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.
1) Healthy males or females aged 18-50 years (inclusive) at the time of screening.
A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Highly effective double-barrier contraception is defined as use of a condom AND one of the following from at least 28 days prior to study vaccination/Day 1 until study completion: birth control pills (The Pill), depot or injectable birth control, intrauterine device (IUD), NuvaRing®, implantable contraception (e.g., Implanon).
Female participants who have had bilateral tubal ligation and are willing to use a condom when sexually active with the opposite sex.
1) Tympanic temperature > 37.5°C at screening or prior to first vaccination. 2) Received a live attenuated vaccine within 28 days before first vaccination or received other vaccines within 14 days before first vaccination.
Parallel
LYB014 low dose
Biological/VaccineDosage 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.
LYB014 high dose
Biological/VaccineDosage 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.
LYB017 low dose
Biological/VaccineDosage 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.
LYB017 high dose
Biological/VaccineDosage 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.
LYB027 low dose
Biological/VaccineDosage 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.
LYB027 high dose
Biological/VaccineDosage 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.
Control A02B adjuvant
Biological/VaccineDosage 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.
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Treatment groupsSee each treatment group below.
Immediate adverse events (AEs) within 30 minutes after each vaccination
The incidence, severity and causality of any AEs within 30 minutes 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
Unsolicited AEs
The incidence, severity and causality of any unsolicited AEs 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
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 Plasmodium falciparum- and Plasmodium vivax-specific antibodies.
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This trial is not recruiting at the moment. You can still explore other options:
