A randomized, open-label study of the immunogenicity and reactogenicity of three lots of a combined typhoid fever/hepatitis A vaccine in healthy adults.

Abstract

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.

• Authors: Micha Loebermann, Herwig Kollaritsch, Tom Ziegler, Pamela Rendi-Wagner, Laurent Chambonneau, Rafaele Dumas, Michael Lafrenz
• Journal: Clinical therapeutics (Clin Ther) Vol. 26 Issue 7 Pg. 1084-91 (Jul 2004) ISSN: 0149-2918 [Print] United States
• PMID: 15336473 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Viral
• Hepatitis A Vaccines
• Typhoid-Paratyphoid Vaccines
• Vaccines, Combined

Topics

• Adult
• Antibodies, Viral (isolation & purification)
• Austria
• Drug Administration Schedule
• Female
• Germany
• Hepatitis A (immunology, prevention & control)
• Hepatitis A Vaccines (administration & dosage)
• Humans
• Male
• Typhoid Fever (immunology, prevention & control)
• Typhoid-Paratyphoid Vaccines (administration & dosage)
• Vaccines, Combined (administration & dosage, adverse effects)