Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants. Riou, C., Bhiman, J. N, Ganga, Y., Sawry, S., Ayres, F., Baguma, R., Balla, S. R, Benede, N., Bernstein, M., Besethi, A. S, Cele, S., Crowther, C., Dhar, M., Geyer, S., Gill, K., Grifoni, A., Hermanus, T., Kaldine, H., Keeton, R. S, Kgagudi, P., Khan, K., Lazarus, E., Le Roux, J., Lustig, G., Madzivhandila, M., Magugu, S. F J, Makhado, Z., Manamela, N. P, Mkhize, Q., Mosala, P., Motlou, T. P, Mutavhatsindi, H., Mzindle, N. B, Nana, A., Nesamari, R., Ngomti, A., Nkayi, A. A, Nkosi, T. P, Omondi, M. A, Panchia, R., Patel, F., Sette, A., Singh, U., van Graan, S., Venter, E. M, Walters, A., Moyo-Gwete, T., Richardson, S. I, Garrett, N., Rees, H., Bekker, L., Gray, G., Burgers, W. A, Sigal, A., Moore, P. L, & Fairlie, L. PLOS Global Public Health, 4(4):e0002703, Public Library of Science (PLoS), apr, 2024.
Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants [link]Paper  doi  abstract   bibtex   
We report the safety and immunogenicity of fractional and full dose Ad26.COV2.S and BNT162b2 in an open label phase 2 trial of participants previously vaccinated with a single dose of Ad26.COV2.S, with 91.4% showing evidence of previous SARS-CoV-2 infection. A total of 286 adults (with or without HIV) were enrolled \textgreater4 months after an Ad26.COV2.S prime and randomized 1:1:1:1 to receive either a full or half-dose booster of Ad26.COV2.S or BNT162b2 vaccine. B cell responses (binding, neutralization and antibody dependent cellular cytotoxicity-ADCC), and spike-specific T-cell responses were evaluated at baseline, 2, 12 and 24 weeks post-boost. Antibody and T-cell immunity targeting the Ad26 vector was also evaluated. No vaccine-associated serious adverse events were recorded. The full- and half-dose BNT162b2 boosted anti-SARS-CoV-2 binding antibody levels (3.9- and 4.5-fold, respectively) and neutralizing antibody levels (4.4- and 10-fold). Binding and neutralizing antibodies following half-dose Ad26.COV2.S were not significantly boosted. Full-dose Ad26.COV2.S did not boost binding antibodies but slightly enhanced neutralizing antibodies (2.1-fold). ADCC was marginally increased only after a full-dose BNT162b2. T-cell responses followed a similar pattern to neutralizing antibodies. Six months post-boost, antibody and T-cell responses had waned to baseline levels. While we detected strong anti-vector immunity, there was no correlation between anti-vector immunity in Ad26.COV2.S recipients and spike-specific neutralizing antibody or T-cell responses post-Ad26.COV2.S boosting. Overall, in the context of hybrid immunity, boosting with heterologous full- or half-dose BNT162b2 mRNA vaccine demonstrated superior immunogenicity 2 weeks post-vaccination compared to homologous Ad26.COV2.S, though rapid waning occurred by 12 weeks post-boost. Trial Registration: The study has been registered to the South African National Clinical Trial Registry (SANCTR): DOH-27-012022-7841 . The approval letter from SANCTR has been provided in the up-loaded documents.
