NCT01095055

Brief Summary

This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 AMA1, simian adenovirus encoding Plasmodium falciparum blood stage antigen, Apical Membrane Antigen -1. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 AMA1 administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA AMA1 administered via intramuscular route. Safety data will be collected for each of the eight regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

7 months

First QC Date

March 25, 2010

Last Update Submit

March 25, 2011

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • Safety of AdCh63 administered alone, and combinedwith MVA AMA1

    To assess the safety in healthy volunteers of two candidate malaria vaccines, AdCh63 AMA1 with MVA AMA1 in a prime-boost regimen. The safety of AdCh63 administered alone, and combined with MVA AMA1 will be assessed. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

    Up to 6 months following the last vaccination

Secondary Outcomes (1)

  • The level of immune response induced by vaccination with AdCh63 AMA1, when administered as a single vaccination and sequentially with MVA AMA1

    Up to 6 moths following the last vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

AdCh63 AMA1

Biological: AdCh63 AMA1

Group 2

EXPERIMENTAL

AdCh63 AMA1 followed by MVA AMA1

Biological: AdCh63 AMa1 and MVA AMA1

Interventions

AdCh63 AMA1BIOLOGICAL

Group 1A - single dose of AdCH63 AMA1 5x10\^9 vp intramuscularly Group 2A - single dose of AdCH63 AMA1 5x10\^10 vp intramuscularly

Also known as: Simian adenovirus expressing malaria antigen AMA1
Group 1
AdCh63 AMa1 and MVA AMA1BIOLOGICAL

Group 1B - single dose of AdCH63 AMA1 5x10\^9 vp intramuscularly and single dose of MVA AMA1 5x10\^8 pfu 8 weeks later intramuscularly Group 2B - single dose of AdCH63 AMA1 5x10\^10 vp intramuscularly and single dose of MVA AMA1 5x10\^8 pfu 8 weeks later intramuscularly

Also known as: Simian adenovirus, modified vaccinia Ankara virus expressing malaria antigen AMA1
Group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18 to 50 years
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  • For females only, willingness to practice continuous effective barrier contraception during the study and a negative pregnancy test on the day(s) of vaccination
  • For males only to use barrier contraception until three months after the last vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Written informed consent

You may not qualify if:

  • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of a recombinant adenoviral vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon.
  • History of clinically significant contact dermatitis
  • Any history of anaphylaxis in reaction to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • Any other serious chronic illness requiring hospital specialist supervision
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital for Tropical Diseases

London, WC1E 6JB, United Kingdom

Location

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • Sheehy SH, Duncan CJ, Elias SC, Biswas S, Collins KA, O'Hara GA, Halstead FD, Ewer KJ, Mahungu T, Spencer AJ, Miura K, Poulton ID, Dicks MD, Edwards NJ, Berrie E, Moyle S, Colloca S, Cortese R, Gantlett K, Long CA, Lawrie AM, Gilbert SC, Doherty T, Nicosia A, Hill AV, Draper SJ. Phase Ia clinical evaluation of the safety and immunogenicity of the Plasmodium falciparum blood-stage antigen AMA1 in ChAd63 and MVA vaccine vectors. PLoS One. 2012;7(2):e31208. doi: 10.1371/journal.pone.0031208. Epub 2012 Feb 21.

    PMID: 22363582DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Adrian VS Hill

    Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

GB(2)