Malaria vectored vaccines and EPI co-administration trial (VAC 058)

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201402000749217
• Date of registration: 22/01/2014
• Prospective Registration: Yes
• Primary sponsor: THE JENNER INSTITUTE, UNIVERSITY OF OXFORD
• Public title: Malaria vectored vaccines and EPI co-administration trial (VAC 058)
• Scientific title: A Phase I study to assess the safety and immunogenicity of ChAd63 ME-TRAP ¿ MVA ME-TRAP heterologous prime-boost vaccination co-administered with EPI vaccines in Gambian infants
• Date of first enrolment: 03/03/2014
• Target sample size: 65
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=749
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a randomisation table created by a computer software progran,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Gambia

Contacts

• Name: Egeruan Babatunde Imoukhuede
• Affiliation: Clinical Project Manager

• Name: Muhammed Afolabi

Key inclusion & exclusion criteria

Inclusion criteria: Group 1: 15 healthy infants aged 16 weeks at the time of enrolment with signed consent obtained from parents.
Group 2: 15 healthy infants aged 8 weeks at the time of enrolment with signed consent obtained from parents.
Group 3: 15 healthy infants aged 1 week at the time of enrolment with signed consent obtained from parents.
Group 4 (control): 20 healthy infants aged 16, 8 and 1 weeks at the time of enrolment with signed consent obtained from parents
Groups 1 and 2: Receipt of all EPI vaccines according to schedule defined as follows: BCG, and first dose of OPV and Hepatitis B vaccine within 2 weeks of birth; Penta, pneumococcal vaccine, OPV, rotavirus vaccine for Group 1 at 8 weeks +/- 2 weeks.

Exclusion criteria: Birth weight less than 2.5kg
Significant antenatal, perinatal or early postnatal complications as judged by the PI or other delegated individual
Any signs of acute illness as judged by the PI or other delegated individual
Axillary temperature of greater than 37.5 °C
Clinically significant congenital abnormalities as judged by the PI or other delegated individual
¿ Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.
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.
History of splenectomy
Haemoglobin less than 10 g/dL at > 4 weeks of age or less than 13.0 g/dl at < 4 weeks of age.
White cell count <5.0 x 10^9/L
Serum Creatinine concentration greater than 60 micromol/L,
Serum ALT concentration greater than 45 U/L,
Clinically significant jaundice
Any other 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 any immunoglobulin less than two weeks before vaccination with the IMPs
Current participation in another clinical trial, or within 12 weeks of this study.
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
Maternal HIV infection (a negative maternal HIV test will be required prior to study enrolment)
Positive malaria antigen test at screening


Age minimum: 1 Week(s)
Age maximum: 16 Week(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Malaria

Intervention(s)

ChAd63 ME-TRAP

Control

Primary Outcome(s)

All solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the study vaccines

Secondary Outcome(s)

Measures of immunogenicity of ChAD63 ME-TRAP/MVA ME-TRAP prime boost immunisation where practibable to include: 1) ex vivo ELISPOT responses to overlapping pools of ME-TRAP peptides; 2) ICS and floe cytometry; 3) Antibodies to TRAP by ELISA; 4) Anti-vector immune responses; 6) Exploratory immunology including RNA analysis

Secondary ID(s)

7-14

SCC1367

Source(s) of Monetary Support

EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIAL PARTNERSHIP

Ethics review

Status: Approved
Approval date: 07/01/2014
Contact:

GAMBIA GOVERNMENT/MEDICAL RESEARCH COUNCIL JOINT ETHICS COMMITTEE

Status: Approved
Approval date: 18/02/2014
Contact:

Oxford Tropical Research Ethics Committee