2. Academic Validation
  3. Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial

Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial

  • Obstet Gynecol Sci. 2020 May;63(3):315-322. doi: 10.5468/ogs.2020.63.3.315.
Rahul Vishwanath Mayekar 1,  Gopalkrishna Vinayak Paradkar 2,  Archana Anilkumar Bhosale 1,  Rekha Sachan 3,  Sumalatha Beeram 4,  Ashok Ramachandra Anand 5,  Shuchita Ramesh Mundle 6,  Yamini Trivedi 7,  Rashmi Md 8,  Kiran Pandharinath Patole 9,  Pradip Wamanrao Sambarey 10,  Gautam Vinod Daftary 11,  James John 11,  Ganesh Harishchandra Divekar 11
Affiliations

Affiliations

  • 1 Department of Obstetrics and Gynaecology, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Mumbai, India.
  • 2 Department of Obstetrics and Gynaecology, Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital, Thane, India.
  • 3 Department of Obstetrics and Gynaecology, King George's Medical University, Lucknow, India.
  • 4 Department of Obstetrics and Gynaecology, Gandhi Medical College and Hospital, Secunderabad, India.
  • 5 Department of Obstetrics and Gynaecology, Grant Medical College and Sir J.J. Group of Hospitals, Mumbai, India.
  • 6 Department of Obstetrics and Gynaecology, Government Medical College and Hospital, Nagpur, India.
  • 7 Department of Obstetrics and Gynaecology, AMC MET Medical College and Sheth LG General Hospital, Ahmedabad, India.
  • 8 Department of Obstetrics and Gynaecology, Apollo BGS Hospital, Mysore, India.
  • 9 Department of Obstetrics and Gynaecology, Dr. Vasantrao Pawar Medical College and Research Centre, Nashik, India.
  • 10 Department of Obstetrics and Gynaecology, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
  • 11 Clinical Research and Pharmacovigilance, Bharat Serums and Vaccines Limited, Navi Mumbai, India.
PMID: 32489976 DOI: 10.5468/ogs.2020.63.3.315
Abstract

Objective: To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D.

Methods: This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of Antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test.

Results: A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed Antibodies against R-anti-D.

Conclusion: The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.

Keywords

Newborn hemolytic disease; Recombinant proteins; Rh isoimmunization; Rho(D) immune globulin.

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