PMID- 15336473
OWN - NLM
STAT- MEDLINE
DCOM- 20041108
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 26
IP  - 7
DP  - 2004 Jul
TI  - A randomized, open-label study of the immunogenicity and reactogenicity of three 
      lots of a combined typhoid fever/hepatitis A vaccine in healthy adults.
PG  - 1084-91
AB  - BACKGROUND: Travelers are often advised to receive both the typhoid fever and 
      hepatitis A virus (HAV) vaccines, particularly when going to areas where the 2 
      diseases are endemic. Thus, combined administration of these vaccines could make 
      immunization more acceptable by reducing the number of injections needed. 
      OBJECTIVE: This study compared the safety profiles and immunogenicity of 3 
      batches of a combined typhoid fever/HAV vaccine administered using a dual-chamber 
      bypass syringe. METHODS: This randomized, open-label study was conducted at 2 
      university-based travel clinics in Germany and Austria. Subjects received a 
      single IM injection from 1 of 3 batches of the combined vaccine. Blood samples 
      were drawn immediately before and 28 days after vaccination to evaluate the 
      response to the 2 antigens by assessing geometric mean titers (GMTs) and rates of 
      seroconversion and seroprotection. Subjects recorded all adverse events (AEs) 
      occurring during the study period in a diary. RESULTS: Six hundred ten healthy 
      adults were enrolled in the study. Twenty-eight days after vaccination, 90.6% of 
      the study population had protective typhoid Vi antibody titers (> or = 1 
      microg/mL) and 100% had protective HAV antibody titers (> or = 20 mIU/mL). 
      Seroconversion rates and GMTs were not significantly different between the 3 
      batches. There were no differences with regard to local or systemic AEs between 
      the 3 batches of vaccine. There were no immediate adverse reactions (within 30 
      minutes of vaccination) and no serious AEs related to vaccination. Of 609 
      evaluable subjects (1 was lost to follow-up after the first visit), 555 (91.1%) 
      experienced > or = 1 local reaction within the first 7 days after vaccination, 
      mainly pain at the injection site (550 [90.3%]), but only 26 (4.3%) described 
      this pain as severe. Vaccine-related headache and mild to moderate asthenia were 
      each reported by 54 subjects (8.9%). Symptoms resolved spontaneously in all 
      cases. CONCLUSIONS: The 3 batches of the combined typhoid fever/HAV vaccine 
      administered by dual-chamber bypass syringe were equally well tolerated and 
      effective in healthy adults, and did not differ significantly in terms of GMTs or 
      seroconversion rates.
FAU - Loebermann, Micha
AU  - Loebermann M
AD  - Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, 
      University of Rostock, D-18057 Rostock, Germany. 
      micha.loebermann@medizin.uni-rostock.de
FAU - Kollaritsch, Herwig
AU  - Kollaritsch H
FAU - Ziegler, Tom
AU  - Ziegler T
FAU - Rendi-Wagner, Pamela
AU  - Rendi-Wagner P
FAU - Chambonneau, Laurent
AU  - Chambonneau L
FAU - Dumas, Rafaele
AU  - Dumas R
FAU - Lafrenz, Michael
AU  - Lafrenz M
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antibodies, Viral)
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Typhoid-Paratyphoid Vaccines)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral/isolation & purification
MH  - Austria
MH  - Drug Administration Schedule
MH  - Female
MH  - Germany
MH  - Hepatitis A/immunology/*prevention & control
MH  - Hepatitis A Vaccines/*administration & dosage
MH  - Humans
MH  - Male
MH  - Typhoid Fever/immunology/*prevention & control
MH  - Typhoid-Paratyphoid Vaccines/*administration & dosage
MH  - Vaccines, Combined/*administration & dosage/adverse effects
EDAT- 2004/09/01 05:00
MHDA- 2004/11/09 09:00
CRDT- 2004/09/01 05:00
PHST- 2004/03/31 00:00 [accepted]
PHST- 2004/09/01 05:00 [pubmed]
PHST- 2004/11/09 09:00 [medline]
PHST- 2004/09/01 05:00 [entrez]
AID - S0149291804901804 [pii]
AID - 10.1016/s0149-2918(04)90180-4 [doi]
PST - ppublish
SO  - Clin Ther. 2004 Jul;26(7):1084-91. doi: 10.1016/s0149-2918(04)90180-4.