Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial.
Adjuvants, Immunologic
/ administration & dosage
Adult
Aged
Antibodies, Viral
/ metabolism
Antigens, Viral
/ immunology
Combined Modality Therapy
Drug Therapy
/ methods
Female
Herpes Zoster Vaccine
/ administration & dosage
Humans
Male
Middle Aged
Neoplasms
/ drug therapy
Treatment Outcome
Vaccines, Synthetic
Young Adult
herpes zoster vaccine
immunogenicity
immunosuppressive chemotherapy
patients with solid tumors
safety
Journal
Cancer
ISSN: 1097-0142
Titre abrégé: Cancer
Pays: United States
ID NLM: 0374236
Informations de publication
Date de publication:
15 04 2019
15 04 2019
Historique:
received:
30
07
2018
revised:
02
10
2018
accepted:
18
10
2018
pubmed:
2
2
2019
medline:
15
1
2020
entrez:
2
2
2019
Statut:
ppublish
Résumé
The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle. In this phase 2/3 observer-blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1-2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8-30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 There were 232 participants in the total vaccinated cohort, 185 participants in the according-to-protocol cohort for humoral immunogenicity, and 58 participants in the according-to-protocol cohort for cell-mediated immunogenicity. Postvaccination anti-gE antibody concentrations, gE-specific CD4 RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell-mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.
Sections du résumé
BACKGROUND
The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle.
METHOD
In this phase 2/3 observer-blind, multicenter study (NCT01798056), patients with STs who were ≥18 years of age were randomized (1:1) to receive 2 doses of RZV or placebo 1-2 months apart and stratified (4:1) according to the timing of the first dose with respect to the start of a chemotherapy cycle (first vaccination 8-30 days before the start or at the start [±1 day] of a chemotherapy cycle). Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4
RESULTS
There were 232 participants in the total vaccinated cohort, 185 participants in the according-to-protocol cohort for humoral immunogenicity, and 58 participants in the according-to-protocol cohort for cell-mediated immunogenicity. Postvaccination anti-gE antibody concentrations, gE-specific CD4
CONCLUSION
RZV was immunogenic in patients with STs receiving immunosuppressive chemotherapies. Humoral and cell-mediated immune responses persisted 1 year after vaccination. No safety concerns were identified.
Identifiants
pubmed: 30707761
doi: 10.1002/cncr.31909
pmc: PMC6766894
doi:
Substances chimiques
Adjuvants, Immunologic
0
Antibodies, Viral
0
Antigens, Viral
0
Herpes Zoster Vaccine
0
Vaccines, Synthetic
0
Banques de données
ClinicalTrials.gov
['NCT01798056']
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1301-1312Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
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