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Randomized Comparison of Early and Late Vaccination with Inactivated Poliovirus Vaccine After Allogeneic BMT

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Randomized Comparison of Early and Late Vaccination with Inactivated Poliovirus Vaccine After Allogeneic BMT Bone Marrow Transplantation, (1997) 20, 663–668 1997 Stockton Press All rights reserved 0268–3369/97 $12.00 Randomized comparison of early and late vaccination with inactivated poliovirus vaccine after allogeneic BMT T Parkkali1, M Stenvik2, T Ruutu1, T Hovi2, L Volin1 and P Ruutu2 1Division of Haematology, Department of Medicine, Helsinki University Central Hospital and 2National Public Health Institute, Helsinki, Finland Summary: immune memory, and antibodies to recall antigens gradu- ally disappear over years. Forty-five adult HLA-matched sibling BMT recipients The proportion of allogeneic BMT recipients with were randomized to receive inactivated poliovirus vac- poliovirus immunity declines during long-term follow-up.3–6 cine (IPV) at 6, 8 and 14 months (early group, n = 23) The risk for polio infection is low in developed countries. or at 18, 20 and 26 months after BMT (late group, n = However, small outbreaks of poliomyelitis involving heal- 22). Ninety-five percent of the early group patients had thy adults and children have occurred during the last 12 protective antibody titres of >4 to poliovirus type 1 years.7,8 Inactivated poliovirus vaccine (IPV) has been (PV1), poliovirus type 2 (PV2) and poliovirus type 3 shown to be effective and safe among BMT recipients,3–5 (PV3) by a microneutralization assay prior to the first and recently the Infectious Diseases Working Party of the vaccination, at 6 months after BMT. The corresponding European Group for Blood and Marrow Transplantation has proportion for the late group patients was only 67% at recommended immunization of BMT recipients with IPV.9 18 months. The antibody responses 1 month after each In order to find out if early vaccination of adult allo- of the three IPV doses were similar in the two vacci- geneic BMT recipients against poliomyelitis is as effective nation groups, except that four-fold responses occurred as that given later, a prospective, randomized study with more frequently after the first dose to PV2 and PV3 in inactivated poliovirus vaccine was carried out, comparing the late group. All patients had a protective antibody two different vaccination schedules. titre to all poliovirus serotypes 1 and 22 months after the third vaccine dose, except one patient in the early group who lacked antibodies to PV3 at 22 months. Materials and methods Acute GVHD accelerated the decrease of poliovirus antibody titres prior to vaccination but had no influence Patients on vaccination response. Chronic GVHD neither influ- enced the patient’s ability to retain poliovirus antibodies Fifty-five consecutive adults (age >16 years) who had prior to vaccination nor impaired responses to vacci- received a bone marrow transplant from a sibling donor nations. A vaccination schedule consisting of three IPV between January 1985 and November 1989 at Helsinki Uni- doses was equally immunogenic when started at 6 or 18 versity Central Hospital were randomized into two vacci- months after allogeneic BMT. nation groups at 5 months after transplantation. Informed Keywords: inactivated poliovirus vaccine; BMT consent was obtained from the patients before randomiz- recipients ation. The vaccination program started either at 6 (early group) or 18 (late group) months after BMT. Eight patients died before the intended vaccinations started (two in the early vaccination group and six in the late group). One Immune reconstitution after allogeneic BMT from cells patient in the early group was treated at another hospital originating from the donor takes 1–2 years in healthy and could not be vaccinated, and one patient in the late recipients and even longer in patients with chronic group relapsed. Characteristics of the remaining 45 patients 1,2 GVHD. The numbers of different lymphocyte types in (23 in the early group and 22 in the late group) are blood involved in immunological functions usually nor- presented in Table 1. malize during the first 6–12 months after BMT. Serum Patients received a bone marrow graft from an HLA- immunoglobulin levels, except that of IgA, become normal identical, MLC-negative sibling donor. T cell depletion was 2 during the 12–18 months after BMT. However, the con- not done. The recipients with haematological malignancy ditioning treatment prior to BMT causes loss of specific were conditioned with cyclophosphamide (60 mg/kg body weight intravenously on 2 consecutive days) and total body irradiation (total dose from 11 to 12 Gy in five or six frac- tions on 5 consecutive days) or cyclophosphamide and bus- Correspondence: Dr T Parkkali, Division of Haematology, Department of Medicine, Helsinki University Central Hospital, Haartmaninkatu 4, FIN- ulphan (4 mg/kg on 4 consecutive days). Four patients with 00290 Helsinki, Finland chronic myeloid