A study to assess new malaria vaccines ChAd63 RH5 and MVA RH5 in Tanzanian adults, children and infants

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201710002722229
• Date of registration: 26/10/2017
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: A study to assess new malaria vaccines ChAd63 RH5 and MVA RH5 in Tanzanian adults, children and infants
• Scientific title: A Phase Ib age de-escalation dose-escalation randomised, double-blind, controlled study of the safety and immunogenicity of heterologous prime-boost with the candidate malaria vaccines ChAd63 RH5 and MVA RH5 administered intramuscularly according to a 0, 2-month vaccination schedule in healthy adults, young children and infants in Tanzania.
• Date of first enrolment: 08/01/2018
• Target sample size: 63
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2722
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using randomisation table created by a computer software program. ,Allocation determined by independent statistician.
• Phase: Not Applicable

Countries of recruitment

Tanzania

Contacts

• Name: Saumu Ahmed
• Affiliation: Project Manager

• Name: Simon Simon
• Affiliation: UK Senior Laboratory Investigator

Key inclusion & exclusion criteria

Inclusion criteria: Group 1: Healthy male or female adults aged 18-35 years at the time of enrolment with signed consent.
Group 1 (Female only participants): Must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent of their willingness to take Depo-Provera contraceptive during the study and safety follow-up period.
Groups 2a & 2b: Healthy male or female young children aged 1-6 years at the time of enrolment with signed consent obtained from parents or guardians.
Groups 3a & 3b: Healthy male or female infants aged 6-11 months at the time of enrolment with signed consent obtained from parents or guardians.
Planned long-term (at least 9 months from the date of recruitment) or permanent residence in Bagamoyo town.
Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or young children and infants with Z-score of weight-for-age within ±2SD.
Exclusion criteria: Clinically significant congenital abnormalities as judged by the PI or other delegated individual.Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness as judged by the PI or other delegated individual.
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
Weight for age z-scores below 2 standard deviations of normal for age.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
Any history of anaphylaxis in relation to vaccination.
Clinically significant laboratory abnormality as judged by the PI or other delegated individual.
Blood transfusion within one month of enrolment.
History of vaccination with previous experimental malaria vaccines. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG).
Any other finding which in the opinion of the PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial.
Likelihood of travel away from the study area.
Positive malaria by blood smear at screening.
Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. ¿ Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. ¿ Any other 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.


Age minimum: 6 Month(s)
Age maximum: 35 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Malaria

Intervention(s)

Group 3a

Group 2a

Group 1

Group 2b

Group 3b

Primary Outcome(s)

Adverse events (AE)

Secondary Outcome(s)

Growth inhibition activity of sera from vaccinees on a panel of Pf parasites.

Cellular immune responses to the RH5 by ELISpot assay and/or Intracellular Cytokine Staining (ICS) and/or other assays to be defined.

Avidity of anti-RH5 antibodies by ELISA and SPR and/or other assays to be defined

Antti-RH5 antibody concentration by ELIS

Secondary ID(s)

29-17

Source(s) of Monetary Support

MRC UK

Ethics review

Status: Approved
Approval date: 24/10/2017
Contact:

Ifakara Health Institute IRB

Status: Not approved
Approval date:
Contact:

National Health Research Ethics Sub-Committee

Status: Not approved
Approval date:
Contact:

Oxford Tropical Research Ethics Committee