AUTHOR=Natori Yoichiro , Martin Eric , Mattiazzi Adela , Arosemena Leopoldo , Ortigosa-Goggins Mariella , Shobana Sivan , Roth David , Kupin Warren Lee , Burke George William , Ciancio Gaetano , Morsi Mahmoud , Phancao Anita , Munagala Mrudula R. , Butrous Hoda , Manickavel Suresh , Sinha Neeraj , Sota Katherine , Pallikkuth Suresh , Bini Julia , Simkins Jacques , Anjan Shweta , Vianna Rodrigo M. , Guerra Giselle
TITLE=A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients
JOURNAL=Transplant International
VOLUME=36
YEAR=2023
URL=https://www.frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2023.10938
DOI=10.3389/ti.2023.10938
ISSN=1432-2277
ABSTRACT=Solid Organ Transplant (SOT) recipients are at significant higher risk for COVID-19 and due to immunosuppressive medication, the immunogenicity after vaccination is suboptimal. In the previous studies, booster method showed significant benefit in this population. In the current study, we compared using a mix-and-match method vs. same vaccine as a third dose in SOT recipients. This was a patient-blinded, single center, randomized controlled trial comparing BNT162b2 vs. JNJ-78436735 vaccine as the third dose after two doses of BNT162b2 vaccine. We included adult SOT recipients with functional graft who had received two doses of BNT162b2 vaccine. Participants were randomly assigned to receive either BNT162b2 or JNJ-78436735 in one-to-one ratio. Primary outcome was SARS-CoV-2 IgG positivity at 1 month after the third dose. Sixty SOT recipients, including 36 kidney, 12 liver, 2 lung, 3 heart, and 5 combined transplants, were enrolled, and 57 recipients were analyzed per protocol. There were no statistically significant differences between the two vaccine protocols for IgG positivity (83.3% vs. 85.2% for BNT162b2 and JNJ-78436735, respectively, p = 0.85, Odds Ratio 0.95, 95% Confidence Interval 0.23–4.00). Comparison of the geometric mean titer demonstrated a higher trend with BNT162b2 (p = 0.09). In this pilot randomized controlled trial comparing mix and match method vs. uniform vaccination in SOT recipients, both vaccines were safely used. Since this was a small sample sized study, there was no statistically significant difference in immunogenicity; though, the mix and match method showed relatively lower geometric mean titer, as compared to uniform vaccine. Further studies need to be conducted to determine duration of this immunogenicity.
Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05047640?term=20210641&draw=2&rank=1, identifier 20210641.