This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
Janssen or Pfizer vaccines (control arm)
Wits Vida
Johannesburg, South Africa
Phase 1 Safety - Incidence of MAAEs Through 1 Week
Incidence of medically-attended adverse events (MAAEs)
Time frame: through 1 week post final vaccine administration
Phase 1 Safety - Incidence of MAAEs Through 30 Days
Incidence of MAAEs
Time frame: through 30 days post final vaccine administration
Phase 1 Safety - Incidence of MAAEs Through 6 Months
Incidence of MAAEs
Time frame: through 6 months post final vaccine administration
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
Incidence and severity of solicited local reactogenicity AEs
Time frame: through 1 week after each vaccine dose
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs
Time frame: through 1 week after each vaccine dose
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
Incidence and severity of unsolicited AEs
Time frame: through 1 week post final vaccine administration
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
Incidence and severity of unsolicited AEs
Time frame: through 30 days post final vaccine administration
Phase 1 Safety - Incidence of SAEs Through 1 Week
Incidence of serious adverse events (SAEs)
Time frame: through 1 week post final vaccine administration
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Phase 1 Safety - Incidence of SAEs Through 30 Days
Incidence of SAEs
Time frame: through 30 days post final vaccine administration
Phase 1 Safety - Incidence of SAEs Through 6 Months
Incidence of SAEs
Time frame: through 6 months post final vaccine administration