Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib

NCT01949909 | Completed Phase 1 DMC

• 1 other identifier: P27A_1_13
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 2

Brief Summary

P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).

Conditions

Malaria

Keywords

plasmodium falciparum; long synthetic peptide; antibody; T cell; cytokine; vaccine; safety; phase 1

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite

  The safety profile will be assessed on the basis of immediate local and systemic reactogenicity measured from Day 0 to Day 28 after each vaccination

  15 months

Secondary Outcomes (2)

• Assessment of the humoral immune response to the vaccine antigen

  15 months

• Assessment of the cellular immune response to the vaccine antigen

  15 months

Other Outcomes (3)

• Exploratory outcome measure: humoral response

  15 months

• Exploratory outcome measure: cytokine production (ICS)

  15 months

• Exploratory outcome measure : antibody dependent cell cytotoxicity (ADCI)

  15 months

Study Arms (7)

Alhydrogel CH-Alum50

EXPERIMENTAL

intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)

Biological: CH-Alum50

CH-GLA2.5/50

EXPERIMENTAL

intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

Biological: CH-GLA2.5/50

Control rabies vaccine Verorub TM TZ Ver

PLACEBO COMPARATOR

intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections

Biological: TZ Ver

Alhydrogel TZ Alum 50

EXPERIMENTAL

intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg)

Biological: TZ Alum 50

GLA-SE TZ GLA 2.5/10

EXPERIMENTAL

intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg)

Biological: TZ GLA 2.5/10

GLA-SE TZ GLA5/50

EXPERIMENTAL

intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg)

Biological: TZ GLA5/50

GLA-SE TZ GLA2.5/50

EXPERIMENTAL

intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

Biological: TZ GLA2.5/50

Interventions

CH-Alum50 BIOLOGICAL

intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)

Alhydrogel CH-Alum50

CH-GLA2.5/50 BIOLOGICAL

intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

CH-GLA2.5/50

TZ Ver BIOLOGICAL

intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections

Control rabies vaccine Verorub TM TZ Ver

TZ Alum 50 BIOLOGICAL

intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg)

Alhydrogel TZ Alum 50

TZ GLA 2.5/10 BIOLOGICAL

intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg)

GLA-SE TZ GLA 2.5/10

TZ GLA5/50 BIOLOGICAL

intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg)

GLA-SE TZ GLA5/50

TZ GLA2.5/50 BIOLOGICAL

intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

GLA-SE TZ GLA2.5/50

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers aged 18-45 years
• General good health based on history and clinical examination
• Written informed consent obtained before any study procedure
• Female volunteers practicing contraception before and up to 13 weeks after the last immunisation
• Available to participate in follow-up for the duration of study (34 weeks)
• Reachable by phone during the whole study period
• Healthy male volunteers aged 18-45 years
• General good health based on history and clinical examination
• Written informed consent obtained before any study procedure
• Available to participate in follow-up for the duration of study (34 weeks)
• Reachable by phone during the whole study period
• Having always lived in an area of low malaria transmission

You may not qualify if:

• Positive pregnancy test for females
• Actively breast feeding females
• Previous participation in any malaria vaccine trial
• Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers
• Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site
• Enrolment in any other clinical trial during the whole trial period
• Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids
• Volunteers unable to be closely followed for social, geographic or psychological reasons
• Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
• Known hypersensitivity to any of the vaccine components (adjuvant or peptide)
• Vaccination or infusion of gammaglobulin from 4 weeks prior to the first vaccination and up to 6 weeks after the third vaccination
• Any history of malaria
• History of living in a malaria endemic area for more than five (5) years OR living in a malaria endemic area in early childhood. For practical purposes, all regions for which malaria chemoprophylaxis is advised by travel clinic are considered malaria endemic (cf. www.safetravel.ch).
• Known exposure to malaria in the previous six (6) months, defined as a visit to a malaria endemic region
• P27A ELISA positive OR parasite ELISA antibody positive AND Known exposure to malaria in a malaria endemic area

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• European Vaccine Initiative: collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (2)

CHUV CRC

Lausanne, 1011, Switzerland

Location

Bagamoyo Clinical Trial Unit (BCTU)

Bagamoyo, Tanzania

Location

Related Publications (1)

• Steiner-Monard V, Kamaka K, Karoui O, Roethlisberger S, Audran R, Daubenberger C, Fayet-Mello A, Erdmann-Voisin A, Felger I, Geiger K, Govender L, Houard S, Huber E, Mayor C, Mkindi C, Portevin D, Rusch S, Schmidlin S, Tiendrebeogo RW, Theisen M, Thierry AC, Vallotton L, Corradin G, Leroy O, Abdulla S, Shekalaghe S, Genton B, Spertini F, Jongo SA. The Candidate Blood-stage Malaria Vaccine P27A Induces a Robust Humoral Response in a Fast Track to the Field Phase 1 Trial in Exposed and Nonexposed Volunteers. Clin Infect Dis. 2019 Jan 18;68(3):466-474. doi: 10.1093/cid/ciy514.

  PMID: 29945169 DERIVED

Related Links

• European Vaccine Initiative

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Study Officials

• François Spertini, MD

  Centre Hospitalier Universitaire Vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

• Salim Abdulla, MD

  Bagamoyo Research and Training Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 25, 2013
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CH (1); TA (1)