scholarly journals Imunogenisitas dan Keamanan vaksin Tetanus Difteri (Td) pada Remaja sebagai salah satu upaya mencegah Reemerging Disease di Indonesia

Sari Pediatri ◽  
2016 ◽  
Vol 15 (3) ◽  
pp. 141 ◽  
Author(s):  
Eddy Fadlyana ◽  
Kusnandi Rusmil ◽  
Herry Garna ◽  
Iwin Sumarman ◽  
Soenarjati Soedigo Adi ◽  
...  
Keyword(s):  
Geometric Mean ◽  
Geometric Mean Titer ◽  
Double Blind ◽  
Immunosorbent Assays

Latar belakang. Di Indonesia berpotensi terjadi reemerging disease difteri akibat belum ada program imunisasi ulang yang berkesinambungan pada remaja.Tujuan. Menilai imunogenisitas dan keamanan vaksin tetanus difteri (Td) yang diberikan sebagai imunisasi ulang pada remaja.Metode. Uji klinis randomized double-blind controlled dilakukan terhadap 296 pelajar remaja sehat di kota Bandung, usia 10–18 tahun, pada September 2007–September 2008. Didapatkan 296 remaja sebagai subjek penelitian, dibagi dalam 2 kelompok secara acak sederhana. Kelompok I mendapat vaksin Td 0,5 mL intramuskular. Kelompok II mendapat vaksin TT sebagai kontrol. Pemeriksaan kadar antibodi anti difteri dan anti tetanus dilakukan sebelum dan 1 bulan setelah imunisasi menggunakan teknik enzyme-linked immunosorbent assays (ELISAs). Data keamanan dikumpulkan sampai 1 bulan pasca imunisasi menggunakan buku harianHasil. Konsentrasi antibodi seroproteksi (>0,1 IU/mL) terhadap difteri dan tetanus mencapai 93,2% dan 100,0%. The geometric mean titer (GMT) terhadap difteri meningkat dari 0,0618 IU/mL menjadi 0,7583 IU/mL (p<0,001), dan terhadap tetanus meningkat dari 0,4413 IU/mL ke 14,4054 IU/mL (p<0,001). Nyeri pada tempat suntikan terjadi pada 20,3% kelompok Td dan 18,2% pada TT (p=0,028). Demam >37,5°C hanya terjadi pada sedikit subjek dari kedua kelompok (rentang Td: 0,7-4,7%; rentang TT: 3,4–6,7%). Tidak terdapat reaksi kejadian ikutan pasca imunisasi serius dan dapat ditoleransi dengan baik.Kesimpulan. Imunisasi ulang Td meningkatkan kadar antibodi protektif terhadap difteri dan tetanus, serta aman diberikan pada remaja.

scholarly journals Efficacy and Safety of a 3-Antigen (Pre-S1/Pre-S2/S) Hepatitis B Vaccine: Results of a Phase 3 Randomized Clinical Trial in the Russian Federation

2020 ◽  
Author(s):  
Elena V Esaulenko ◽  
Aleksey A Yakovlev ◽  
Genady A Volkov ◽  
Anastasia A Sukhoruk ◽  
Kirill G Surkov ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Geometric Mean ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Antigen Vaccine ◽  
Single Antigen ◽  
Antibody Titers ◽  
The Russian Federation ◽  
The Difference ◽  
Mean Concentration

