Study Protocol
Safety, tolerability, and preliminary immunogenicity of a recombinant Staphylococcus aureus vaccine (RSAV) in healthy adults between 18 and 65 years in China: study protocol for a randomized, double-blind, placebo-controlled, phase 1 trial
Abstract
Background: Staphylococcus aureus (S. aureus), a gram positive bacteria, is one of a major cause of hospital-associated and community-associated infections worldwide. This trial aims to evaluate the safety and tolerability of a recombinant Staphylococcus aureus vaccine (RSAV), and to explore its preliminary immunogenicity.
Methods: This is a single center, double-blind, placebo-controlled, phase 1 clinical trial of RSAV. Healthy participants aged between 18 and 65 years will be recruited. A total of 144 participants will be included and then randomly allocated to the low-dose group, middle-dose group, high-dose group, or placebo group in a ratio of 1:1:1:1, to received three-dose vaccination at day 0, 3, and 7. A nested randomization within each treatment group is performed for the fourth dose vaccination: participants will be randomly assigned in a ratio of 2:1 to receive a vaccine or placebo at day 14. Participant will be followed for adverse reactions for 42 days and donate the blood samples at 11 scheduled time points during the whole 6-month study period. The primary endpoint is the occurrence of solicited adverse reactions within 21 days after first injection.
Discussion: This is the first study to evaluate the safety and immunogenicity profile of the RSAV in healthy adults. The results would allow us to gain more insight in this novel S. aureus vaccine candidate and enable larger studies in the future.
Methods: This is a single center, double-blind, placebo-controlled, phase 1 clinical trial of RSAV. Healthy participants aged between 18 and 65 years will be recruited. A total of 144 participants will be included and then randomly allocated to the low-dose group, middle-dose group, high-dose group, or placebo group in a ratio of 1:1:1:1, to received three-dose vaccination at day 0, 3, and 7. A nested randomization within each treatment group is performed for the fourth dose vaccination: participants will be randomly assigned in a ratio of 2:1 to receive a vaccine or placebo at day 14. Participant will be followed for adverse reactions for 42 days and donate the blood samples at 11 scheduled time points during the whole 6-month study period. The primary endpoint is the occurrence of solicited adverse reactions within 21 days after first injection.
Discussion: This is the first study to evaluate the safety and immunogenicity profile of the RSAV in healthy adults. The results would allow us to gain more insight in this novel S. aureus vaccine candidate and enable larger studies in the future.
