Evaluating the safety and immune response to RH5 blood-stage malaria vaccine in adults, young children and infants living in Tanzania
- Conditions
- Plasmodium falciparum malariaInfections and Infestations
- Registration Number
- ISRCTN47448832
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 63
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
1. Clinically significant congenital abnormalities as judged by the PI or other delegated individual
2. 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.
3. 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)
4. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
5. Weight for age z-scores below 2 standard deviations of normal for age
6. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone
7. Any history of anaphylaxis in relation to vaccination
8. Clinically significant laboratory abnormality as judged by the PI or other delegated individual
9. Blood transfusion within one month of enrolment
10. History of vaccination with previous experimental malaria vaccines
11. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
12. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
13. Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG)
14. 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
15. Likelihood of travel away from the study area
16. Positive malaria by blood smear at screening
17. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
18. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
19. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method