Abstract Background This study compares the immunogenicity and safety of a 3-antigen (S/pre-S1/pre-S2) hepatitis B (HepB) vaccine (3AV), to a single antigen vaccine (1AV) in adults to support the registration of 3AV in Russia. Methods We conducted a randomized, double-blind, comparative study of 3-dose regimens of 3AV (10 μg) and 1AV (20 µg) in adults aged 18–45 years. We evaluated immunogenicity based on hepatitis B surface (HBs) antibody titers at days 1, 28, 90, 180, and 210, adverse and serious adverse events (SAEs) to study day 210. The primary outcome was based on the difference in rates of seroconversion at day 210 (lower bound 95% confidence interval [CI]: &gt; − 4%). Secondary outcomes were seroprotection rates (SPR), defined as anti-HBs ≥10 mIU/mL and anti-HBs geometric mean concentration (GMC). Results Rate of seroconversion in 3AV (100%) was noninferior to 1AV (97.9%) at study day 210 (difference: 2.1%, 95% CI: −2.0, 6.3%]) but significantly higher at study day 28. SPR at study day 210 was &gt;97% in both arms. Anti-HBs titers were significantly higher at study days 90 (P = .001) and 180 (P = .0001) with 3AV. Sex, age, and body mass index (BMI) had no impact on anti-HBs titers. The rates of local reactions related to vaccination were similar between vaccine arms (3AV vs 1AV) after the first (30% vs 18.8%, P = .15), second (20.0% vs 14.6%, P = .33), and third vaccination (14.9% vs 23.4%, P = .22). No SAEs were reported. Conclusions 3AV was noninferior to 1AV. 3AV induced high SPR, and there were no safety concerns. Clinical Trials Registration. NCT04209400.

scholarly journals Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome

2021 ◽  
pp. 1-10
Author(s):  
Glenn M. Chertow ◽  
Gerald B. Appel ◽  
Sharon Andreoli ◽  
Sripal Bangalore ◽  
Geoffrey A. Block ◽  
...  
Keyword(s):  
Kidney Function ◽  
Alport Syndrome ◽  
Genetic Disorder ◽  
Geometric Mean ◽  
Genetic Diagnosis ◽  
Significant Loss ◽  
The European Union ◽  
Phase 3 ◽  
Double Blind ◽  
Histologic Diagnosis

<b><i>Introduction:</i></b> Alport syndrome is a rare genetic disorder that affects as many as 60,000 persons in the USA and a total of 103,000 persons (&#x3c;5 per 10,000) in the European Union [1, 2]. It is the second most common inherited cause of kidney failure and is characterized by progressive loss of kidney function that often leads to end-stage kidney disease. Currently, there are no approved disease-specific agents for therapeutic use. We designed a phase 3 study (CARDINAL; NCT03019185) to evaluate the safety, tolerability, and efficacy of bardoxolone methyl in patients with Alport syndrome. <b><i>Methods:</i></b> The CARDINAL phase 3 study is an international, multicenter, double-blind, placebo-controlled, randomized registrational trial. Eligible patients were of ages 12–70 years with confirmed genetic or histologic diagnosis of Alport syndrome, eGFR 30–90 mL/min/1.73 m<sup>2</sup>, and urinary albumin to creatinine ratio (UACR) ≤3,500 mg/g. Patients with B-type natriuretic peptide values &#x3e;200 pg/mL at baseline or with significant cardiovascular histories were excluded. Patients were randomized 1:1 to bardoxolone methyl or placebo, with stratification by baseline UACR. <b><i>Results:</i></b> A total of 371 patients were screened, and 157 patients were randomly assigned to receive bardoxolone methyl (<i>n</i> = 77) or placebo (<i>n</i> = 80). The average age at screening was 39.2 years, and 23 (15%) were &#x3c;18 years of age. Of the randomized population, 146 (93%) had confirmed genetic diagnosis of Alport syndrome, and 62% of patients had X-linked mode of inheritance. Mean baseline eGFR was 62.7 mL/min/1.73 m<sup>2</sup>, and the geometric mean UACR was 141.0 mg/g. The average annual rate of eGFR decline prior to enrollment in the study was −4.9 mL/min/1.73 m<sup>2</sup> despite 78% of the patient population receiving ACE inhibitor (ACEi) or ARB therapy. <b><i>Discussion/Conclusion:</i></b> CARDINAL is one of the largest interventional, randomized controlled trials in Alport syndrome conducted to date. Despite the use of ACEi or ARB, patients were experiencing significant loss of kidney function prior to study entry.

scholarly journals Respon Imun Itik Bali Pascavaksinasi Newcastle Disease

2018 ◽  
pp. 127
Author(s):  
Anindya Novitasari ◽  
Ida Bagus Kade Suardana ◽  
I Putu Sampurna
Keyword(s):  
Newcastle Disease ◽  
Geometric Mean ◽  
Geometric Mean Titer

