CompletedNCT02083887VAC058Updated Dec 3, 2015

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

A Phase 1 interventional study of ChAd63 ME-TRAP / MVA ME-TRAP in Malaria, sponsored by University of Oxford. Completed at 1 site in The Gambia. Open to participants aged 1 Week to 16 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by University of Oxford · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 65
Allocation: Randomized
Ages: 1 Week to 16 Weeks
Sex: All

Study summary

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.

Conditions studied

Malaria

Browse trials for

Malaria 1,315

Keywords

Immune response
Vaccine
Malaria

In context

Malaria

1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 65 is below the median of 220 across 1,041 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

Browse University of Oxford studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Week to 16 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 65 participants (actual)

Study arms

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
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
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
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.

Interventions

BiologicalChAd63 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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

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

References and documents

Publications

Mensah VA, Roetynck S, Kanteh EK, Bowyer G, Ndaw A, Oko F, Bliss CM, Jagne YJ, Cortese R, Nicosia A, Roberts R, D'Alessio F, Leroy O, Faye B, Kampmann B, Cisse B, Bojang K, Gerry S, Viebig NK, Lawrie AM, Clarke E, Imoukhuede EB, Ewer KJ, Hill AVS, Afolabi MO. Safety and Immunogenicity of Malaria Vectored Vaccines Given with Routine Expanded Program on Immunization Vaccines in Gambian Infants and Neonates: A Randomized Controlled Trial. Front Immunol. 2017 Nov 20;8:1551. doi: 10.3389/fimmu.2017.01551. eCollection 2017. PubMed 29213269 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2014, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 28, 2014
First posted: Mar 11, 2014
Start: Feb 2014
Primary completionActual: Nov 2015
CompletionActual: Nov 2015
Last update: Dec 3, 2015

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02083887
Lead sponsor: University of Oxford
Collaborators: Malaria Vectored Vaccines Consortium
Responsible party: Sponsor
First posted: Mar 11, 2014
Start date: Feb 2014
Primary completion: Nov 2015
Completion: Nov 2015
Last update: Dec 3, 2015

Study contacts

Muhammed Afolabi

principal investigator · Medical Research Council Unit, The Gambia Unit

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Malaria →

Other studies from this sponsor

University of Oxford →

Start the discussion