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Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants.
Riou, Catherine; Bhiman, Jinal N; Ganga, Yashica; Sawry, Shobna; Ayres, Frances; Baguma, Richard; Balla, Sashkia R; Benede, Ntombi; Bernstein, Mallory; Besethi, Asiphe S; Cele, Sandile; Crowther, Carol; Dhar, Mrinmayee; Geyer, Sohair; Gill, Katherine; Grifoni, Alba; Hermanus, Tandile; Kaldine, Haajira; Keeton, Roanne S; Kgagudi, Prudence; Khan, Khadija; Lazarus, Erica; Roux, Jean Le; Lustig, Gila; Madzivhandila, Mashudu; Magugu, Siyabulela Fj; Makhado, Zanele; Manamela, Nelia P; Mkhize, Qiniso; Mosala, Paballo; Motlou, Thopisang P; Mutavhatsindi, Hygon; Mzindle, Nonkululeko B; Nana, Anusha; Nesamari, Rofhiwa; Ngomti, Amkele; Nkayi, Anathi A; Nkosi, Thandeka P; Omondi, Millicent A; Panchia, Ravindre; Patel, Faeezah; Sette, Alessandro; Singh, Upasna; van Graan, Strauss; Venter, Elizabeth M; Walters, Avril; Moyo-Gwete, Thandeka; Richardson, Simone I; Garrett, Nigel; Rees, Helen.
Affiliation
  • Riou C; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Bhiman JN; Wellcome Centre for Infectious Diseases Research in Africa, University of Cape Town, Observatory, South Africa.
  • Ganga Y; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Sawry S; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Ayres F; Africa Health Research Institute, Durban, South Africa.
  • Baguma R; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Balla SR; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Benede N; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Bernstein M; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Besethi AS; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Cele S; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Crowther C; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Dhar M; Africa Health Research Institute, Durban, South Africa.
  • Geyer S; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Gill K; Africa Health Research Institute, Durban, South Africa.
  • Grifoni A; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Hermanus T; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Kaldine H; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Keeton RS; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Kgagudi P; The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
  • Khan K; Center for Vaccine Innovation, La Jolla Institute for Immunology, La Jolla, California, USA.
  • Lazarus E; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Roux JL; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Lustig G; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Madzivhandila M; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Magugu SF; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Makhado Z; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Manamela NP; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Mkhize Q; Africa Health Research Institute, Durban, South Africa.
  • Mosala P; School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.
  • Motlou TP; Perinatal HIV Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
  • Mutavhatsindi H; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Mzindle NB; Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
  • Nana A; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Nesamari R; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Ngomti A; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Nkayi AA; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Nkosi TP; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Omondi MA; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Panchia R; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Patel F; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Sette A; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Singh U; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • van Graan S; Center for HIV and STIs, National Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
  • Venter EM; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Walters A; SA MRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
  • Moyo-Gwete T; Perinatal HIV Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
  • Richardson SI; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Garrett N; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
  • Rees H; Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Observatory, South Africa.
medRxiv ; 2023 Nov 20.
Article in En | MEDLINE | ID: mdl-38045321
ABSTRACT

Background:

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.

Methods:

A total of 286 adults (with or without HIV) were enrolled >4 months after an Ad26.COV2.S prime and randomized 1111 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.

Results:

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.

Conclusion:

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 South African National Clinical Trial Registry (SANCR) DOH-27-012022-7841.

Funding:

South African Medical Research Council (SAMRC) and South African Department of Health (SA DoH).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: MedRxiv Year: 2023 Document type: Article Affiliation country: South Africa
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: MedRxiv Year: 2023 Document type: Article Affiliation country: South Africa