PMID- 25225676
OWN - NLM
STAT- MEDLINE
DCOM- 20150416
LR  - 20211021
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 211
IP  - 4
DP  - 2015 Feb 15
TI  - Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus 
      wild-type glycoproteins in a phase I clinical trial.
PG  - 549-57
LID - 10.1093/infdis/jiu511 [doi]
AB  - BACKGROUND: Ebolavirus and Marburgvirus cause severe hemorrhagic fever with high 
      mortality and are potential bioterrorism agents. There are no available vaccines 
      or therapeutic agents. Previous clinical trials evaluated transmembrane-deleted 
      and point-mutation Ebolavirus glycoproteins (GPs) in candidate vaccines. 
      Constructs evaluated in this trial encode wild-type (WT) GP from Ebolavirus Zaire 
      and Sudan species and the Marburgvirus Angola strain expressed in a DNA vaccine. 
      METHODS: The VRC 206 study evaluated the safety and immunogenicity of these DNA 
      vaccines (4 mg administered intramuscularly by Biojector) at weeks 0, 4, and 8, 
      with a homologous boost at or after week 32. Safety evaluations included 
      solicited reactogenicity and coagulation parameters. Primary immune assessment 
      was done by means of GP-specific enzyme-linked immunosorbent assay. RESULTS: The 
      vaccines were well tolerated, with no serious adverse events; 80% of subjects had 
      positive enzyme-linked immunosorbent assay results (>/=30) at week 12. The fourth 
      DNA vaccination boosted the immune responses. CONCLUSIONS: The investigational 
      Ebolavirus and Marburgvirus WT GP DNA vaccines were safe, well tolerated, and 
      immunogenic in this phase I study. These results will further inform filovirus 
      vaccine research toward a goal of inducing protective immunity by using WT GP 
      antigens in candidate vaccine regimens. CLINICAL TRIALS REGISTRATION: 
      NCT00605514.
CI  - Published by Oxford University Press on behalf of the Infectious Diseases Society 
      of America 2014. This work is written by (a) US Government employee(s) and is in 
      the public domain in the US.
FAU - Sarwar, Uzma N
AU  - Sarwar UN
AD  - Vaccine Research Center.
FAU - Costner, Pamela
AU  - Costner P
AD  - Vaccine Research Center.
FAU - Enama, Mary E
AU  - Enama ME
AD  - Vaccine Research Center.
FAU - Berkowitz, Nina
AU  - Berkowitz N
AD  - Vaccine Research Center.
FAU - Hu, Zonghui
AU  - Hu Z
AD  - Biostatistics Research Branch, Division of Clinical Research, National Institute 
      of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, 
      Maryland.
FAU - Hendel, Cynthia S
AU  - Hendel CS
AD  - Vaccine Research Center.
FAU - Sitar, Sandra
AU  - Sitar S
AD  - Vaccine Research Center.
FAU - Plummer, Sarah
AU  - Plummer S
AD  - Vaccine Research Center.
FAU - Mulangu, Sabue
AU  - Mulangu S
AD  - Vaccine Research Center.
FAU - Bailer, Robert T
AU  - Bailer RT
AD  - Vaccine Research Center.
FAU - Koup, Richard A
AU  - Koup RA
AD  - Vaccine Research Center.
FAU - Mascola, John R
AU  - Mascola JR
AD  - Vaccine Research Center.
FAU - Nabel, Gary J
AU  - Nabel GJ
AD  - Vaccine Research Center.
FAU - Sullivan, Nancy J
AU  - Sullivan NJ
AD  - Vaccine Research Center.
FAU - Graham, Barney S
AU  - Graham BS
AD  - Vaccine Research Center.
FAU - Ledgerwood, Julie E
AU  - Ledgerwood JE
AD  - Vaccine Research Center.
CN  - VRC 206 Study Team
LA  - eng
SI  - ClinicalTrials.gov/NCT00605514
GR  - Intramural NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, N.I.H., Intramural
DEP - 20140914
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antibodies, Viral)
RN  - 0 (Cytokines)
RN  - 0 (Ebola Vaccines)
RN  - 0 (Vaccines, DNA)
RN  - 0 (Viral Vaccines)
SB  - IM
CIN - J Infect Dis. 2015 Feb 15;211(4):504-7. PMID: 25225675
MH  - Adult
MH  - Antibodies, Viral/blood/immunology
MH  - Cytokines/blood
MH  - Ebola Vaccines/administration & dosage/adverse effects/*immunology
MH  - Ebolavirus/genetics/*immunology
MH  - Enzyme-Linked Immunospot Assay
MH  - Female
MH  - Humans
MH  - Male
MH  - Marburgvirus/genetics/*immunology
MH  - Middle Aged
MH  - T-Lymphocytes/immunology
MH  - Vaccines, DNA/administration & dosage/adverse effects/*immunology
MH  - Viral Vaccines/administration & dosage/adverse effects/immunology
MH  - Young Adult
PMC - PMC4318920
OTO - NOTNLM
OT  - DNA
OT  - ebola
OT  - ebolavirus
OT  - filovirus
OT  - marburg
OT  - marburgvirus
OT  - vaccine
FIR - Gordon, Ingelise
IR  - Gordon I
FIR - Holman, Lasonji
IR  - Holman L
FIR - Mendoza, Floreliz
IR  - Mendoza F
FIR - Novik, Laura
IR  - Novik L
FIR - Saunders, Jamie
IR  - Saunders J
FIR - Zephir, Kathy
IR  - Zephir K
FIR - Desai, Niraj
IR  - Desai N
FIR - Young, Sheryl
IR  - Young S
FIR - Casazza, Joseph
IR  - Casazza J
FIR - Larkin, Brenda
IR  - Larkin B
FIR - Yamshchikov, Galina
IR  - Yamshchikov G
FIR - Vasilenko, Olga
IR  - Vasilenko O
FIR - Gomez, Phillip L
IR  - Gomez PL
FIR - Andrews, Charla
IR  - Andrews C
FIR - Conan-Cibotti, Michelle
IR  - Conan-Cibotti M
FIR - Wallace, Kimberly
IR  - Wallace K
FIR - Stein, Judy
IR  - Stein J
FIR - Sheets, Rebecca
IR  - Sheets R
FIR - Decederfelt, Hope
IR  - Decederfelt H
FIR - Starling, Judith
IR  - Starling J
FIR - Renehan, Phyllis
IR  - Renehan P
EDAT- 2014/09/17 06:00
MHDA- 2015/04/17 06:00
PMCR- 2014/09/14
CRDT- 2014/09/17 06:00
PHST- 2014/09/17 06:00 [entrez]
PHST- 2014/09/17 06:00 [pubmed]
PHST- 2015/04/17 06:00 [medline]
PHST- 2014/09/14 00:00 [pmc-release]
AID - jiu511 [pii]
AID - 10.1093/infdis/jiu511 [doi]
PST - ppublish
SO  - J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 
      Sep 14.