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Randomized Controlled Trial
. 2023 Apr 5:36:10938.
doi: 10.3389/ti.2023.10938. eCollection 2023.

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

Yoichiro Natori  1   2 , Eric Martin  1   3 , Adela Mattiazzi  1   4 , Leopoldo Arosemena  1   3 , Mariella Ortigosa-Goggins  1   4 , Sivan Shobana  1   4 , David Roth  1   4 , Warren Lee Kupin  1   4 , George William Burke  1   5 , Gaetano Ciancio  1   5 , Mahmoud Morsi  1   5 , Anita Phancao  1   6 , Mrudula R Munagala  1   6 , Hoda Butrous  1   6 , Suresh Manickavel  1   7 , Neeraj Sinha  1   7 , Katherine Sota  1 , Suresh Pallikkuth  8 , Julia Bini  1   2 , Jacques Simkins  1   2 , Shweta Anjan  1   2 , Rodrigo M Vianna  1   5 , Giselle Guerra  1   4
Affiliations
Randomized Controlled Trial

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

Yoichiro Natori et al. Transpl Int. .

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.

Keywords: COVID-19; booster; randomized controlled trial; solid organ transplant; vaccine.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Study flow chart.
FIGURE 2
FIGURE 2
Quantitative anti-spike protein IgG titer pre and post third dose of either BNT162b2 or JNJ78436735. Each dot represents each participant’s IgG titer at pre or 1 month post third dose of vaccination.
See this image and copyright information in PMC

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