@article{Riou2024,
abstract = {We report the safety and immunogenicity of fractional and full dose Ad26.COV2.S and BNT162b2 in an open label phase 2 trial of participants previously vaccinated with a single dose of Ad26.COV2.S, with 91.4{\%} showing evidence of previous SARS-CoV-2 infection. A total of 286 adults (with or without HIV) were enrolled {\textgreater}4 months after an Ad26.COV2.S prime and randomized 1:1:1:1 to receive either a full or half-dose booster of Ad26.COV2.S or BNT162b2 vaccine. B cell responses (binding, neutralization and antibody dependent cellular cytotoxicity-ADCC), and spike-specific T-cell responses were evaluated at baseline, 2, 12 and 24 weeks post-boost. Antibody and T-cell immunity targeting the Ad26 vector was also evaluated. No vaccine-associated serious adverse events were recorded. The full- and half-dose BNT162b2 boosted anti-SARS-CoV-2 binding antibody levels (3.9- and 4.5-fold, respectively) and neutralizing antibody levels (4.4- and 10-fold). Binding and neutralizing antibodies following half-dose Ad26.COV2.S were not significantly boosted. Full-dose Ad26.COV2.S did not boost binding antibodies but slightly enhanced neutralizing antibodies (2.1-fold). ADCC was marginally increased only after a full-dose BNT162b2. T-cell responses followed a similar pattern to neutralizing antibodies. Six months post-boost, antibody and T-cell responses had waned to baseline levels. While we detected strong anti-vector immunity, there was no correlation between anti-vector immunity in Ad26.COV2.S recipients and spike-specific neutralizing antibody or T-cell responses post-Ad26.COV2.S boosting. Overall, in the context of hybrid immunity, boosting with heterologous full- or half-dose BNT162b2 mRNA vaccine demonstrated superior immunogenicity 2 weeks post-vaccination compared to homologous Ad26.COV2.S, though rapid waning occurred by 12 weeks post-boost. Trial Registration: The study has been registered to the South African National Clinical Trial Registry (SANCTR): DOH-27-012022-7841 . The approval letter from SANCTR has been provided in the up-loaded documents.},
author = {Riou, Catherine and Bhiman, Jinal N and Ganga, Yashica and Sawry, Shobna and Ayres, Frances and Baguma, Richard and Balla, Sashkia R and Benede, Ntombi and Bernstein, Mallory and Besethi, Asiphe S and Cele, Sandile and Crowther, Carol and Dhar, Mrinmayee and Geyer, Sohair and Gill, Katherine and Grifoni, Alba and Hermanus, Tandile and Kaldine, Haajira and Keeton, Roanne S and Kgagudi, Prudence and Khan, Khadija and Lazarus, Erica and {Le Roux}, Jean and Lustig, Gila and Madzivhandila, Mashudu and Magugu, Siyabulela F J and Makhado, Zanele and Manamela, Nelia P and Mkhize, Qiniso and Mosala, Paballo and Motlou, Thopisang P and Mutavhatsindi, Hygon and Mzindle, Nonkululeko B and Nana, Anusha and Nesamari, Rofhiwa and Ngomti, Amkele and Nkayi, Anathi A and Nkosi, Thandeka P and Omondi, Millicent A and Panchia, Ravindre and Patel, Faeezah and Sette, Alessandro and Singh, Upasna and van Graan, Strauss and Venter, Elizabeth M and Walters, Avril and Moyo-Gwete, Thandeka and Richardson, Simone I and Garrett, Nigel and Rees, Helen and Bekker, Linda-Gail and Gray, Glenda and Burgers, Wendy A and Sigal, Alex and Moore, Penny L and Fairlie, Lee},
doi = {10.1371/journal.pgph.0002703},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Riou et al. - 2024 - Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-.pdf:pdf},
journal = {PLOS Global Public Health},
keywords = {Catherine Riou,Jinal N Bhiman,Lee Fairlie,MEDLINE,NCBI,NIH,NLM,National Center for Biotechnology Information,National Institutes of Health,National Library of Medicine,OA,OA{\_}PMC,PMC11008839,PubMed Abstract,doi:10.1371/journal.pgph.0002703,fund{\_}not{\_}ack,original,pmid:38603677},
mendeley-tags = {OA,OA{\_}PMC,fund{\_}not{\_}ack,original},
month = {apr},
number = {4},
pages = {e0002703},
pmid = {38045321},
publisher = {Public Library of Science (PLoS)},
title = {{Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants}},
url = {https://pubmed.ncbi.nlm.nih.gov/38603677/},
volume = {4},
year = {2024}
}

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