SARS-CoV2
Conditions
Interventions
Not Applicable
Sponsors
Moderna Inc
South African Medical Research Council SAMRC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Age 18 and older at time of enrolment • Sisonke participant • Received a priming Ad26.CoV2.S vaccination as part of the Sisonke study • If received a second dose of Ad26.CoV2.S vaccine as part of the Sisonke 2 study, this was administered at least 3 months ago • Participants who are pregnant or report breastfeeding at the time of enrolment may be included. • Willingness and ability to comply with vaccination plan and other study procedures. • Capable and willing to provide informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria • Participants who have received any COVID-19 vaccines other than one or two doses of Ad26.CoV2.S through other means (for example, another mRNA booster dose). • Current participation in any other research studies (other than Sisonke) that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee. • Occurrence of a known COVID-19 outcome within 14 days of enrollment • Participants with a history of heparin-induced thrombocytopenia, or thrombosis and thrombocytopenia syndrome (TTS). • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of mRNA-1273. • Pregnancy which began prior to or within 30 days after the receipt of dose 2 of Ad26.COV2 and ongoing at the time of enrolment in this trial. • Acute infection (e.g. febrile illness) unless resolved before enrolment. • Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant The following participants should only be enrolled after discussion with the PSRT: • Participants who are thought to have suffered a neurological or cardiac AE considered related to the Ad26.CoV2.S vaccine. • Participants reporting a non-infective SAE within the first 28 days following the first or second dose of Ad26.CoV2.S vaccine in the Sisonke 3B trial • History of myocarditis or pericarditis especially in young male • Chronic history of severe clotting disorders • Participants who suffered a thromboembolic AE following the Janssen Covid-19 vaccine. In the event of a clinical contraindication to receiving a heterologous mRNA-1273 booster, the study PSRT, comprising of medical experts in haematology, allergology and neurology supported by sa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives•To compare the effectiveness of Ad26.COV2.S vaccine with a heterologous mRNA-1273 boost on severe COVID-19 (including hospitalizations and deaths) in Sisonke participants, with Sisonke populations not boosted with mRNA-1273. •To compare the effectiveness of Ad26.COV2.S vaccine with a heterologous mRNA-1273 boost on any COVID-19 cases, as compared with Sisonke populations not boosted with mRNA-1273. Secondary objectives•To compare the effectiveness of a single dose of Ad26.COV2.S vaccine with or without a heterologous mRNA-1273 boost on any COVID-19 infection, COVID-19 hospitalizations and deaths in Sisonke participants. •To compare the effectiveness of two doses of Ad26.COV2.S vaccine with or without a heterologous mRNA-1273 boost on any COVID-19 infection, COVID-19 hospitalizations and deaths in Sisonke participants. •To compare the effectiveness of a single dose versus two doses of Ad26.COV2.S vaccine with a heterologous mRNA-1273 boost on any COVID-19 infection, COVID-19 hospitalizations and deaths in Sisonke participants. •To monitor safety among participants, including in pregnant and breastfeeding women, receiving a heterologous mRNA-1273 boost either after a single dose or two doses of Ad26.COV2.S vaccine. •In a subset of participants (approximately N=200), measure the early (Day 29) and late (Month 6) humoral and cellular immune responses to heterologous mRNA-1273 boost either after a single dose or two doses of Ad26.COV2.S vaccine. •To monitor the genetic diversity of breakthrough SARS CoV-2 infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objec To compare the effectiveness of a single dose of Ad26.COV2.S vaccine with against without a heterologous mRNA-1273 boost on any COVID-19 infection, severe COVID, hospitalizations and deaths in Sisonke participants. Rates of COVID-19 infections, hospitalizations and deaths among participants who received a single Ad26.COV2.S dose with or without a mRNA booster To compare the effectiveness of two doses of Ad26.COV2.S vaccine with against without a heterologous mRNA-1273 boost on any COVID-19 infection, severe COVID, hospitalizations and deaths in Sisonke participants. Rates of COVID-19 infections, hospitalizations and deaths among participants who received two doses of Ad26.COV2.S with or without a mRNA booster To compare the effectiveness of a single dose versus two doses of Ad26.COV2.S vaccine with a heterologous mRNA-1273 boost on any COVID-19 infection, severe COVID, hospitalizations and deaths in Sisonke participants. Rates of COVID-19 infections, hospitalizations and deaths among mRNA boosted Sisonke who received one versus two previous doses of Ad26.COV2.S To monitor safety among participants, including among pregnant and breastfeeding women, receiving a heterologous mRNA-1273 boost either after a single dose or two doses of Ad26.COV2.S vaccine. All SAEs and adverse events of special interest and birth outcomes will be collected and reported for 6 months after the mRNA-1273 booster vaccination and for up to 1 year among pregnant women. In a subset of participants (approximately N=200), measure the humoral and cellular immune responses to heterologous mRNA-1273 boost either after a single dose or two doses of Ad26.COV2.S vaccine. Neutralization titres early (Day 29) and late (Month 6) post-boost versus baseline using pseudovirus and/or live virus neutralization assays. T cell response magnitudes post-boost versus baseline using intracellular cytokine staining. To monitor the genetic diversity of breakthrough SARS CoV-2 infections Genetic | — |
Countries
South Africa
Contacts
Public ContactKentse Khuto
Senior Site Liaison Manager
Outcome results
None listed