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

NCT ID: NCT01949909

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Alhydrogel CH-Alum50

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

Group Type: EXPERIMENTAL

CH-Alum50

Intervention Type: BIOLOGICAL

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

CH-GLA2.5/50

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

Group Type: EXPERIMENTAL

CH-GLA2.5/50

Intervention Type: BIOLOGICAL

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

Control rabies vaccine Verorub TM TZ Ver

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

Group Type: PLACEBO_COMPARATOR

TZ Ver

Intervention Type: BIOLOGICAL

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

Alhydrogel TZ Alum 50

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

Group Type: EXPERIMENTAL

TZ Alum 50

Intervention Type: BIOLOGICAL

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

GLA-SE TZ GLA 2.5/10

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

Group Type: EXPERIMENTAL

TZ GLA 2.5/10

Intervention Type: BIOLOGICAL

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

GLA-SE TZ GLA5/50

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

Group Type: EXPERIMENTAL

TZ GLA5/50

Intervention Type: BIOLOGICAL

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

GLA-SE TZ GLA2.5/50

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

Group Type: EXPERIMENTAL

TZ GLA2.5/50

Intervention Type: BIOLOGICAL

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

Interventions

CH-Alum50

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

Intervention Type: BIOLOGICAL

CH-GLA2.5/50

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

Intervention Type: BIOLOGICAL

TZ Ver

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

Intervention Type: BIOLOGICAL

TZ Alum 50

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

Intervention Type: BIOLOGICAL

TZ GLA 2.5/10

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

Intervention Type: BIOLOGICAL

TZ GLA5/50

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

Intervention Type: BIOLOGICAL

TZ GLA2.5/50

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers aged 18-45 years

2. General good health based on history and clinical examination

3. Written informed consent obtained before any study procedure

4. Female volunteers practicing contraception before and up to 13 weeks after the last immunisation

5. Available to participate in follow-up for the duration of study (34 weeks)

6. Reachable by phone during the whole study period

1. Healthy male volunteers aged 18-45 years

2. General good health based on history and clinical examination

3. Written informed consent obtained before any study procedure

4. Available to participate in follow-up for the duration of study (34 weeks)

5. Reachable by phone during the whole study period

6. Having always lived in an area of low malaria transmission

Exclusion Criteria

1. Positive pregnancy test for females

2. Actively breast feeding females

3. Previous participation in any malaria vaccine trial

4. 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

5. Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site

6. Enrolment in any other clinical trial during the whole trial period

7. 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

8. Volunteers unable to be closely followed for social, geographic or psychological reasons

9. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study

10. Known hypersensitivity to any of the vaccine components (adjuvant or peptide)

11. Vaccination or infusion of gammaglobulin from 4 weeks prior to the first vaccination and up to 6 weeks after the third vaccination

12. Any history of malaria

13. 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).

14. Known exposure to malaria in the previous six (6) months, defined as a visit to a malaria endemic region

15. P27A ELISA positive OR parasite ELISA antibody positive AND Known exposure to malaria in a malaria endemic area

16. P27A ELISA positive AND parasite ELISA antibody positive (with or without history of stay in a malaria endemic area)

17. Intention to travel to malaria endemic countries during the study period

18. Positive HIV, HBV or HCV tests

1. Previously participated in any malaria vaccine trial

2. 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

3. Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site

4. Enrolment in any other clinical trial during the whole trial period

5. Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the thirteen weeks preceding the screening visit or during the trial period except topical and inhaled steroids

6. Volunteers unable to be closely followed for social, geographic or psychological reasons

7. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study

8. Known hypersensitivity to any of the vaccine components (adjuvant or peptide) or to any of the control vaccine components

9. Vaccination OR infusion of gammaglobulins from four (4) weeks prior to the first vaccination and up to six (6) weeks after the third vaccination

10. Previous vaccination with the control vaccine

11. Positive HIV, HCV test or HBVsAg positive

12. Malaria parasite positivity by microscopy and/or RDT

13. Having had a history of confirmed malaria episode in the last five year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Vaccine Initiative

OTHER

Sponsor Role: collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

François Spertini

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

François Spertini, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois (CHUV)

Salim Abdulla, MD

Role: PRINCIPAL_INVESTIGATOR

Bagamoyo Research and Training Center

Locations

CHUV CRC

Lausanne, , Switzerland

Bagamoyo Clinical Trial Unit (BCTU)

Bagamoyo, , Tanzania

Countries

Switzerland; Tanzania

References

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.

Reference Type: DERIVED

PMID: 29945169 (View on PubMed)

Related Links

http://www.euvaccine.eu

European Vaccine Initiative

Other Identifiers

P27A_1_13

Identifier Type: -

Identifier Source: org_study_id