leukaemia also received one infusion of Received 26 February 1997; accepted 23 June 1997 daunorubicin, 60 mg/m2, and splenic irradiation. The Response to poliovirus vaccine after allogeneic BMT T Parkkali et al 664 Table 1 Characteristics of the patients Early group Early group Late group Total No. of patients 23 22 BMT 6 8 1415 20 24 36 Age of patients months Median (years) 31 30 Late group Range (years) 16–48 18–49 Age of donors Median (years) 29 31 BMT 6 12 18 20 2627 32 36 48 Range (years) 12–49 20–59 months Sex Male 12 12 Female 11 10 = Blood sample Primary disease AML 11 9 = Inactivated poliovirus vaccine ALL 5 2 CML 2 8 Figure 1 Schedule for blood samples and vaccinations after BMT. Multiple myeloma 3 2 Burkitt’s lymphoma 0 1 Lymphoblastic lymphoma 1 0 Severe aplastic anaemia 1 0 (Pneumovax; Merck, Sharp and Dohme, West Point, Conditioning regimen PA,USA), and with meningococcal polysaccharide vaccine CY + TBI 18 19 (Mencevax ACW Y; Smith Kline RIT, Rixensart, CY + BU 4 3 135 Cy + total nodal irradiation 1 Belgium). GVHD prophylaxis CsA 5 8 Serum samples CsA + a short course of MTX 17 13 Corticosteroids + MTX 1 1 Blood samples were collected from 42 of the 45 donors, Acute GVHD 14 (61%) 13 (59%) from 41 of the 45 patients before BMT, and from the Chronic GVHD 13 (57%) 9 (41%) patients after BMT according to the schedule in Figure 1. During the vaccination program and the first year after the third vaccine dose, blood specimens taken within 1 week prior to or 3 weeks after the scheduled time-point were patient transplanted for aplastic anaemia was conditioned included in the analyses. During the second year after com- with cyclophosphamide 50 mg/kg on 4 consecutive days pleting the vaccination schedule blood samples taken one and total nodal irradiation 8.0 Gy in four fractions on 2 month before or after the scheduled time were considered consecutive days. Acute GVHD was defined according to adequate. One of the late group patients was vaccinated Thomas et al10 and treated with methylprednisolone, start- against polio between 6 and 12 months after BMT. Speci- ing with a dose of 2 mg/kg/day or 10–15 mg/kg/day, mens drawn from this patient after vaccination were depending on the severity of GVHD. Chronic GVHD was excluded from the analysis of poliovirus antibodies. defined according to Shulman et al11 and treated with methylprednisolone alone or in combination with azathio- Neutralizing antibodies to poliovirus prine or thalidomide. The standard microneutralization assay used was based on the standard procedures described by Albrecht et al.12 Vaccination Serum specimens were heat inactivated (30 min at 56°C) The 23 patients in the early group were vaccinated at 6, 8 and serially diluted on microtitre plates (Nunclon Microtest and 14 months and the 22 patients in the late group at 18, 96-well plates). An equal volume of pretitrated virus 20 and 26 months after BMT with inactivated trivalent dilution (corresponding to 100 TCID50) was added, and the poliovirus vaccine (Polio Novum, RIVM, Bilthoven, The plates were sealed. The following virus strains were used: Netherlands) (Figure 1). One 1.0 ml dose of the vaccine poliovirus type 1 strain Mahoney (PV1), poliovirus type 2 contained at least 40–8-32 D-antigen units for poliovirus strain MEF-1 (PV2) and poliovirus type 3 strain Saukett types 1, 2 and 3, respectively. The vaccine was adminis- (PV3). After overnight incubation at +36°C, 15 000 Vero tered subcutaneously. Three doses of tetanus toxoid vaccine cells were added per well, and the resealed plates were (manufactured by National Public Health Institute, Hel- incubated at 36°C. Virus growth was determined by sinki, Finland) were given with the same schedule as the microscopy at 6 days. The highest dilution with complete polio vaccine. At the time of the first dose of polio vaccine inhibition of cytopathogenic effect was considered the end- the patients received Haemophilus influenzae type b poly- point titre. A standard serum preparation, calibrated accord- saccharide–diphtheria toxoid conjugate vaccine (ProHIBIT; ing to an international reference serum, was included as a Connaught Laboratories, Swiftwater, PA, USA). At the reference in each assay. For statistical calculations, titres time of the second dose of polio vaccine the recipients were ,4 were given an arbitrary value of 2 and titres .4096 a immunized with pneumococcal polysaccharide vaccine value of 8192. Poliovirus antibody titres >4 were con- Response to poliovirus vaccine after allogeneic BMT T Parkkali et al 665 sidered protective. A four-fold or higher increase in anti- of the poliovirus antibodies between the groups during the body titre was used as the criterion for response. 22 months after completing the vaccinations (Figure 3). The first dose of poliovirus vaccine induced a four-fold or Statistical methods higher increase in antibody titre to PV2 and PV3 in a larger proportion in the late group than in the early group patients Fisher’s exact test was used to compare the frequency of (Table 3).
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