This is a clinical trial in which healthy volunteers will receive one of three investigational malaria vaccines (LYB014, LYB017, and LYB027) administered in combination with the A02B adjuvant, or the A02B adjuvant alone as the control.
A phase I, randomized, double-blinded, controlled, dose escalation study will be conducted to observe the safety and immunogenicity of LYB014, LYB017 and LYB027 in healthy adults aged 18-50 years old. This study includes six groups: Group 1, receiving a low dose of LYB014; Group 2, receiving a high dose of LYB014; Group 3, receiving a low dose of LYB017; Group 4, receiving a high dose of LYB017; Group 5, receiving a low dose of LYB027; and Group 6, receiving a high dose of LYB027. The adjuvant alone will serve as the control for all groups. The study progressed in a sequential manner, with Group 1 and Group 3 being enrolled and vaccinated first. Sentinels were employed for each group during the first dose vaccination. Each group included 3 sentinel participants who were dosed first. When the sentinel participants completed the laboratory tests 3 days after first vaccination, the principal investigator (PI) conducted the preliminary safety assessment including the laboratory tests results and confirmed safety, then remainder of cohort (ROC) in each group could be vaccinated.The Safety Review Committee (SRC) reviewed the safety data after all participants in Group 1 and Group 3 completed the 7 days visit after the first vaccination to allow the second vaccine dose in the Group 1 and Group 3, and the first vaccination in Group 2, Group 4 and Group 5. The SRC reviewed the safety data after all participants in Group 2, Group 4 and Group 5 completed the 7 days visit after the first vaccination to allow the second vaccine dose in Group 2, Group 4 and Group 5, and the first vaccination in Group 6. The SRC reviewed the safety data after all participants in Group 6 completed the 7 days visit after the first vaccination to allow the second vaccine dose in Group 6. SRC will review the 7-day safety data after second vaccination for participants in Group 1 and Group 3, and confirm the safety (meet no criteria for suspension/termination of the study) to allow third vaccination for Group 1 and Group 3. The same holds true for Group 2, Group 4 and Group 5, and Group 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
72
Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.
Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.
Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.
Nucleus Network Pty Ltd.
Melbourne, Australia
Immediate adverse events (AEs) within 30 minutes after each vaccination
The incidence, severity and causality of any AEs within 30 minutes after each vaccination
Time frame: 30 mins after each vaccination
Solicited local and systemic AEs and unsolicited AEs
The incidence, severity and causality of any solicited local and systemic AEs and unsolicited AEs within 7 days after each vaccination
Time frame: Within 7 days after each vaccination
Unsolicited AEs
The incidence, severity and causality of any unsolicited AEs within 28 days after each vaccination.
Time frame: Within 28 days after each vaccination
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
The incidence and causality of any SAEs and AESIs
Time frame: From the first vaccination through 336 days post the third vaccination
The humoral immunogenicity (antibody response)
Comparison of immunogenicity (antibody responses) of LYB014, LYB017, and LYB027 and the longevity of responses. ELISA to quantify antibodies to the vaccine components Pf CSP, Pf RH5, Pf s230, Pv CSP (VK210 /VK247 hybrid), Pv DBPII and Pv s230.
Time frame: At baseline and 28 days post each vaccination and 84 days, 168 days and 336 days post the third vaccination.
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Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.
Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.
Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.
Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.