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 (VAC058)

December 2, 2015 updated by: University of Oxford
Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a safe and effective vaccination strategy against malaria. The vaccines have been found to be well tolerated when tested in Gambian adults, young children and infants, who are at risk of severe malaria. Both vaccines will be given to participating infants at the same time as some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still helpful in making the body's defense system respond.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gambia
      • Banjul, Gambia, PO Box 273
        • Medical Research Council Unit, Fajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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: Bacillus Calmette-Guérin (BCG), and first dose of oral polio (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 109/L
  • Serum Creatinine concentration greater than 60 micromol/L,
  • Serum alanine aminotransferase (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1: ChAd63 ME-TRAP / MVA ME-TRAP at 16/24 weeks old
ChAd63 ME-TRAP / MVA ME-TRAP. 15 infants aged 16 weeks at time of first vaccination vaccinated with ChAd63 ME-TRAP 5 x 10^10 vp (virus particles) intramuscular (IM) at 16 weeks and MVA ME-TRAP 1 x 10^8 pfu (plaque forming units) IM at 24 weeks.
Biological: ChAd63 ME-TRAP / MVA ME-TRAP
Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu
ACTIVE_COMPARATOR: Group 2: ChAd63 ME-TRAP / MVA ME-TRAP at 8/16 weeks old
ChAd63 ME-TRAP / MVA ME-TRAP. 15 healthy infants aged 8 weeks at the time of first vaccination vaccinated with ChAd63 ME-TRAP 5 x 10^10 vp IM at 8 weeks and MVA ME-TRAP 1 x 10^8 pfu IM at 16 weeks
Biological: ChAd63 ME-TRAP / MVA ME-TRAP
Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu
ACTIVE_COMPARATOR: Group 3: ChAd63 ME-TRAP / MVA ME-TRAP at 1/8 weeks old
ChAd63 ME-TRAP / MVA ME-TRAP. 15 healthy infants aged 1 week will be vaccinated with ChAd63 ME-TRAP 5 x 10^10 vp IM at 1 week and MVA ME-TRAP 1 x 10^8 pfu IM at 8 weeks.
Biological: ChAd63 ME-TRAP / MVA ME-TRAP
Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu
NO_INTERVENTION: Group 4: Control
20 healthy infants aged 16, 8 and 1 weeks will be enrolled into this group. (Five infants will be randomised to each of Groups 1 and 2 respectively while 10 infants aged 1 week will be randomised to Group 3). All twenty infants will receive EPI vaccinations only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines
Time Frame: Participants will be followed for the duration of the study, an expected average of 36 weeks
Recording of all solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the investigative medicinal products (IMPs).
Participants will be followed for the duration of the study, an expected average of 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines.
Time Frame: Participants will be followed for the duration of the study, an expected average of 36 weeks
Participants will be followed for the duration of the study, an expected average of 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Malaria Vectored Vaccines Consortium

Investigators

  • Principal Investigator: Muhammed Afolabi, Medical Research Council Unit, The Gambia Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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