Official Title
Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
Brief Summary

This is a single blind randomised controlled trial. This study aims to assess whether ahalf-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in childand adults. The results will help optimize vaccine usage and improve malaria preventionstrategies.All participants will receive the same number of injections and will be randomly assignedto receive one of the followings: 1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125). or 2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.If participant receive the half dose, it will come from one of two types of vaccine:2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 10 dose vials with 2PEPreservative (n=125)Clinical procedure for participants: - Standardized symptom questionnaire - Physical examination: - Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. - Spleen and liver size will be recorded if palpable. - Pregnancy test (for female of child bearing potential) - Venous blood collection (Pre-vaccination) 3mL - Vaccination

Detailed Description

Not Provided

Not yet recruiting
Plasmodium Falciparum Malaria
Malaria
Vaccine Reaction

Biological: 10μg R21/50μg Matrix-M

Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M
(n=125)

Biological: 5μg R21/50μg Matrix-M with adaptor preservative free

Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg
Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)

Biological: 5μg R21/50μg Matrix-M with 2PE preservative

Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg
Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)

Eligibility Criteria

Inclusion Criteria:

- Residence in a study village for the study period, i.e. 12 months.

- Age 14 years to 60 years.

- Written informed consent/assent provided by participants (or a parent/guardian in
case the participant is under 18 years old).

Exclusion Criteria:

- Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.

- Acute illness requiring intervention.

- A history of an adverse reaction to study vaccine.

- Prior receipt of any other malaria vaccine.

- Enrolment in another intervention trial in the last month.

- Planned enrolment in another intervention trial in the coming 12 months.

- Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc.
in the past month and/or planned for the coming 12 months.

Eligibility Gender
All
Eligibility Age
Minimum: 14 Years ~ Maximum: 60 Years
Countries
Bangladesh
Locations

Alikadam Upazila Health Complex
Bāndarban 1185270, Bāndarban, Bangladesh

Lama Upazila Health Complex
Lāma 6415294, Lama, Bangladesh

Contacts

Lorenz von Seidlein
+66926486322
Lorenz@tropmedres.ac

Rupam Tripura
+8801572288558
Rupam@tropmedres.ac

Not Provided

University of Oxford
NCT Number
Keywords
Plasmodium Falciparum Malaria
Malaria Vaccine
MeSH Terms
Malaria, Falciparum
Malaria