- MEDLINE
DCOM- 20210209
LR  - 20220323
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 2
DP  - 2020 Jan 10
TI  - Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine 
      candidate in adults, toddlers, and infants in The Gambia-Results of a phase 1/2 
      randomized, double-blinded, controlled trial.
PG  - 399-410
LID - S0264-410X(19)31148-X [pii]
LID - 10.1016/j.vaccine.2019.08.072 [doi]
AB  - BACKGROUND: A more affordable pneumococcal conjugate vaccine (PCV) that provides 
      comparable protection to current PCVs is needed to ensure sustainable access in 
      resource-limited settings. Serum Institute of India Pvt. Ltd.'s PCV candidate 
      (SIIPL-PCV) has the potential to meet this need as manufacturing efficiency has 
      been optimized and the vaccine targets the most prevalent disease-causing 
      serotypes in Africa and Asia. We report SIIPL-PCV's safety, tolerability, and 
      immunogenicity in adults, toddlers, and infants in The Gambia. METHODS: This 
      phase 1/2, randomized, double-blind trial sequentially enrolled 34 PCV-naive 
      adults (18-40 years old), 112 PCV (Prevenar 13(R) [PCV13])-primed toddlers 
      (12-15 months old), and 200 PCV-naive infants (6-8 weeks old), who were 
      randomized (1:1) to receive SIIPL-PCV or a licensed comparator vaccine. Infants 
      received three-doses of SIIPL-PCV or PCV13 at 6, 10, and 14 weeks of age 
      co-administered with routine Expanded Program on Immunization (EPI) vaccines. 
      Reactogenicity was solicited through seven-days post-vaccination; unsolicited 
      adverse events (AEs) were assessed throughout the study. The safety and 
      immunogenicity of a matching booster at 10-14 months of age were evaluated in a 
      subset of 96 infants. Immune responses were evaluated post-primary and pre- and 
      post-booster vaccinations. RESULTS: Reactogenicity was primarily mild-to-moderate 
      in severity. In infants, the most common solicited reactions were injection-site 
      tenderness and fever, with no meaningful treatment-group differences. There were 
      no serious or severe vaccine-related AEs and no meaningful trends in SAEs, 
      vaccine-related AEs, or overall AEs. Infant post-primary seroresponse rates (IgG 
      level >/= 0.35 microg/mL) were >/=89% for all serotypes except 6A (79%) in the SIIPL-PCV 
      group. IgG GMCs were >1 microg/mL for all serotypes in both SIIPL-PCV and PCV13 
      groups. Post-booster GMCs were comparable between groups. CONCLUSION: SIIPL-PCV 
      was well-tolerated, had an acceptable safety profile, and was immunogenic for all 
      vaccine serotypes. Results support the evaluation of SIIPL-PCV in a phase 3 
      non-inferiority trial. Clinicaltrials.gov: NCT02308540.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Clarke, Ed
AU  - Clarke E
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia. 
      Electronic address: Ed.Clarke@lshtm.ac.uk.
FAU - Bashorun, Adedapo O
AU  - Bashorun AO
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.
FAU - Okoye, Michael
AU  - Okoye M
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.
FAU - Umesi, Ama
AU  - Umesi A
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.
FAU - Badjie Hydara, Mariama
AU  - Badjie Hydara M
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.
FAU - Adigweme, Ikechukwu
AU  - Adigweme I
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.
FAU - Dhere, Rajeev
AU  - Dhere R
AD  - Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road Hadapsar, 
      Pune 411028, India.
FAU - Sethna, Vistasp
AU  - Sethna V
AD  - Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road Hadapsar, 
      Pune 411028, India.
FAU - Kampmann, Beate
AU  - Kampmann B
AD  - Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene 
      and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia; Vaccine 
      Centre, Faculty of Infectious and Tropical Diseases, London School of Hygiene and 
      Tropical Medicine, Keppel Street, London, United Kingdom.
FAU - Goldblatt, David
AU  - Goldblatt D
AD  - Great Ormond Street Institute of Child Health Biomedical Research Centre, 
      University College London, 30 Guilford Street, London, United Kingdom.
FAU - Tate, Andi
AU  - Tate A
AD  - PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.
FAU - Weiner, Debra H
AU  - Weiner DH
AD  - FHI 360, 359 Blackwell Street, Suite 200, Durham, NC, USA.
FAU - Flores, Jorge
AU  - Flores J
AD  - PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.
FAU - Alderson, Mark R
AU  - Alderson MR
AD  - PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.
FAU - Lamola, Steve
AU  - Lamola S
AD  - PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02308540
GR  - MR/R005990/1/MRC_/Medical Research Council/United Kingdom
GR  - MC_UP_A900_1122/MRC_/Medical Research Council/United Kingdom
GR  - MR/R005990/2/MRC_/Medical Research Council/United Kingdom
GR  - MC_UU_00026/2/MRC_/Medical Research Council/United Kingdom
GR  - MC_PC_17221/MRC_/Medical Research Council/United Kingdom
GR  - MC_UP_A900_1115/MRC_/Medical Research Council/United Kingdom
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191214
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (10-valent pneumococcal conjugate vaccine)
RN  - 0 (Pneumococcal Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Double-Blind Method
MH  - Female
MH  - Gambia
MH  - Humans
MH  - Immunization Programs
MH  - Immunization Schedule
MH  - Immunization, Secondary/*methods
MH  - Infant
MH  - Male
MH  - Pneumococcal Infections/immunology/*prevention & control
MH  - Pneumococcal Vaccines/*administration & dosage/adverse effects/immunology
MH  - *Vaccination
MH  - Young Adult
OTO - NOTNLM
OT  - Adult
OT  - Immunogenicity
OT  - Infant
OT  - Phase 1/2
OT  - Pneumococcal conjugate vaccine
OT  - Reactogenicity
OT  - Safety
OT  - Toddler
OT  - Tolerability
EDAT- 2019/12/18 06:00
MHDA- 2021/02/10 06:00
CRDT- 2019/12/18 06:00
PHST- 2019/05/31 00:00 [received]
PHST- 2019/08/25 00:00 [revised]
PHST- 2019/08/27 00:00 [accepted]
PHST- 2019/12/18 06:00 [pubmed]
PHST- 2021/02/10 06:00 [medline]
PHST- 2019/12/18 06:00 [entrez]
AID - S0264-410X(19)31148-X [pii]
AID - 10.1016/j.vaccine.2019.08.072 [doi]
PST - ppublish
SO  - Vaccine. 2020 Jan 10;38(2):399-410. doi: 10.1016/j.vaccine.2019.08.072. Epub 2019 
      Dec 14.