NCT01816113

Brief Summary

This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 \& MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

March 13, 2013

Last Update Submit

May 5, 2017

Conditions

MalariaPlasmodium Vivax

Keywords

PvDBPMalariaPlasmodium vivax

Outcome Measures

Primary Outcomes (1)

  • The safety in healthy volunteers of two new candidate malaria vaccines, ChAd63 PvDBP administered alone, and with MVA PvDBP, in a prime-boost regime.

    To assess the safety of ChAd63 PvDBP when administered alone and in heterologous prime-boost with MVA PvDBP. Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study as well as abnormalities in Hematology and Biochemistry lab tests.

    Up to 20 weeks post first vaccination

Secondary Outcomes (1)

  • The humoral and cellular immunogenicity of ChAd63 PvDBP, when administered to healthy volunteers alone and with MVA PvDBP.

    U to 20 weeks post first vaccination.

Study Arms (4)

Group 1

EXPERIMENTAL

4 volunteers; 1 dose of ChAd63 PvDBP 5 x 10\^9 vp intramuscularly

Biological: ChAd63 PvDBP 5 x 10^9

Group 2A

EXPERIMENTAL

4 volunteers; 1 dose of ChAd63 PvDBP 5 x 10\^10 vp intramuscularly

Biological: ChAd63 PvDBP 5 x 10^10

Group 2B

EXPERIMENTAL

8 volunteers; 1 dose of ChAd63 PvDBP 5 x 10\^10 vp intramuscularly and 1 dose MVA PvDBP 1 x 10\^8 pfu 8 weeks later intramuscularly

Biological: ChAd63 PvDBP 5 x 10^10Biological: MVA PvDBP 1 x 10^8

Group 2C

EXPERIMENTAL

8 volunteers; 1 dose of ChAd63 PvDBP 5 x 10\^10 vp intramuscularly and 1 dose MVA PvDBP 2 x 10\^8 pfu 8 weeks later intramuscularly

Biological: ChAd63 PvDBP 5 x 10^10Biological: MVA PvDBP 2 x 10^8

Interventions

ChAd63 PvDBP 5 x 10^9BIOLOGICAL

1 dose of ChAd63 PvDBP 5 x 10\^9 vp intramuscularly

Group 1
ChAd63 PvDBP 5 x 10^10BIOLOGICAL

1 dose of ChAd63 PvDBP 5 x 10\^10 vp intramuscularly

Group 2AGroup 2BGroup 2C
MVA PvDBP 1 x 10^8BIOLOGICAL

1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly

Group 2B
MVA PvDBP 2 x 10^8BIOLOGICAL

1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly

Group 2C

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 contraception during the study and a negative pregnancy test on the day(s) of vaccination.
  • Agreement to refrain from blood donation during the course of the study.
  • Provide written informed consent.

You may not qualify if:

  • Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
  • Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
  • 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 in the 5 years preceding enrolment.
  • Seropositive for hepatitis B surface antigen (HBsAg).
  • Seropositive for hepatitis C virus (antibodies to HCV) with positive PCR for hepatitis C at screening.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

  • Payne RO, Silk SE, Elias SC, Milne KH, Rawlinson TA, Llewellyn D, Shakri AR, Jin J, Labbe GM, Edwards NJ, Poulton ID, Roberts R, Farid R, Jorgensen T, Alanine DG, de Cassan SC, Higgins MK, Otto TD, McCarthy JS, de Jongh WA, Nicosia A, Moyle S, Hill AV, Berrie E, Chitnis CE, Lawrie AM, Draper SJ. Human vaccination against Plasmodium vivax Duffy-binding protein induces strain-transcending antibodies. JCI Insight. 2017 Jun 15;2(12):e93683. doi: 10.1172/jci.insight.93683. eCollection 2017 Jun 15.

    PMID: 28614791DERIVED

MeSH Terms

Conditions

MalariaMalaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Adrian V S Hill, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 21, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

GB(1)