A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

NCT ID: NCT01635647

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-09-30

Brief Summary

Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ChAd63 ME-TRAP and MVA ME-TRAP

ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation

Group Type: ACTIVE_COMPARATOR

ChAd63 ME-TRAP and MVA ME-TRAP

Intervention Type: BIOLOGICAL

ChAd63 ME-TRAP: 5 x 10\^10vp MVA ME-TRAP: 1 x 10\^8 pfu heterologous prime-boost immunisation

Rabies vaccine

2 x 2.5IU Verorab

Group Type: PLACEBO_COMPARATOR

Rabies vaccine

Intervention Type: BIOLOGICAL

Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab

Interventions

ChAd63 ME-TRAP and MVA ME-TRAP

ChAd63 ME-TRAP: 5 x 10\^10vp MVA ME-TRAP: 1 x 10\^8 pfu heterologous prime-boost immunisation

Intervention Type: BIOLOGICAL

Rabies vaccine

Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy infant/child aged 5-17 months at the time of first study vaccination

2. Informed consent of parent/guardian

3. Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up

Exclusion Criteria

• Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
• Weight-for-age Z score of less than -3 or other clinical signs of malnutrition
• History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.
• Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
• Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator
• Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
• Blood transfusion within one month of enrolment
• Previous vaccination with experimental malaria vaccines.
• Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.
• Current participation in another clinical trial, or within 12 weeks of this study.
• Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor quality data
• Known maternal HIV infection (No testing will be done by the study team)
• Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Clinical Vaccinology and 1. Centre National de Recherche et de Formation sur le Paludisme (CNRFP)/ Unité de Recherche Clinique de Banfora (URC-B)

Ouagadougou, , Burkina Faso

Countries

Burkina Faso

References

Morter R, Tiono AB, Nebie I, Hague O, Ouedraogo A, Diarra A, Viebig NK, Hill AVS, Ewer KJ, Sirima SB. Impact of exposure to malaria and nutritional status on responses to the experimental malaria vaccine ChAd63 MVA ME-TRAP in 5-17 month-old children in Burkina Faso. Front Immunol. 2022 Dec 2;13:1058227. doi: 10.3389/fimmu.2022.1058227. eCollection 2022.

Reference Type: DERIVED

PMID: 36532031 (View on PubMed)

Tiono AB, Nebie I, Anagnostou N, Coulibaly AS, Bowyer G, Lam E, Bougouma EC, Ouedraogo A, Yaro JBB, Barry A, Roberts R, Rampling T, Bliss C, Hodgson S, Lawrie A, Ouedraogo A, Imoukhuede EB, Ewer KJ, Viebig NK, Diarra A, Leroy O, Bejon P, Hill AVS, Sirima SB. First field efficacy trial of the ChAd63 MVA ME-TRAP vectored malaria vaccine candidate in 5-17 months old infants and children. PLoS One. 2018 Dec 12;13(12):e0208328. doi: 10.1371/journal.pone.0208328. eCollection 2018.

Reference Type: DERIVED

PMID: 30540808 (View on PubMed)

Other Identifiers

VAC050

Identifier Type: -

Identifier Source: org_study_id