Penelitian ini bertujuan untuk mengetahui respon imun itik terhadap vaksinasi Newcastle Disease (ND), serta waktu yang diperlukan agar terbentuk titer antibodi yang protektif. Penelitian menggunakan rancangan acak lengkap (RAL) dengan waktu sebagai perlakuan. Objek penelitian menggunakan serum itik Bali. Pengambilan darah pravaksinasi dilakukan pada umur tiga minggu, pada umur empat minggu dilakukan vaksinasi secara sub kutan. Pengambilan darah pascavaksinasi dilakukan empat kali dengan interval waktu satu minggu, diambil dari vena tibialis cranial dengan spuite satu cc, dan serum dipindahkan ke dalam tabung Eppendorf. Titer antibodi diuji dengan uji Hemaglutination inhibition (HI), dan dinyatakan dalam Geometric Mean Titer (GMT) dengan satuan Log 2. Rerata titer antibodi pravaksinasi adalah 0,83±0,408 Log 2. Sedangkan rerata titer antibodi minggu ke-1,2,3 dan 4 pasca vaksinasi adalah 2±0,632 Log 2, 5,5±1,225 Log 2, 1,2±0,983   Log 2, dan 0,16±0,408 Log 2. Dapat disimpulkan titer antibodi protektif (?2?) pada minggu ke-2 pascavaksinasi.

scholarly journals A phase 1 study of single and repeat oral doses of GSK3439171A, a highly selective H-PGDS inhibitor, in healthy adult participants

2021 ◽  
Author(s):  
Thomas Haws ◽  
Nilay Thakkar ◽  
Summer Goodson ◽  
Caroline Sychterz ◽  
Nisha George ◽  
...  
Keyword(s):  
Therapeutic Potential ◽  
Drug Hypersensitivity ◽  
Phase 1 ◽  
Geometric Mean ◽  
Human Study ◽  
Study Drug ◽  
Prostaglandin D2 ◽  
Dose Escalation Study ◽  
Double Blind ◽  
Oral Doses

Aim: Prostaglandin D2 (PGD2) is implicated in the pathophysiology of inflammatory diseases. GSK3439171A is a potent, reversible, and highly selective azetidine urea inhibitor of haematopoietic prostaglandin D synthase (H-PGDS, a key promoter of PGD2 production in several inflammatory cell types). Based on favourable preclinical data, we performed a first-time-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK3439171A, and the effect of food on these parameters. Methods: This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study. Single and repeat oral doses of GSK3439171A were administered to healthy males aged 18–65 years. Levels of inflammatory markers including tetranor-prostaglandin D metabolite (tPGDM) were measured in urine samples. Results: Sixty-six participants were enrolled, with 57 receiving GSK3439171A. Single doses (5–180 mg) and repeat once-daily doses (5 and 11 mg for 14 days; 40 mg for 7 days) were administered. Seven participants (12%) had adverse events (AEs) related to study drug, mainly drug hypersensitivity (n=4 [7%]; non-serious, transient skin rash). There were no serious AEs (SAEs) or clinically significant changes in vital signs, electrocardiogram, or laboratory parameters. Dose-proportional increases in Cmax and AUC(0–inf) were observed, and the geometric mean half-life of GSK3439171A was up to 12 hours. Results were similar when GSK3439171A was taken with or without food. No consistent suppression of tPGDM levels was observed. Conclusion: GSK3439171A was well tolerated in healthy participants and there were no SAEs. Selective inhibition of H-PGDS offers therapeutic potential for muscle-related disorders (e.g. Duchenne Muscular Dystrophy) and muscular recovery following injury.

scholarly journals The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old

2020 ◽  
Vol 22 ◽  
pp. 02001
Author(s):  
O.P. Kovtun ◽  
V.V. Romanenko ◽  
I.V. Feldblum ◽  
A.U. Sabitov ◽  
A.V. Ankudinova
Keyword(s):  
Influenza Vaccine ◽  
Pediatric Population ◽  
Seroconversion Rate ◽  
Geometric Mean ◽  
Age Groups ◽  
Quadrivalent Vaccine ◽  
Seroprotection Rate ◽  
Double Blind ◽  
Care Workers ◽  
B Virus

