NCT05370040

THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines

THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	AAHI-SC2 Vaccine	AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
BIOLOGICAL	AAHI-SC3 Vaccine	AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
BIOLOGICAL	EUA or approved vaccine	Janssen or Pfizer vaccines (control arm)

Timeline

• Start date: 2022-05-05
• Primary completion: 2024-03-11
• Completion: 2024-03-11
• First posted: 2022-05-11
• Last updated: 2025-03-11
• Results posted: 2024-05-01

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study