8.) The State of CT and Yale assaulted Czech
children with a vaccine that they knew would do them no good, as there is
none of the B31 version of OspA (LYMErix) in Europe.
They simply assaulted these children to see how severe
would be the adverse events.
J Infect Dis. 1994
Antibody responses to the three genomic groups of
Borrelia burgdorferi in European Lyme borreliosis.
Dressler F1, Ackermann
”The antibody responses to the three genomic groups of
Borrelia burgdorferi (B. burgdorferi sensu stricto, Borrelia garinii, and
Borrelia afzelii) were determined in 97 German patients with various
manifestations of Lyme borreliosis. The geometric mean antibody titers in
each patient group, determined by ELISA, were similar with each antigen
preparation. By Western blotting, however, patients with meningopolyneuritis
tended to respond to more spirochetal polypeptides of B. garinii, the group
2 strain, whereas those with arthritis recognized more antigens of B.
afzelii, the group 3 strain (P < .03), as did those with acrodermatitis.
Only 1 patient each with erythema migrans, arthritis, or acrodermatitis had
weak reactivity with outer surface protein A (OspA), and none responded to
OspB. It is concluded that differences among the three groups of B.
burgdorferi may result in variations in the antibody response in European
J Pediatr. 1999
a recombinant Borrelia
burgdorferi outer surface protein A vaccine against Lyme
disease in children.
Feder HM Jr1, Beran
Hoecke C, Abraham
Clercq N, Buscarino
”A recombinant lipoprotein vaccine against Lyme
disease, containing 30 microg of Borrelia burgdorferi outer surface protein
A (OspA) with aluminum adjuvant, has been shown in a large US field trial of
subjects >/=15 years of age to offer 76% efficacy against clinical Lyme
disease after 3 injections given at 0, 1, and 12 months. Lyme disease is
also an important problem in children; thus, OspA vaccine trials in children
are needed. The purpose of this study was to investigate the safety and
immunogenicity of 2 different doses of lipoprotein OspA with aluminum
adjuvant vaccine in healthy children 5 to 15 years of age in a double-blind,
randomized study. In a double-blind study, 250 children from the Czech
Republic were randomly assigned to receive 15 microg or 30 microg of
OspAvaccine at 0, 1, and 2 months. Serum samples, obtained before
vaccination and 1 month after the second and third doses, were analyzed for
antiOspA antibody. Solicited and unsolicited symptoms were collected from
diary cards. Local pain at the injection site was reported by approximately
76% of the 250 children. Headaches (after 5% to 18% of the injections) and
malaise (after 2% to 16% of the injections) were the most frequently
reported general symptoms. Local and generalized symptoms were not different
between the 15 microg and 30 microg groups, and all symptoms resolved within
4 days. Both doses were highly immunogenic, with the 30 microg dose
eliciting higher antibody levels. Seroconversion occurred in 99% of the 250
children. The OspA vaccine against Lyme disease was well tolerated and
highly immunogenic in children.”
This was not even a vaccine as previously demonstrated in the other charge
sheets. There is none of the LYMErix kind of B31 strain of Borrelia in
Europe. So, this experiment was simply “assault.”