Russian health care workers currently use trivalent influenza vaccines with a strain of a single lineage of type B virus. The purpose of our study was to evaluate the immunogenicity of an adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old. We compared this new vaccine to a trivalent Grippol Plus vaccine in terms of immunogenicity against certain strains of influenza virus. A multicenter double-blind randomized controlled clinical study was conducted in 440 pediatric subjects (age groups: 6 to 11; 12 to 17 y.o.); 221 subjects received Grippol Quadrivalent, 219 – Grippol Plus. Vaccine immunogenicity was evaluated by seroprotection rate (SPR), seroconversion rate (SCR), geometric mean titer (GMT) of antibodies, and an X-fold rise in antibodies level (↑GMT). Antibodies quantification was done using hemagglutination inhibition assay (HAI) in serial serum dilutions. No significant differences were found between the two vaccines’ performance against A(H1N1), A(H3N2) strains or Victoria B virus. With respect to type A virus, both vaccines satisfied three of CPMP criteria (SPR, SCR, ↑GMT). With respect to Victoria B virus, the two vaccines met but one CPMP criterion (↑GMT). The immunogenicity against Yamagata B virus was evaluated only for Grippol Quadrivalent vaccine which met two of CPMP requirements (SCR, ↑GMT). Our findings suggest that in terms of its prophylactic efficiency, Grippol Quadrivalent vaccine is no inferior to the Grippol Plus one.

scholarly journals Double-Blind, Randomized, Placebo-Controlled Phase II Dose-Finding Study To Evaluate High-Dose Rifampin for Tuberculous Meningitis

2018 ◽  
Vol 62 (12) ◽  
Author(s):  
S. Dian ◽  
V. Yunivita ◽  
A. R. Ganiem ◽  
T. Pramaesya ◽  
L. Chaidir ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase Ii ◽  
Tuberculous Meningitis ◽  
Standard Dose ◽  
Geometric Mean ◽  
Phase Iii ◽  
High Dose ◽  
Treatment Area ◽  
Double Blind ◽  
Time Curve

ABSTRACT High doses of rifampin may help patients with tuberculous meningitis (TBM) to survive. Pharmacokinetic pharmacodynamic evaluations suggested that rifampin doses higher than 13 mg/kg given intravenously or 20 mg/kg given orally (as previously studied) are warranted to maximize treatment response. In a double-blind, randomized, placebo-controlled phase II trial, we assigned 60 adult TBM patients in Bandung, Indonesia, to standard 450 mg, 900 mg, or 1,350 mg (10, 20, and 30 mg/kg) oral rifampin combined with other TB drugs for 30 days. The endpoints included pharmacokinetic measures, adverse events, and survival. A double and triple dose of oral rifampin led to 3- and 5-fold higher geometric mean total exposures in plasma in the critical early days (2 ± 1) of treatment (area under the concentration-time curve from 0 to 24 h [AUC0–24], 53.5 mg · h/liter versus 170.6 mg · h/liter and 293.5 mg · h/liter, respectively; P < 0.001), with proportional increases in cerebrospinal fluid (CSF) concentrations and without an increase in the incidence of grade 3 or 4 adverse events. The 6-month mortality was 7/20 (35%), 9/20 (45%), and 3/20 (15%) in the 10-, 20-, and 30-mg/kg groups, respectively (P = 0.12). A tripling of the standard dose caused a large increase in rifampin exposure in plasma and CSF and was safe. The survival benefit with this dose should now be evaluated in a larger phase III clinical trial. (This study has been registered at ClinicalTrials.gov under identifier NCT02169882.)

Evaluation of the Pertussis Components of Diphtheria-Tetanus-Pertussis Vaccine

PEDIATRICS ◽  
1983 ◽  
Vol 71 (2) ◽  
pp. 200-205
Author(s):  
M. Dianne Murphy ◽  
Jeane Rasnack ◽  
Harold D. Dickson ◽  
Marc Dietch ◽  
Philip A. Brunell
Keyword(s):  
Pertussis Vaccine ◽  
Geometric Mean ◽  
Aluminum Phosphate ◽  
The United States ◽  
Geometric Mean Titer ◽  
Whole Cell ◽  
Pertussis Antigen ◽  
Dtp Vaccine ◽  
Local Reactions ◽  
The Individual

