Assessing the Safety, Immunogenicity and Ex-vivo Efficacy of Two Candidate Malaria Transmission Blocking Vaccines, Pfs25-IMX313 and Pfs45/48 Administered Alone and in Combination, in Matrix-M Adjuvant

Launched by UNIVERSITY OF OXFORD · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two potential vaccines designed to help prevent the transmission of malaria, specifically the Plasmodium falciparum type, which is common in many parts of Africa. The study aims to assess how safe these vaccines are, how well they work in generating an immune response (which helps the body fight infections), and their effectiveness when tested outside the body (ex-vivo efficacy). The trial will involve healthy individuals aged 5 to 45 years from Burkina Faso and will test these vaccines both individually and together.

To participate, volunteers must be in good health and meet specific criteria, such as not having received a malaria vaccine before and not being part of any other clinical trials that could interfere with results. Participants will need to give informed consent, and if they are under 18, their parents or guardians must also agree. Throughout the study, participants will be monitored for any side effects and will be expected to avoid blood donation and pregnancy during the trial. This research is important because it could lead to new ways to combat malaria, a disease that affects millions of people worldwide.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All volunteers must satisfy all the following criteria to be eligible for the study
• • Healthy adults, adolescents and children based on medical history, physical examination and baseline blood tests
• • Age: 5-45 years of age at the time of enrollment (i.e. up to the day before their 46th birthday).
• • Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the participant to join the trial (if under the age of 18). For participants aged 18 and above, signed informed consent/thumb-printed of the participant.
• • Signed informed assent/thumb-printed and witnessed assent obtained from participants (for age group 12-17 years old only).
• • The investigator believes that the participant and their parents/guardians (if participant aged under 18) can and will comply with the requirements of the protocol.
• • The participant is a permanent resident of the study area and likely to remain a resident for the duration of the trial.
• • Agreement to refrain from blood donation for the duration of the study
• • Female participants of childbearing potential (WOCBP) must agree to avoid pregnancy during the duration of the study and practice continuous effective contraception if sexually active.
• Acceptable forms of contraception for female volunteers of childbearing potential include:
• • Established use of oral, injected or implanted hormonal methods of contraception.
• • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• • Total abdominal hysterectomy.
• • Sex abstinence/not sexually active
• • Exclusion Criteria
• • The volunteer has previously received a malaria vaccine.
• • The volunteer is enrolled in another malaria intervention trial.
• • The volunteer is currently participating in another clinical trial if likely to affect data interpretation of either trial.
• • The volunteer has a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
• • The volunteer has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
• • The volunteer has anaemia associated with clinical signs of decompensation, or a haemoglobin of ≤ 7.4 g/dL
• • The volunteer has been administered immunoglobulins and/or any blood products including blood transfusion within the three months preceding the planned administration of the vaccine candidate.
• • Receipt of a vaccine 30 days prior to study vaccine administration or planning to receive one within 30 days after administration of any of the doses of the study vaccine.
• • The volunteer has malnutrition requiring hospital admission.
• • The volunteer has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests
• • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
• • Pregnancy, lactation or intention to become pregnant during the study.
• • Hepatitis B surface antigen (HBsAg) detected in serum.
• • Antibodies to HCV (HCV-Ab) detected in serum.
• • Any other significant disease, disorder, or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
• The following criteria should be checked during the study, prior to each vaccination:
• • • Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.