A Safety and Efficacy Study of ChAdOx1 LS2 and MVA LS2

NCT03203421 | Completed Phase 1

• 1 other identifier: VAC067
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, immunogenicity and efficacy of the candidate malaria vaccines ChAdOx1 LS2 and MVA LS2. Healthy adult volunteers will be recruited and vaccinated in Oxford.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• The safety and tolerability of ChAdOx1 LS2 administered alone and with MVA LS2 in a prime-boost vaccination regimen in healthy malaria-naive volunteers assessed by the frequency and severity of adverse events.

  The number of participants who experience adverse events and the severity of any adverse events.

  31 - 40 weeks

• The efficacy of ChAdOx2 LS2 and MVA LS2 administered in a prime-boost vaccination regimen against malaria sporozoite challenge, in healthy malaria-naive volunteers.

  The occurrence of Plasmodium falciparum parasitemia, assessed by blood slide and polymerase chain reaction (PCR).

  90 days

Study Arms (4)

Low Dose (Group 1)

ACTIVE COMPARATOR

One low dose of ChAdOx1 LS2 (5 x 10\^9 vp) on day 0.

Biological: ChAdOx1 LS2

Prime-Boost (Group 2)

ACTIVE COMPARATOR

One high dose of ChAdOx1 LS2 (2.5 x 10\^10 vp) on day 0 and one dose of MVA LS2 (2 x 10\^8 pfu) on day 56.

Biological: ChAdOx1 LS2; Biological: MVA LS2

Control Group A

NO INTERVENTION

No vaccinations will be administered.

Control Group B

NO INTERVENTION

No vaccinations will be administered.

Interventions

ChAdOx1 LS2 BIOLOGICAL

A viral vectored vaccine, using a chimpanzee adenovirus as a vector encoding malaria liver-stage dual antigen LS2 (LSA1 and LSAP2) fused with the transmembrane domain from shark invariant chain.

Low Dose (Group 1); Prime-Boost (Group 2)

MVA LS2 BIOLOGICAL

Modified vaccinia Ankara vector encoding liver-stage dual antigen LS2 (LSA1 ad LSAP2) fused to the C-terminal end of the leader sequence of tPA.

Prime-Boost (Group 2)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 45 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 (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
• Agreement to refrain from blood donation during the course of the study
• Provide written informed consent to participate in the trial.
• Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
• Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.
• Willingness to take a curative anti-malaria regimen following CHMI.
• For volunteers not living in Oxford: agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).
• Answer all questions on the informed consent quiz correctly.

You may not qualify if:

• History of clinical malaria (any species).
• Travel to a clearly malaria endemic locality during the study period or within the preceding six months
• Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
• 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).
• Use of immunoglobulins or blood products within 3 months prior to enrolment.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon) or malaria infection.
• Any history of anaphylaxis post vaccination.
• History of clinically significant contact dermatitis.
• Pregnancy, lactation or 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 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 standard UK units every week.
• Suspected or known injecting drug abuse in the 5 years preceding enrolment.
• Hepatitis B surface antigen (HBsAg) detected in serum.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

CCVTM, University of Oxford, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: July 3, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: June 13, 2018

Record last verified: 2017-08

Locations

GB (1)