Evaluation of IVIG for Prevention of Infections Occurring On-study and Treatment of Infection of Solid Organ Recipients With Secondary Antibody Deficiency: A Phase 2 Randomized Clinical Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background. There is a paucity of data to guide the management of posttransplant secondary antibody deficiency (SAD). We aimed to evaluate the role of IVIG in solid organ recipients with SAD. Methods. A phase 2, randomized, multicenter, open-label study of solid organ recipients with severe infection and SAD defined as serum IgG <600 mg/dL. The study evaluated the efficacy of adding a fixed protocol of IVIG early after detection of SAD to standard of care (SOC) for the prevention of infection occurring on-study and the treatment of infections, versus SOC. We also assessed reconstitution of humoral immunity in a substudy. Forty‐four transplant recipients were randomized in 6 transplant centers in Spain. The IVIG protocol comprised 2 doses of 15 g (interval 7–15 d) followed by 3 doses of 20 g (interval 15–30 d). The primary endpoint was infection occurring on-study defined as a new severe infection after randomization. Results. Forty-two patients were included in the intention-to-treat analysis (IVIG arm, n = 21 versus non-IVIG arm, n = 21). The rate of infection occurring on-study was lower in patients randomized to receive IVIG versus SOC (23.8% versus 66.7%, Fisher exact test, P = 0.012). The median number of infections occurring on-study was lower in the IVIG group. The median total number of new admissions considered to be related to an infection occurring on-study was significantly lower in IVIG-treated patients. A significant increase in specific anti-cytomegalovirus IgG, anti–varicella zoster IgG, anti- Clostridium difficile toxins A and B IgG, and anti-tetanus toxoid IgG and IgG1 was demonstrated in the IVIG arm. Conclusions. In solid organ recipients with severe infection and SAD, IVIG may reduce infection occurring on-study occurrence versus SOC.
Source: Transplantation Direct
Authors: Elizabeth Sarmiento, Judith Montanchez, Ikram Ezzahouri, Jose Cifrian, Carlos Ortiz-Bautista, Rosalia Laporta, Carles Bravo, Magdalena Salcedo, Maria Luisa Rodriguez-Ferrero, Jose Gonzalez-Costello, Javier Segovia, Alicia de Pablos, Victor Mora, Piedad Ussetti, Sonia Lopez, Nuria Sabe, Manuel Gomez-Bueno, Iago Sousa, Paula Navas, Pablo Diez-Villanueva, Myriam Aguilar, Ainhoa Fernandez-Yunquera, Fernando Anaya, Patricia Muñoz, Maricela Valerio, Ana Mur, Alba Alarcon, Kristofer Limay, Marcos Lopez-Hoyos, Francisco Lopez, Ana Vionnet, Manuel Serrano, Javier Carbone
Institutions: Hospital General Universitario Gregorio Marañón, Marqués de Valdecilla University Hospital, Universidad Complutense de Madrid, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario Puerta de Hierro Majadahonda, Universidad Autónoma de Madrid, Vall d'Hebron Hospital Universitari, Bellvitge University Hospital, Hospital Universitario 12 De Octubre
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $2,200
OpenAlex ID: W7133530896