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AzTrials

MalariaPhase 1VAC058NCT02083887

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 study testing ChAd63 ME-TRAP / MVA ME-TRAP in people with Malaria, run by University of Oxford at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 week to 16 weeksHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
ChAd63 ME-TRAP / MVA ME-TRAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteThe Gambia
Study dates
Feb 2014to Nov 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 week to 16 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • Medical Research Council Unit, Fajara

    Banjul, PO Box 273

Other trials in The Gambia

About this study

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
Malaria
Being tested
ChAd63 ME-TRAP / MVA ME-TRAP
Keywords
Immune response, Vaccine, Malaria
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAd63 ME-TRAP / MVA ME-TRAPBiological

    Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu

Study groups in NCT02083887
Study groupRoleWhat they receive
Group 1: ChAd63 ME-TRAP / MVA ME-TRAP at 16/24 weeks oldActive comparatorChAd63 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.
Receives: Biological: ChAd63 ME-TRAP / MVA ME-TRAP
Group 2: ChAd63 ME-TRAP / MVA ME-TRAP at 8/16 weeks oldActive comparatorChAd63 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
Receives: Biological: ChAd63 ME-TRAP / MVA ME-TRAP
Group 3: ChAd63 ME-TRAP / MVA ME-TRAP at 1/8 weeks oldActive comparatorChAd63 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.
Receives: Biological: ChAd63 ME-TRAP / MVA ME-TRAP
Group 4: ControlNo intervention20 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Participants will be followed for the duration of the study, an expected average of 36 weeks

Secondary outcomes (1)

  1. Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines.

    Measured: Participants will be followed for the duration of the study, an expected average of 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02083887
Sponsor's protocol ID
VAC058
Acronym
VAC058
Status last verified
Dec 2015
First submitted
28 Feb 2014
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ChAd63 ME-TRAP / MVA ME-TRAP in people with Malaria, run by University of Oxford at 1 site in The Gambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02083887, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.

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