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. 2025 Sep 16;12(10):ofaf578.
doi: 10.1093/ofid/ofaf578. eCollection 2025 Oct.

Vaccine Induced Seroreactivity Following Administration of ALVAC-HIV/AIDSVAX®B/E Identified by Common Anti-HIV Test Kits and Algorithms in Thailand

Siriwat Akapirat  1 , Elisavet Serti  2   3 , Punnee Pitisutthithum  4 , Sorachai Nitayaphan  5 , Suwat Chariyalertsak  6   7 , Chirapa Eamsila  5 , Pornchanok Panjapornsuk  1 , Anocha Kleebmontha  5 , Somsak Chantakulkij  1 , Bhubate Tongchanakarn  1 , Hathairat Savadsuk  1 , Jittima Dhitavat  4 , Sanjay Gurunathan  8 , Faruk Sinangil  9 , Trevor A Crowell  2   3 , Nelson L Michael  10 , Merlin L Robb  3 , Sandhya Vasan  2   3 , Robert J O'Connell  1   11 ; RV306 Study Group
Collaborators, Affiliations

Vaccine Induced Seroreactivity Following Administration of ALVAC-HIV/AIDSVAX®B/E Identified by Common Anti-HIV Test Kits and Algorithms in Thailand

Siriwat Akapirat et al. Open Forum Infect Dis. .

Abstract

Vaccine-induced seroreactivity (VISR) was evaluated in RV306 and was shown to vary markedly (0-32.5%) among 6 HIV diagnostic tests and 84 algorithms. Our data show that selecting the SD Bioline HIV-1/2 assay and algorithms which exclude the ImmunoComb®II Bispot and Alere™ Determine HIV-1/2 assays would almost eliminate VISR in RV306.

Keywords: HIV-1; VISP; VISR; vaccine-induced seroreactivity.

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Conflict of interest statement

Potential conflicts of interest. F. S. is an employee of Global Solutions for Infectious Diseases. J. T. and S. P. are employees of Sanofi Pasteur. All other authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
(A) Vaccine induced seroreactivity (VISR) rates in 255 RV306 samples using 3 enzyme immunoassays (EIAs; ARCHITECT HIV Ag/Ab Combo, Genscreen ULTRA HIV Ag-Ab, and Elecsys HIV Combi PT) and 3 rapid diagnostic tests (RDTs; Determine HIV-1/2, SD Bioline HIV-1/2 3.0, and ImmunoComb® II HIV-1/2 Bispot) at wks 0, 26 (2 wks after completion of RV144 vaccine series), 50, 62, 74 (2 wks after boosting, depending on the group), and at wk96. (B) VISR and (C) VISP using 16 Thai-guidelines specified RDT/EIA algorithms (black) and 68 simulated algorithms (gray) at any time point (wks 0, 26, 50, 62, 74, and 96). Antigen reactive specimens by the first anti-HIV test were retested with the second test to confirm reactivity before further tested by the third test. Any specimens with positive or reactive results on any of 3 tests were identified as VISR specimens. Any specimens with positive or reactive results on all 3 kits were identified as algorithm seropositive (VISP). The differences in % HIV reactivity between each assay and/or algorithm were assessed using a nonparametric Fisher's Exact test and P-values ≤.05 were defined as significant. **** Indicates P-value < .0001.
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