Official Title
A Phase Ib Open Label Clinical Trial of 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 in Healthy Adults, Adolescents and Young Children in Burkina Faso
Brief Summary

Assessing the safety, immunogenicity and ex-vivo efficacy of two transmission blockingvaccines (Pfs25-IMX313 in Matrix M and Pfs48/45 in Matrix M alone and co-administered) inBurkina Faso, in 18-45 years, 12-17 years and 05-11 year olds.

Detailed Description

Not Provided

Not yet recruiting
Plasmodium Falciparum Malaria

Biological: Pfs25-IMX313, Pfs48/45

Two soluble protein vaccines.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 5 Years ~ Maximum: 45 Years
Locations

Not Provided

Contacts

Chris L williams, PhD
07979513371
chris.williams@ndm.ox.ac.uk

Sumi Biswas, PhD
SUMI.BISWAS@NDM.OX.AC.UK

Paola Cicconi, PhD, Principal Investigator
University of Oxford

European and Developing Countries Clinical Trials Partnership (EDCTP)
NCT Number
MeSH Terms
Malaria
Malaria, Falciparum