PMID- 26445724
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20151008
LR  - 20201001
IS  - 2329-0501 (Print)
IS  - 2329-0501 (Electronic)
IS  - 2329-0501 (Linking)
VI  - 2
DP  - 2015
TI  - A phase 1 study of a heterologous prime-boost vaccination involving a truncated 
      HER2 sequence in patients with HER2-expressing breast cancer.
PG  - 15031
LID - 10.1038/mtm.2015.31 [doi]
AB  - A phase 1 clinical trial was conducted to assess the safety, tolerability, and 
      preliminary efficacy of a heterologous prime-boost strategy involving plasmid DNA 
      (pHM-GM-CSF, expressing truncated human epidermal growth factor receptor 2 (HER2) 
      and granulocyte macrophage colony-stimulation factor (GM-CSF) as a bicistronic 
      message) and an adenoviral vector (Ad-HM, containing the same modified HER2 
      sequence only), in patients with stage III-IV metastatic breast cancer expressing 
      HER2. Nine eligible subjects were divided into three cohorts based on the dosages 
      (2, 4, and 8 mg/patient/visit) of pHM-GM-CSF used as the primer, which was 
      intramuscularly injected three times at weeks 0, 2, and 4. It was followed by a 
      single injection of Ad-HM (3 x 10(9) virus particles), used as a booster, at week 
      6. During the 6-month follow-up period, adverse events (AEs), pharmacokinetics 
      and pharmacodynamics, and HER2-specific cellular and humoral immune responses 
      were evaluated. Seven cases of minor grade 1 toxicities in four of nine subjects 
      and no serious drug-related AEs were reported. HER2-specific cell-mediated or 
      humoral immunity was produced in all (100%) or three subjects (33%), 
      respectively. One subject showed a partial response, and seven subjects had 
      stable diseases. However, there were no differences in clinical tumor response 
      and HER2-specific immune responses among the cohorts. These results showed that 
      intramuscular injections of pHM-GM-CSF and Ad-HM were well tolerated and safe.
FAU - Kim, Sung-Bae
AU  - Kim SB
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine , Songpa-Gu, Seoul, Korea.
FAU - Ahn, Jin-Hee
AU  - Ahn JH
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine , Songpa-Gu, Seoul, Korea.
FAU - Kim, Jeongeun
AU  - Kim J
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine , Songpa-Gu, Seoul, Korea.
FAU - Jung, Kyung Hae
AU  - Jung KH
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine , Songpa-Gu, Seoul, Korea.
LA  - eng
PT  - Journal Article
DEP - 20150930
PL  - United States
TA  - Mol Ther Methods Clin Dev
JT  - Molecular therapy. Methods & clinical development
JID - 101624857
PMC - PMC4588449
EDAT- 2015/10/09 06:00
MHDA- 2015/10/09 06:01
PMCR- 2015/09/30
CRDT- 2015/10/08 06:00
PHST- 2015/05/19 00:00 [received]
PHST- 2015/07/08 00:00 [revised]
PHST- 2015/07/21 00:00 [accepted]
PHST- 2015/10/08 06:00 [entrez]
PHST- 2015/10/09 06:00 [pubmed]
PHST- 2015/10/09 06:01 [medline]
PHST- 2015/09/30 00:00 [pmc-release]
AID - S2329-0501(16)30043-2 [pii]
AID - 10.1038/mtm.2015.31 [doi]
PST - epublish
SO  - Mol Ther Methods Clin Dev. 2015 Sep 30;2:15031. doi: 10.1038/mtm.2015.31. 
      eCollection 2015.