The adjuvant and antigen components of the pertussis fraction of diphtheria-tetanus-pertussis (DTP) vaccine were evaluated. Four preparations of DTP vaccine composed of either whole cell (Wc) or extracted (E) pertussis antigen combined with either an aluminum phosphate (Ph) or alum (Al) adjuvant were compared. Local reactions were similar in all four vaccines after the first two immunizations but were significantly increased in incidence and severity following the third immunization with vaccine WcPh. This appeared to be due to the Ph adjuvant rather than the antigen component. Febrile reactions were experienced more often (P = .0009) and with higher temperatures (P = .0001) with the WcPh vaccine following the first immunization. This appeared to be due to the Wc component. Comparing the pooled Wc groups with the pooled E groups revealed a greater febrile response in the Wc group after both the first (P = .0008) and the second (P = .03) immunization. Local reactions appear temporally and etiologically to be distinct from febrile reactions. The pooled Wc antigen group produced a higher geometric mean titer than the pooled E antigen group (P = .05). Serologic responses, with respect to geometric mean titer, were not significantly different among the individual vaccines. This study suggests that the combination of whole cell and aluminum phosphate, which is currently in use in the United States, is probably not the optimal formulation for pertussis vaccine.

Long-Term Protective Immunity of Recipients of the OKA Strain of Live Varicella Vaccine

PEDIATRICS ◽  
1985 ◽  
Vol 75 (4) ◽  
pp. 667-671 ◽  
Author(s):  
Yoshizo Asano ◽  
Takao Nagai ◽  
Takao Miyata ◽  
Takehiko Yazaki ◽  
Shigemitsu Ito ◽  
...  
Keyword(s):  
Varicella Zoster Virus ◽  
Skin Reaction ◽  
Protective Immunity ◽  
Geometric Mean ◽  
Varicella Vaccine ◽  
Geometric Mean Titer ◽  
Positive Skin ◽  
Varicella Zoster ◽  
Mean Diameter

In spite of close contacts with patients who had varicella, 101 of 106 (95%) healthy and sick children (142 of 147 (97%) exposures of these children) who had received the OKA strain of live varicella vaccine 7 to 10 years earlier were protected against the disease completely. Among them, 37 of 38 (97%) vaccine recipients who received immunologic testing had varicella-zoster virus (VZV) antibodies tested by fluorescent antibody to membrane antigen method with a geometric mean titer of 1:9.3, and 37 of the 38 (97%) showed positive skin reaction to varicella-zoster virus antigen with erythema (mean diameter 13.4 mm). These findings were compared with those for 29 children who had contracted typical varicella 7 to 10 years earlier, whose seropositive rate was 100% with a geometric mean titer of 1:10.5, and 97% of whom (28/29) had positive skin reaction with mean diameter of 12.9 mm. These results indicate that the vaccine-induced protective immunity persists for approximately one decade and is almost equal to the long-term immunity following natural infection.

scholarly journals 2712. Safety and Immunogenicity of two Doses of ExPEC4V Vaccine Against Extraintestinal Pathogenic Escherichia coli Disease in Healthy Adult Participants

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S954-S954
Author(s):  
William B Smith ◽  
Darren Abbanat ◽  
Bart Spiessens ◽  
Oscar Go ◽  
Wouter Haazen ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Immune Responses ◽  
Geometric Mean ◽  
Protein A ◽  
Fold Increase ◽  
Vaccine Safety ◽  
Double Blind Study ◽  
Double Blind ◽  
Grade 3 ◽  
O Antigens

