PMID- 28404357
OWN - NLM
STAT- MEDLINE
DCOM- 20180108
LR  - 20180207
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 35
IP  - 20
DP  - 2017 May 9
TI  - The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic 
      lupus erythematosus.
PG  - 2642-2646
LID - S0264-410X(17)30452-8 [pii]
LID - 10.1016/j.vaccine.2017.04.001 [doi]
AB  - OBJECTIVE: This study evaluated the safety and immunogenicity of qHPV vaccine in 
      SLE. METHODS: Subjects: 34 women ages 19-50years (yrs.) with mild to moderate SLE 
      & minimally active or inactive SLE received qHPV vaccine at the standard dosing 
      schedule. EXCLUSION CRITERIA: active SLE disease (SELENA-SLEDAI>2), history of 
      severe SLE disease, deep venous thrombosis, on >400mg/day of hydroxychloroquine, 
      on >15mg/day of prednisone, or active infections. Patients were monitored for 
      adverse events (AE), SLE flare, generation of thrombogenic antibodies and 
      thrombosis. Antibody (Ab) levels to HPV 6, 11, 16 & 18 were measured by HPV 
      competitive Luminex Immunoassay and Geometric Mean Titers (GMTs) were calculated 
      for each HPV type. Seroconversion was assessed for those seronegative at 
      baseline. RESULTS: The women in the study: African-American (79%), mean 
      age=38.1years, mean age at diagnosis of SLE=28.6years, 35.3% had a history of 
      smoking, 91% had 4 or more sexual partners, 50% had a history of sexually 
      transmitted diseases, and 27.3% used condoms on a regular basis. Vaccine site 
      reactions (VSRs) occurred in 62%, all mild. Ninety-seven percent experienced at 
      least 1 non vaccine adverse event (nvAE) with a total of 493 nvAEs in 33 
      patients, of which 90% were mild and none were related to vaccine or SLE. There 
      were 9 serious AEs, none were related to vaccine or SLE, all resolved. No patient 
      experienced an SLE flare, thrombosis, or generation of thrombogenic antibodies. 
      Seroconversion rate was 100% with mean GMTs comparable to Gardasil(R) package 
      insert data. CONCLUSION: In this SLE vaccine study, qHPV vaccine was generally 
      safe, well tolerated, and highly immunogenic. This clinical trial is registered 
      on Clinical Trials.gov under number, NCT01741012 and was conducted under the FDA 
      IND BB14113.
CI  - Copyright (c) 2017 Elsevier Ltd. All rights reserved.
FAU - Dhar, J Patricia
AU  - Dhar JP
AD  - Wayne State University School of Medicine, Detroit, MI, United States; Central 
      Michigan University College of Medicine, Mt. Pleasant/Saginaw, MI, United States. 
      Electronic address: pdhar@med.wayne.edu.
FAU - Essenmacher, Lynnette
AU  - Essenmacher L
AD  - Wayne State University School of Medicine, Detroit, MI, United States.
FAU - Dhar, Renee
AU  - Dhar R
AD  - Central Michigan University College of Medicine, Mt. Pleasant, MI, United States.
FAU - Magee, Ardella
AU  - Magee A
AD  - Wayne State University School of Medicine, Detroit, MI, United States.
FAU - Ager, Joel
AU  - Ager J
AD  - Wayne State University School of Medicine, Detroit, MI, United States.
FAU - Sokol, Robert J
AU  - Sokol RJ
AD  - Wayne State University School of Medicine, Detroit, MI, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT01741012
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20170409
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Viral)
RN  - 0 (Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Viral/blood
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 
      18/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - Lupus Erythematosus, Systemic/*complications
MH  - Middle Aged
MH  - Papillomavirus Infections/*prevention & control
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Cervical cancer
OT  - Cervical neoplasia
OT  - Human papillomavirus
OT  - Systemic lupus erythematosus
OT  - Vaccine immunogenicity
OT  - Vaccine safety
EDAT- 2017/04/14 06:00
MHDA- 2018/01/09 06:00
CRDT- 2017/04/14 06:00
PHST- 2017/01/12 00:00 [received]
PHST- 2017/03/09 00:00 [revised]
PHST- 2017/04/03 00:00 [accepted]
PHST- 2017/04/14 06:00 [pubmed]
PHST- 2018/01/09 06:00 [medline]
PHST- 2017/04/14 06:00 [entrez]
AID - S0264-410X(17)30452-8 [pii]
AID - 10.1016/j.vaccine.2017.04.001 [doi]
PST - ppublish
SO  - Vaccine. 2017 May 9;35(20):2642-2646. doi: 10.1016/j.vaccine.2017.04.001. Epub 
      2017 Apr 9.