A Phase 1 interventional study of LYB014 low dose and LYB014 high dose in Malaria Vaccine, sponsored by Guangzhou Patronus Biotech Co., Ltd.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Guangzhou Patronus Biotech Co., Ltd. · Phase 1, Interventional, and Prevention
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 progresses in a sequential manner, with Group 1 and Group 3 being enrolled and vaccinated first. Sentinels are employed for each group during the first dose vaccination. Each group includes 3 sentinel participants who are dosed first. When the sentinel participants complete the laboratory tests 3 days after first vaccination, the principal investigator (PI) conducts the preliminary safety assessment including the laboratory tests results and confirm safety (none of the sentinel participants experiences a vaccine related death or life-threatening SAE or a vaccine related AE assessed as > 48h of grade 3 or higher), then remainder of cohort (ROC) in each group can be vaccinated.
The Safety Review Committee (SRC) reviews the safety data after all participants in Group 1 and Group 3 complete 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 reviews the safety data after all participants in Group 2, Group 4 and Group 5 complete 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 reviews the safety data after all participants in Group 6 complete 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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 72 is below the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Guangzhou Patronus Biotech Co., Ltd. is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Healthy males or females aged 18-50 years (inclusive) at the time of screening.
2) Written obtained from the participant before any assessment is performed.
3) Participants who the investigator believes that they can and will comply with the requirements of the protocol. (e.g., complete the diary cards, and complete follow-up visits).
4) Participants must have a (BMI) between ≥18.0 and ≤35.0 kg/m2 at screening.
5) Female participants who are not pregnant or lactating. Female participants with and their partners should use highly effective, medically accepted double-barrier , or persistent lifestyle abstinence and will not have pregnancy and fertility plan and refrain from donating ovum from at least 28 days prior to study vaccination/Day 1 until study completion.
Note: There is no contraception requirement for female participants with non-childbearing potential (WNCBP) and WNCBP participants' male partners must use a condom from study vaccination/Day 1 until study completion. Female participants who are in same-sex relationships are not required to use contraception.
6) Males participating in this study who are involved in heterosexual sexual activity with a female partner of childbearing potential must agree to use highly effective, medically accepted double-barrier contraception (as described above), or persistent lifestyle abstinence and refrain from donating sperm from at least 28 days prior to study vaccination until study completion.
Exclusion Criteria:
1) Tympanic temperature > 37.5°C at screening or prior to first vaccination. 2) Received a within 28 days before first vaccination or received other vaccines within 14 days before first vaccination.
3) Participation in another research study involving receipt of an product in the 30 days preceding enrolment, or planned use during the study period.
4) Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
5) Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
6) Any confirmed or suspected or immunodeficient state, including infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical are allowed).
7) Any acute disease or acute attack of chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 24 h prior to the first vaccination.
8) Allergies to any component of the investigational vaccine. 9) Any history of anaphylaxis in relation to vaccination. 10) History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ, the above two types of carcinomas must be fully resolved for at least 3 months before screening).
11) History of serious psychiatric or neurological condition likely to affect participation in the study (except history of childhood or febrile seizures; history of anxiety, depression, or attention-deficit/hyperactivity disorder (ADHD) that remains stable, with no required medication for the conditions for at least 6 months prior to screening, and no worsening requiring intervention).
12) Congenital or acquired disease. 13) Any other serious chronic illness requiring hospital specialist supervision.
14) A positive urine drug test (except positive cotinine results due to casual and social smoking) or alcohol breath test at screening or Day 1.
15) Weekly cigarette consumption exceeding 5 cigarettes, and unwilling to completely abstain from smoking during their stay at the clinical site.
16) Positive test for virus (HCV), surface antigen (HbsAg), human immunodeficiency virus (HIV) at screening.
17) History of clinical malaria (any species). 18) Travel to a malaria endemic region during the study period or within 4 weeks prior to first vaccination.
19) Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
20) Have donated blood or plasma within 7 days prior to screening. 21) Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data.
22) Other conditions that may impact the participant's safety or influence the assessment of vaccine response, as determined by the investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults (18-50 years old) will receive three injections of low dose LYB014 at 28-day intervals.
Biological: LYB014 low dose
Adults (18-50 years old) will receive three injections of high dose LYB014 at 28-day intervals.
Biological: LYB014 high dose
Adults (18-50 years old) will receive three injections of low dose LYB017 at 28-day intervals.
Biological: LYB017 low dose
Adults (18-50 years old) will receive three injections of high dose LYB017 at 28-day intervals.
Biological: LYB017 high dose
Adults (18-50 years old) will receive three injections of low dose LYB027 at 28-day intervals.
Biological: LYB027 low dose
Adults (18-50 years old) will receive three injections of high dose LYB027 at 28-day intervals.
Biological: LYB027 high dose
Adults (18-50 years old) will receive three injections of A02B adjuvant at 28-day intervals.
Biological: Control A02B adjuvant
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.
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.
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
The incidence, severity and causality of any solicited local and systemic 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
Laboratory abnormalities
The occurrence, severity and causality of clinically significant laboratory abnormalities
Time frame: 3 days and 28 days post each vaccination, and at 84 days after 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 Plasmodium falciparum- and Plasmodium vivax-specific antibodies.
Time frame: At baseline and 28 days post each vaccination and 84 days, 168 days and 336 days post the third vaccination.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Guangzhou Patronus Biotech Co., Ltd.