Safety and immunogenicity profile of a recombinant outer-surface protein A Lyme disease vaccine: clinical trial of a 3-dose schedule at 0, 1, and 2 months.

Abstract

OBJECTIVES:

This study compared the tolerability of a Lyme disease vaccine administered intramuscularly at 0 and 1 months with that of a vaccine administered at 0, 1, and 2 months to determine (1) whether adding a third dose of vaccine 1 month after the second would affect the safety profile, and (2) whether a shortened vaccination schedule of 0, 1, and 2 months would provide an immune response similar to that obtained with vaccine administered at 0, 1, and 12 months.

BACKGROUND:

An efficacy trial of a Lyme disease vaccine had demonstrated safety and efficacy against definite (clinically manifested and laboratory-confirmed) Lyme disease after 3 doses at 0, 1, and 12 months and resulted in 90% of subjects having titers > or =1400 enzyme-linked immunosorbent assay units (EL.U)/mL (the proposed seroprotective level for 1 tick season).

METHODS:

This multicenter, open-label, prospective, randomized study assessed the safety and efficacy of different doses of a recombinant outer-surface protein A (OspA) vaccine in 956 volunteers aged 17 to 72 years from 3 Lyme disease-endemic sites. Blood samples were collected at months 0, 2, 3, 12, and 13 to assess total immunoglobulin-G anti-OspA titers.

RESULTS:

Most adverse events were transient and mild to moderate. The geometric mean antibody titer increased 2.8-fold from month 2 (1786 EL.U/mL to 4842 EL.U/mL), and approximately 90% of the volunteers had a titer > or =1400 and 99% had a titer > or =400 EL.U/mL (the mini- mum seroprotective level at any given time) after the third dose. An antibody kinetics model predicts that protection would last for a typical tick-transmission season.

CONCLUSIONS:

In volunteers aged 17 to 72 years, 3 doses of vaccine administered in 2 months was well tolerated, more immunogenic than 2 doses, and provided a higher probability of protection before exposure or travel to Lyme disease-endemic areas.

• Authors: R T Schoen, V K Sikand, M C Caldwell, C Van Hoecke, M Gillet, C Buscarino, D L Parenti
• Journal: Clinical therapeutics (Clin Ther) Vol. 22 Issue 3 Pg. 315-25 (Mar 2000) ISSN: 0149-2918 [Print] United States
• PMID: 10963286 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antigens, Surface
• Bacterial Outer Membrane Proteins
• Bacterial Vaccines
• Lipoproteins
• Lyme Disease Vaccines
• OspA protein
• Vaccines, Synthetic

Topics

• Adolescent
• Adult
• Aged
• Antigens, Surface (immunology)
• Bacterial Outer Membrane Proteins (immunology)
• Bacterial Vaccines
• Drug Administration Schedule
• Humans
• Lipoproteins
• Lyme Disease Vaccines (administration & dosage, adverse effects, immunology)
• Middle Aged
• Prospective Studies
• Vaccines, Synthetic (immunology)