Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS

NCT01450280 | Completed Phase 1 DMC

• 1 other identifier: VAC038
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Safety assessment of new candidate malaria vaccines ChAd63 CS

  To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.

  Participants will be followed for the duration of the study, an expected average of 12 months

Secondary Outcomes (1)

• Assessment of immune response induced by vaccination

  Participants will be followed for the duration of the study, an expected average of 12 months

Study Arms (4)

Group 1A

EXPERIMENTAL

AdCh63 CS 5x10\^9 vp

Biological: ChAd63 CS

Group 1B

EXPERIMENTAL

ChAd63 CS 5x10\^9 vp Day 0; MVA CS 2x10\^8 pfu Day 56

Biological: ChAd63 CS, MVA CS

Group 2A

EXPERIMENTAL

AdCh63 CS 5 x 10\^10 vp

Biological: ChAd63 CS

Group 2B

EXPERIMENTAL

ChAd63 CS 5x10\^10 vp Day 0; MVA CS 2x10\^8 pfu Day 56

Biological: ChAd63, MVA CS

Interventions

ChAd63 CS BIOLOGICAL

ChAd63 CS 5x10\^9 vp intra-muscularly Day 0

Group 1A

ChAd63 CS, MVA CS BIOLOGICAL

ChAd63 CS 5x10\^9 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56

Group 1B

ChAd63, MVA CS BIOLOGICAL

ChAd63 CS 5x10\^10 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56

Group 2B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Women only: Must practice continuous effective contraception for the duration of the study
• Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study.
• Written informed consent

You may not qualify if:

• History of clinical P. falciparum malaria
• Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.
• 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 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)
• Pregnancy, breast feeding or intention to become pregnant during the study
• 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 post vaccination.
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
• History of serious psychiatric condition that may affect participation in the study.
• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital

Dublin, Ireland

Location

Related Publications (1)

• de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014.

  PMID: 25522180 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Sam McConkey

  Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)

  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: October 3, 2011
• First Posted: October 12, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

IE (1)