The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in adults.
This is a phase 1, multisite clinical trial to evaluate the safety and immunogenicity of 3 dose levels of VXCO-100 in adults. Participants will be vaccinated with a selected dose of VXCO-100 or a COVID-19 mRNA vaccine. Participants will receive a dose of VXCO-100 on Day 1. A matched optional boost on month 6 will be offered to a subset of participants in Groups 1-3. Participants receiving a COVID-19 mRNA vaccine will be vaccinated on Day 1 and Day 21. Safety will be evaluated before proceeding to a higher dose level.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
Sterile suspension for injection
Sterile suspension for injection
Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
HIV and other Infectious Diseases Research Unit (HIDRU), South African Medical Research Council
Botha’s Hill, KwaZulu-Natal, South Africa
Number and percentage of participants with solicited local adverse events
Time frame: For 7 days after each product administration
Number and percentage of participants with solicited systemic adverse events
Time frame: For 7 days after each product administration
Number and percentage of participants with unsolicited and safety laboratory-based adverse events
Time frame: For 28 days after each product administration
Numbers and percentages of participants with serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs)
Time frame: For 364 days after each product administration
Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain
Time frame: At baseline and 21 days after each product administration
Response rate measured by GMT of Nab against selected variants of concern
Time frame: At baseline and 21 days after each product administration
Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining
Time frame: At baseline and 7 days after each product administration
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