NCT02083887

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

February 28, 2014

Last Update Submit

December 2, 2015

Conditions

Malaria

Keywords

Immune responseVaccineMalaria

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (1)

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

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

Study Arms (4)

Group 1: ChAd63 ME-TRAP / MVA ME-TRAP at 16/24 weeks old

ACTIVE COMPARATOR

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

Group 2: ChAd63 ME-TRAP / MVA ME-TRAP at 8/16 weeks old

ACTIVE COMPARATOR

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

Group 3: ChAd63 ME-TRAP / MVA ME-TRAP at 1/8 weeks old

ACTIVE COMPARATOR

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

Group 4: Control

NO INTERVENTION

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

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

Group 1: ChAd63 ME-TRAP / MVA ME-TRAP at 16/24 weeks oldGroup 2: ChAd63 ME-TRAP / MVA ME-TRAP at 8/16 weeks oldGroup 3: ChAd63 ME-TRAP / MVA ME-TRAP at 1/8 weeks old

Eligibility Criteria

Age1 Week - 16 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council Unit, Fajara

Banjul, PO Box 273, The Gambia

Location

Related Publications (1)

  • 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.

    PMID: 29213269DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Muhammed Afolabi

    Medical Research Council Unit, The Gambia Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 11, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

TH(1)