Questions linger on the efficacy of the Lyme disease vaccine

A new study examines the efficacy of the Borrelia burgdorferi outer surface protein A (OspA) vaccine in a meta-analysis. [1]

 

by Daniel J. Cameron, MD MPH

The OspA vaccine trial was 78% effective at preventing a culture confirmed erythema migrans rash. But the vaccine was only 48% effective at preventing what the authors referred to as “possible Lyme disease.”

“Possible Lyme disease was defined as a flu-like illness (fever, chills, fatigue, headache, joint or muscle aches) with IgM or IgG Western blot seroconversion, or physician-diagnosed erythema migrans with negative laboratory results,” according to the LYMErixTM package insert. [2]

The vaccine trial did not address whether their OspA vaccine would prevent other complications of Lyme disease including Lyme encephalopathy or Post-Treatment Lyme Disease Syndrome.

  • The OspA vaccine raised other efficacy issues that were not addressed in the meta-analysis. [1]
  • The OspA vaccine was minimally effective in subjects vaccinated only twice. [2]
  • The efficacy of the OspA vaccine beyond the second year was unresolved. [3]
  • The OspA was not evaluated for the B. garinii and B. afzelii genospecies described in Europe. [3]
  • Moreover, the potential for autoimmunity due to molecular mimicry was not addressed. [3]

It would be helpful if these lingering questions were resolved. The meta-analysis concluded that a new-generation, multivalent OspA-based Lyme borreliosis vaccine might be more effective against all Borrelia burgdorferi sensu lato strains.

 

References:

  1. Zhao H, Bao FF, Liu A: Safety, immunogenicity, and efficacy of Borrelia burgdorferi outer surface protein A (OspA) vaccine: A meta-analysis. J Infect Dev Ctries 2017, 11(1):1-9.
  2. FDA Package Insert – LYMErixTM
    http://www.fda.gov/ohrms/DOCKETS/…/01/briefing/3680b2_03.pdf
  3. Steere AC, Sikand VK, Meurice F, Parenti DL, Fikrig E, Schoen RT, Nowakowski J, Schmid CH, Laukamp S, Buscarino C et al: Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group. N
    Engl J M


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