Abstract Background The ExPEC4V vaccine contains 4 Escherichia coli O-antigens (O1A, O2, O6A, O25B) conjugated to exotoxin protein A and is being studied for prevention of Invasive Extraintestinal pathogenic E. coli (ExPEC) Disease (IED). This phase-2 double-blind study assessed safety and immunogenicity of ExPEC4V Clinical Trial Material (CTM), manufactured via a redesigned process (optimized O1A strain). Methods Participants (≥18 years) in stable health were randomized (3:1) to receive ExPEC4V dose 4:4:4:8 μg PS/serotype or placebo on Day 1 and second vaccination on Day 181 (6 months after first vaccination). Participants will be followed for safety until end of study at Day 360. Reactogenicity and immunogenicity (by ELISA, opsonophagocytic killing [OPA] assays) were evaluated pre-vaccination, and 15 days after first and second vaccinations (Day 195). Results Of 100 participants randomized (mean age 56, 48% males) and vaccinated (ExPEC4V, n = 75; placebo, n = 25), 97 completed Day 30. Solicited local AEs were higher for ExPEC4V (38.7%) than placebo (20%); most frequent was pain/tenderness (38.7% vs 20%). Solicited systemic AEs were higher in ExPEC4V (49.3%) than placebo (20%); most frequent was fatigue (32% vs. 12%). No serious or grade 3 solicited local AEs were reported. One participant in ExPEC4V experienced a grade 3 solicited systemic fatigue considered vaccine-related by investigator. ExPEC4V demonstrated immune responses against all serotypes at Day 15. Geometric mean titer effective concentration rank by serotypes was O2 > O1A > O6 > O25B (Figures 1 and 2). At Day 15, ≥ 82% of participants in ExPEC4V and none in placebo had ≥2-fold increase from baseline of ELISA titer for all serotypes. In ExPEC4V, ≥47% had ≥2-fold increase from baseline of OPA titer for all serotypes, while 8% in placebo had ≥2-fold increase only for O6A. Good correlation was observed between ELISA and OPA across serotypes (r ≥ 0.76). Conclusion ExPEC4V elicited robust and functional immune responses across all serotypes and was well tolerated with no vaccine safety findings. This study supports the development of future multivalent ExPEC vaccine to prevent IED. Disclosures All authors: No reported disclosures.

scholarly journals Circulating cytomegalovirus (CMV) neutralizing activity in bone marrow transplant recipients: comparison of passive immunity in a randomized study of four intravenous IgG products administered to CMV-seronegative patients

Blood ◽  
1992 ◽  
Vol 80 (10) ◽  
pp. 2656-2660 ◽  
Author(s):  
AH Filipovich ◽  
MH Peltier ◽  
MK Bechtel ◽  
CL Dirksen ◽  
SA Strauss ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplant ◽  
Geometric Mean ◽  
Randomized Study ◽  
Marrow Transplant ◽  
Total Serum ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Double Blind ◽  
Neutralizing Activity

Abstract Forty-two cytomegalovirus (CMV)-seronegative bone marrow transplant (BMT) recipients were randomized in a double-blind fashion to receive one of four commercially available intravenous Ig (IVIgG) products (Gamimmune N, Immune Globulin Intravenous, Gammagard, or Sandoglobulin) at a dose of 500 mg/kg every other week. The four treatment groups were similar in distribution of patient ages, weights, autologous versus allogeneic donor type, and underlying diseases. Every other week administration of IVIgG provided total serum IgG levels within the physiologic range for age. CMV titers by latex agglutination were stable (average geometric mean titer of 18.4 after the second IVIgG dose), with no statistically significant differences among the four product groups. CMV neutralizing activity (CMVNA) and CMV enzyme-linked immunosorbent assay (ELISA) titers were determined on a subset of sera from 27 study patients representing the four product groups. Patient serum samples obtained before IVIgG infusions and 2 weeks after the second IVIgG dose (ie, 3 weeks post-BMT) were assayed for CMVNA and CMV ELISA titers. Geometric mean titers of CMVNA and CMV ELISA varied among the product groups. The highest mean 50% CMVNA was 1:43 for product B, whereas the lowest mean 50% CMVNA was 1:14 for product A; two of the IVIgG product groups showed intermediate 50% mean titers of 1:27 (product C) and 1:26 (product D) for an overall P = .02. CMV ELISA titers (expressed as Paul Ehrlich International units [PEI U]) also showed the highest mean of 2.95 PEI U/mL for product B and the lowest mean of 1.34 PEI U/mL for product A. Intermediate mean values of 2.27 PEI U/mL and 2.03 PEI U/mL were obtained with products C and D, respectively (overall P = .003). The CMV ELISA titers show a minimal correlation (r = .566) to the observed CMVNA titers. We conclude that commercially available IVIgG products provide passive CMVNA, and that the level of circulating CMVNA is affected by the IVIgG product used.

Sign in / Sign up

Export Citation Format

Share Document